US Market News
3週前
Atossa Therapeutics Announces Closing of Registered Direct Offering of up to $16.5 Million in Gross ProceedsJune 12, 2026 5:30 PM
PR Newswire (US) $4.5 million upfront with up to an additional $12 million of potential aggregate gross proceeds upon exercise in full of warrantsSEATTLE, June 12, 2026 /PRNewswire/ -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) ("Atossa" or the "Company"), a clinical-stage biopharmaceutical company developing novel therapies in oncology and other areas of high unmet clinical need, today announced the closing of its previously announced registered direct offering of 1,363,637 shares (the "Shares") of its common stock, par value $0.18 per share ("Common Stock") (or common stock equivalents in lieu thereof), Series A warrants to purchase up to 1,363,637 shares of Common Stock and short-term Series B warrants to purchase up to 1,363,637 shares of Common Stock (such warrants, collectively, the "Series Warrants") and accompanying Series Warrants. The Series Warrants are exercisable six months following the date of issuance. The Series A warrants expire on the five and one-half (5.5) year anniversary of the date of issuance. The short-term Series B warrants expire on the two (2) year anniversary of the date of issuance. Rodman & Renshaw LLC acted as the exclusive placement agent for the offering.The aggregate gross proceeds to the Company from the offering were approximately $4.5 million before deducting the placement agent's fees and other estimated offering expenses payable by the Company. The potential additional gross proceeds to the Company from the Series Warrants, if fully exercised on a cash basis, will be approximately $12 million. No assurance can be given that any of the Series Warrants will be exercised, or that the Company will receive cash proceeds from the exercise of the Series Warrants. The Company currently intends to use the net proceeds from the offering for clinical development of its product candidates, working capital and general corporate purposes.The securities described above were offered and sold by the Company in a registered direct offering pursuant to a "shelf" registration statement on Form S-3 (File No. 333-279367) that was filed with the Securities and Exchange Commission (the "SEC"), on May 13, 2024, and declared effective by the SEC on May 23, 2024. The securities offered in the registered direct offering were offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A prospectus supplement and the accompanying base prospectus relating to the registered direct offering were filed with the SEC and are available on the SEC's website at www.sec.gov. Electronic copies of the prospectus supplement and the accompanying base prospectus may also be obtained from Rodman & Renshaw LLC at 600 Lexington Avenue, 32nd Floor, New York, NY 10022, by telephone at (212) 540-4414, or by email at info@rodm.com.This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.About Atossa TherapeuticsAtossa Therapeutics, Inc. (Nasdaq: ATOS) is a clinical-stage biopharmaceutical company developing innovative medicines in oncology and other areas of significant unmet need. The Company's lead product candidate, (Z)-endoxifen, is currently in development across several clinical settings. More information is available at https://atossatherapeutics.com.Forward-Looking StatementsThis press release contains certain "forward-looking statements" within the meaning of the Private Litigation Reform Act of 1995, including but not limited to, the timing and completion of the offering, the satisfaction of customary closing conditions related to the offering, and the intended use of proceeds therefrom. Words such as "expect," "potential," "continue," "may," "will," "should," "could," "would," "seek," "intend," "plan," "estimate," "anticipate," "believe," "design," "predict," "future," or other similar expressions or statements regarding intent, belief or current expectations, are forward-looking statements.Forward-looking statements in this press release, including those regarding the expected closing date of the offering, the satisfaction of customary closing conditions related to the offering, the intended use of proceeds from the offering, the potential exercise of the Series Warrants and potential proceeds therefrom, are subject to risks and uncertainties that may cause actual results, outcomes, or the timing of actual results or outcomes to differ materially from those projected or anticipated, including, without limitation, risks and uncertainties associated with: market and other conditions, our ability to successfully execute our strategy to shorten our clinical development timelines and pursue a Duchenne Muscular Dystrophy or McCune-Albright Syndrome indication, or other indications for our lead program, (Z)-endoxifen; expected timing, completion and results of our preclinical studies, clinical trials and research and development programs; the unpredictable relationship between preclinical study results and clinical study results; the timing or likelihood of regulatory filings and approvals; the outcome or timing of necessary regulatory approvals; our ability to maintain compliance with Nasdaq listing requirements; our ability to establish and maintain intellectual property rights covering our products; the impact of general macroeconomic conditions on our business; our ability to raise capital; and other risks and uncertainties detailed from time to time in Atossa's filings with the SEC, including, without limitation, its Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q.Forward-looking statements are presented as of the date of this press release. Except as required by law, we do not intend to update any forward-looking statements. View original content to download multimedia:https://www.prnewswire.com/news-releases/atossa-therapeutics-announces-closing-of-registered-direct-offering-of-up-to-16-5-million-in-gross-proceeds-302799448.htmlSOURCE Atossa Therapeutics Inc Original: Atossa Therapeutics Announces Closing of Registered Direct Offering of up to $16.5 Million in Gross Proceeds
US Market News
3週前
Atossa Therapeutics Announces Registered Direct Offering of up to $16.5 Million in Gross ProceedsJune 11, 2026 8:00 AM
PR Newswire (US) $4.5 million upfront with up to an additional $12 million of potential aggregate gross proceeds upon exercise in full of warrantsSEATTLE, June 11, 2026 /PRNewswire/ -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) ("Atossa" or the "Company"), a clinical-stage biopharmaceutical company developing novel therapies in oncology and other areas of high unmet clinical need, today announced that it has entered into a securities purchase agreement with institutional investors for the purchase and sale of 1,363,638 shares (the "Shares") of its common stock, par value $0.18 per share ("Common Stock") (or common stock equivalents in lieu thereof), Series A warrants to purchase up to 1,363,638 shares of Common Stock and short-term Series B warrants to purchase up to 1,363,638 shares of Common Stock (such warrants, collectively, the "Series Warrants") and accompanying Series Warrants in a registered direct offering. The Series Warrants will be exercisable six months following the date of issuance. The Series A warrants will expire on the five one-half (5.5) year anniversary of the date of issuance. The short-term Series B warrants will expire on the two (2) year anniversary of the date of issuance. The closing of the offering is expected to occur on or about June 12, 2026, subject to the satisfaction of customary closing conditions. Rodman & Renshaw LLC is acting as the exclusive placement agent for the offering.The aggregate gross proceeds to the Company from the offering are expected to be approximately $4.5 million before deducting the placement agent's fees and other estimated offering expenses payable by the Company. The potential additional gross proceeds to the Company from the Series Warrants, if fully exercised on a cash basis, will be approximately $12 million. No assurance can be given that any of the Series Warrants will be exercised, or that the Company will receive cash proceeds from the exercise of the Series Warrants. The Company currently intends to use the net proceeds from the offering for clinical development of its product candidates, working capital and general corporate purposes.The securities described above are being offered and sold by the Company in a registered direct offering pursuant to a "shelf" registration statement on Form S-3 (File No. 333-279367) that was filed with the Securities and Exchange Commission (the "SEC"), on May 13, 2024, and declared effective by the SEC on May 23, 2024. The securities offered in the registered direct offering are being offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A prospectus supplement and the accompanying base prospectus relating to the registered direct offering will be filed with the SEC and will be available on the SEC's website at www.sec.gov. Electronic copies of the prospectus supplement and the accompanying base prospectus, when available, may also be obtained from Rodman & Renshaw LLC at 600 Lexington Avenue, 32nd Floor, New York, NY 10022, by telephone at (212) 540-4414, or by email at info@rodm.com. This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.About Atossa TherapeuticsAtossa Therapeutics, Inc. (Nasdaq: ATOS) is a clinical-stage biopharmaceutical company developing innovative medicines in oncology and other areas of significant unmet need. The Company's lead product candidate, (Z)-endoxifen, is currently in development across several clinical settings. More information is available at https://atossatherapeutics.com. Forward-Looking StatementsThis press release contains certain "forward-looking statements" within the meaning of the Private Litigation Reform Act of 1995, including but not limited to, the timing and completion of the offering, the satisfaction of customary closing conditions related to the offering, and the intended use of proceeds therefrom. Words such as "expect," "potential," "continue," "may," "will," "should," "could," "would," "seek," "intend," "plan," "estimate," "anticipate," "believe," "design," "predict," "future," or other similar expressions or statements regarding intent, belief or current expectations, are forward-looking statements.Forward-looking statements in this press release, including those regarding the expected closing date of the offering, the satisfaction of customary closing conditions related to the offering, the intended use of proceeds from the offering, the potential exercise of the Series Warrants and potential proceeds therefrom, are subject to risks and uncertainties that may cause actual results, outcomes, or the timing of actual results or outcomes to differ materially from those projected or anticipated, including, without limitation, risks and uncertainties associated with: market and other conditions, our ability to successfully execute our strategy to shorten our clinical development timelines and pursue a DMD or McCune-Albright Syndrome indication or other indications for our lead program, (Z)-endoxifen; expected timing, completion and results of our preclinical studies, clinical trials and research and development programs; the unpredictable relationship between preclinical study results and clinical study results; the timing or likelihood of regulatory filings and approvals; the outcome or timing of necessary regulatory approvals; our ability to maintain compliance with Nasdaq listing requirements; our ability to establish and maintain intellectual property rights covering our products; the impact of general macroeconomic conditions on our business; our ability to raise capital; and other risks and uncertainties detailed from time to time in Atossa's filings with the SEC, including, without limitation, its Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q.Forward-looking statements are presented as of the date of this press release. Except as required by law, we do not intend to update any forward-looking statements. View original content to download multimedia:https://www.prnewswire.com/news-releases/atossa-therapeutics-announces-registered-direct-offering-of-up-to-16-5-million-in-gross-proceeds-302797596.htmlSOURCE Atossa Therapeutics Inc Original: Atossa Therapeutics Announces Registered Direct Offering of up to $16.5 Million in Gross Proceeds
US Market News
1月前
Atossa Therapeutics Announces Acceptance of Manuscript Highlighting Utrophin-Modulation Potential of (Z)-Endoxifen in Duchenne Muscular DystrophyMay 20, 2026 4:45 PM
PR Newswire (US) Review article accepted for publication in Degenerative Neurological and Neuromuscular Disease and builds on Atossa's previously published Duchenne Muscular Dystrophy (DMD) researchSEATTLE, May 20, 2026 /PRNewswire/ -- Atossa Therapeutics, Inc. (NASDAQ: ATOS) (Atossa or the Company), a clinical-stage biopharmaceutical company developing novel therapies in oncology and other areas of significant unmet clinical need, today announced that the manuscript titled, "(Z)-Endoxifen as a Potential Modulator of Utrophin Pathways in Duchenne Muscular Dystrophy: A Mechanistic and Transcriptomic Perspective," has been accepted for publication in Degenerative Neurological and Neuromuscular Disease. The review centers on utrophin, a structural and functional homolog of dystrophin. Utrophin may partially compensate for dystrophin deficiency by supporting sarcolemmal and muscle-cell membrane stability when dystrophin is absent or deficient. The manuscript describes how (Z)-endoxifen, the primary active metabolite of tamoxifen, could create a cellular environment that favors utrophin expression, localization, and function, which could potentially influence disease-relevant processes, such as protein kinase C beta-1 signaling, estrogen receptor signaling, calcium homeostasis, inflammation, fibrosis, mitochondrial function, and muscle regeneration. The authors describe (Z)-endoxifen as a compelling mechanistic candidate in treating DMD and identified next steps including preclinical evaluation in dystrophin-deficient models and biomarker development focused on utrophin expression and localization, calcium handling, PKC activity, developmental myosin, transcriptomic signatures, and muscle composition imaging."This publication advances our scientific rationale for studying (Z)-endoxifen through the lens of utrophin biology, one of the most compelling mutation-agnostic strategies in DMD," said Dr. Steven C. Quay, M.D., Ph.D., President and Chief Executive Officer of Atossa Therapeutics. "DMD remains a devastating disease with significant unmet need, and we are encouraged by the mechanistic and transcriptomic evidence suggesting that (Z)-endoxifen may help support pathways involved in utrophin-mediated muscle stabilization and repair."The new article builds on Atossa's previously published DMD manuscript in Degenerative Neurological and Neuromuscular Disease, "A Hypothesized Therapeutic Role of (Z)-Endoxifen in Duchenne Muscular Dystrophy" (L. Remmel, 2025), which introduced the broader rationale for evaluating (Z)-endoxifen in DMD. The accepted manuscript builds upon that work by placing greater emphasis on utrophin pathway biology as a potential unifying mechanism for (Z)-endoxifen's multi-pathway effects.The manuscript was authored by H. Lawrence Remmel, Sandra S. Hammer, Scott M. Blackburn, and Steven C. Quay. The authors also acknowledge input from Dame Professor Kay E. Davies, CBE FRS FMedSci, Emeritus Fellow of Hertford College, Oxford.About Duchenne Muscular DystrophyDMD is a rare, progressive neuromuscular disease caused by mutations in the DMD gene, which encodes dystrophin, a protein essential for maintaining muscle-cell structural integrity. Loss of functional dystrophin causes muscle fibers to become fragile and susceptible to contraction-induced damage, leading over time to progressive weakness, fibrosis, loss of ambulation, cardiomyopathy, respiratory failure, and premature death.About Atossa TherapeuticsAtossa Therapeutics, Inc. (Nasdaq: ATOS) is a clinical-stage biopharmaceutical company developing innovative medicines in oncology and other areas of significant unmet need. The Company's lead product candidate, (Z)-endoxifen, is currently in development across several clinical settings.(Z)-Endoxifen is a potent Selective Estrogen Receptor Modulator/Degrader (SERM/D) with demonstrated activity across multiple mechanisms of interest. Atossa is evaluating its potential applications in oncology and rare diseases. The Company's proprietary oral formulation has shown a favorable safety profile and pharmacology distinct from tamoxifen, including ER-targeted effects and PKC inhibition. Atossa's (Z)-endoxifen is not approved for any indication.Atossa has previously received Orphan Drug and Rare Pediatric Disease (RPD) designations for (Z)-endoxifen for the treatment of DMD from the FDA. Upon approval of a qualifying marketing application, drugs with RPD designation may be eligible for a Priority Review Voucher (PRV), which can be used to obtain priority review for a future application or may be sold or transferred to another sponsor. In the last 18-24 months, disclosed PRV sales have ranged from $100-$205 million.Atossa's (Z)-endoxifen program is supported by a growing global intellectual property portfolio, including multiple recently issued U.S. patents and numerous pending applications worldwide.More information is available at https://atossatherapeutics.com.Forward-Looking StatementsThis press release contains certain "forward-looking statements" within the meaning of applicable securities laws, including, but not limited to, our expectations regarding the Company's development and regulatory strategy and related milestones, including the potential indications that the Company may pursue for (Z)-endoxifen, the potential role of (Z)-endoxifen in utrophin pathway modulation, expectations regarding the design, enrollment, data, timing, results and outcomes of the Company's clinical studies, the potential for (Z)-endoxifen to receive regulatory approval and the timing thereof, the Company's potential eligibility for and the value of a Rare Pediatric Disease Priority Review Voucher, and the potential market and growth opportunities for the Company. Words such as "expect," "potential," "continue," "may," "will," "should," "could," "would," "seek," "intend," "plan," "estimate," "anticipate," "believe," "design," "predict," "future," or other similar expressions or statements regarding intent, belief or current expectations, are forward-looking statements.Forward-looking statements in this press release are subject to risks and uncertainties that may cause actual results, outcomes, or the timing of actual results or outcomes to differ materially from those projected or anticipated, including, without limitation, risks and uncertainties associated with: our ability to successfully execute our strategy to shorten our clinical development timelines and pursue a DMD indication or other indications for our lead program, (Z)-endoxifen; expected timing, completion and results of our preclinical studies, clinical trials and research and development programs; the unpredictable relationship between preclinical study results and clinical study results; the timing or likelihood of regulatory filings and approvals; the outcome or timing of necessary regulatory approvals; our ability to maintain compliance with Nasdaq listing requirements; our ability to establish and maintain intellectual property rights covering our products; the impact of general macroeconomic conditions on our business; our ability to raise capital; and other risks and uncertainties detailed from time to time in Atossa's filings with the SEC, including, without limitation, its Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q.The market value of a PRV is variable and subject to a number of factors beyond our control and reported past PRV sale amounts are not necessarily indicative of PRV sale amounts in the future.Forward-looking statements are presented as of the date of this press release. Except as required by law, we do not intend to update any forward-looking statements. View original content to download multimedia:https://www.prnewswire.com/news-releases/atossa-therapeutics-announces-acceptance-of-manuscript-highlighting-utrophin-modulation-potential-of-z-endoxifen-in-duchenne-muscular-dystrophy-302778088.htmlSOURCE Atossa Therapeutics Inc Original: Atossa Therapeutics Announces Acceptance of Manuscript Highlighting Utrophin-Modulation Potential of (Z)-Endoxifen in Duchenne Muscular Dystrophy
US Market News
2月前
Atossa Therapeutics Reports First Quarter 2026 Financial Results and Provides a Corporate UpdateMay 8, 2026 8:45 AM
PR Newswire (US) SEATTLE, May 8, 2026 /PRNewswire/ -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) (Atossa or the Company), a clinical-stage biopharmaceutical company developing novel therapies in oncology and other areas of high unmet clinical need, today announces its financial results and provides an update on recent corporate developments for the first quarter ended March 31, 2026. "During the quarter, we made meaningful progress advancing our (Z)-endoxifen development strategy across both oncology and rare disease indications," stated Dr. Steven Quay, M.D., Ph.D., Atossa Therapeutics' President and Chief Executive Officer. "We continued to advance (Z)-endoxifen in the clinic for the treatment of breast cancer, while also generating data to support its potential in rare diseases, including Duchenne Muscular Dystrophy (DMD) and McCune-Albright Syndrome. Importantly, we secured both Orphan Drug and Rare Pediatric Disease designations from the FDA for (Z)-endoxifen in DMD, and subsequently we've received Rare Pediatric Disease designation from the FDA for McCune-Albright Syndrome, reinforcing the potential of our programs in areas of high unmet need. Building on this momentum, we remain focused on identifying additional indications where our platform can deliver meaningful therapeutic benefit to patients with limited treatment options."Dr. Quay continued, "Our balance sheet remains strong, positioning us to continue to execute across our strategic plans, and deliver value to shareholders in upcoming quarters."First Quarter 2026 & Recent Highlights Atossa Therapeutics Presented Encouraging Pre-clinical data for (Z)-Endoxifen in DMD at the MDA Clinical & Scientific Conference - In an oral presentation on March 11, 2026, the Company demonstrated that (Z)-endoxifen improved muscle strength, increased lean mass, and reduced biochemical markers of muscle damage in dystrophic mouse models. We believe these data support advancement into the clinical setting.Atossa Therapeutics Received FDA Orphan Drug Designation for (Z)-Endoxifen for the Treatment of DMD - In January 2026, Atossa announced that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD) granted Orphan Drug Designation to (Z)-endoxifen for the treatment of DMD. Orphan Drug Designation is granted by the FDA to therapies intended to treat rare diseases or conditions. The designation is designed to encourage drug development by offering certain potential incentives, such as regulatory support and, if the product ultimately receives marketing approval for the designated indication, eligibility for a period of market exclusivity. The Company previously received Rare Pediatric Disease (RPD) designation for (Z)-endoxifen for the treatment of DMD.Atossa Therapeutics Received FDA RPD Designation for (Z)-Endoxifen for McCune-Albright Syndrome - In early May 2026, Atossa announced that the FDA had granted RPD for (Z)-Endoxifen for McCune-Albright Syndrome, which is the Company's second of such designations received in the last 6 months for rare diseases with currently unmet need. Upon approval of a qualifying marketing application, drugs with RPD designation may be eligible for a Priority Review Voucher (PRV), which can be used to obtain priority review for a future application or may be sold or transferred to another sponsor. In the last 18 to 24 months, disclosed PRV sales have ranged from $100–$205 million.Atossa Therapeutics Strengthened Clinical Leadership Team with the Addition of Two Experienced Biopharma Executives - Atossa announced the engagement of Kathy Puyana Theall, M.D. as Medical Director - Breast Oncology, and Adebola Giwa, M.D. as Medical Director - Rare Diseases. We believe the addition of these two highly experienced physicians and clinical leaders meaningfully strengthens Atossa's ability to execute on its (Z)-endoxifen development strategy across both breast cancer and rare disease programs, including DMD and McCune-Albright Syndrome, as the Company advances toward key clinical and regulatory milestones.Financial Results for the First Quarter Ended March 31, 2026 Operating Expenses. Total operating expenses were $9.9 million for the three months ended March 31, 2026, which was an increase of $2.5 million, from total operating expenses for the three months ended March 31, 2025 of $7.4 million. Factors contributing to the increased operating expenses in the three months ended March 31, 2026 are explained below.Research & Development (R&D) Expenses. The following table provides a breakdown of major categories within R&D expenses for the three months ended March 31, 2026 and 2025, together with the dollar change and percentage change in those categories (dollars in thousands):
For the Three Months Ended
March 31,
2026
2025
Increase
(Decrease)
% Increase
(Decrease)Research and Development
Expenses
Clinical and pre-clinical trials
$3,718
$2,747
$971
35 %
Compensation
934
880
54
6 %
Professional fees and other
127
530
(403)
(76) %
Research and Development
Expenses Total
$4,779
$4,157
$622
15 %As (Z)-endoxifen is our only product candidate for which we currently incur R&D expenses, we have not further disaggregated R&D expenses by product candidate:Clinical and non-clinical trial expenses increased $1.0 million for the three ended March 31, 2026, compared to the three months ended March 31, 2025, due to increases in spend related to our (Z)-endoxifen trials, including drug development costs.The increase in R&D compensation expenses of $0.1 million for the three months ended March 31, 2026 compared to the three months ended March 31, 2025, was due primarily to increases in non-cash stock-based compensation expense of $0.1 million.The decreases in R&D professional fees and other of $0.4 million for the three months ended March 31, 2026, compared to the three months ended March 31, 2025, were primarily attributable to lower regulatory consulting fees in the first quarter of 2026 related to our (Z)-endoxifen program as compared to the same quarter in the prior year.General and Administrative (G&A) Expenses. The following table provides a breakdown of major categories within G&A expenses for the quarter ended March 31, 2026 and 2025, together with the dollar change and percentage change in those categories (dollars in thousands):
For the Three Months Ended
March 31,
2026
2025
Increase
(Decrease)
% Increase
(Decrease)General and Administrative
Expenses
Compensation
$1,311
$1,462
$(151)
(10) %
Professional fees and other
3,780
1,795
1,985
111 %
General and Administrative
Expenses Total
$5,091
$3,257
$1,834
56 %The decrease in G&A compensation expenses of $0.2 million for the three months ended March 31, 2026, compared to the three months ended March 31, 2025, was due primarily to a decrease in headcount in the current year period compared to the same period in the prior year.The increase in G&A professional fees and other of $2.0 million for the three months ended March 31, 2026, compared to the three months ended March 31, 2025, was due primarily to higher legal fees of $1.8 million, related to our ongoing patent litigation activity, which has subsequently been settled, as well as fees associated with management of our intellectual property portfolio and other legal matters.Interest Income. Interest income of $0.3 million for the quarter ended March 31, 2026 represented a decrease of $0.4 million compared to the prior year period. The decrease was due primarily to lower average cash balances invested in our money market account during the current year period relative to the same period in the prior year.About Atossa TherapeuticsAtossa Therapeutics, Inc. (Nasdaq: ATOS) is a clinical-stage biopharmaceutical company developing innovative medicines in oncology and other areas of significant unmet need. The Company's lead product candidate, (Z)-endoxifen, is currently in development across several clinical settings.(Z)-Endoxifen is a potent Selective Estrogen Receptor Modulator/Degrader (SERM/D) with demonstrated activity across multiple mechanisms of interest. Atossa is evaluating its potential applications in oncology and rare diseases. The Company's proprietary oral formulation has shown a favorable safety profile and pharmacology distinct from tamoxifen, including ER-targeted effects and PKC inhibition. Atossa's (Z)-endoxifen is not approved for any indication.Atossa has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for (Z)-endoxifen for the treatment of Duchenne Muscular Dystrophy, as well as Rare Pediatric Disease (RPD) designation for (Z)-endoxifen for the treatment of both Duchenne Muscular Dystrophy and McCune-Albright Syndrome. Upon approval of a qualifying marketing application, drugs with RPD designation may be eligible for a Priority Review Voucher (PRV), which can be used to obtain priority review for a future application or may be sold or transferred to another sponsor. In the last 18–24 months, disclosed PRV sales have ranged from $100–$205 million.Atossa's (Z)-endoxifen program is supported by a growing global intellectual property portfolio, including multiple recently issued U.S. patents and numerous pending applications worldwide.More information is available at https://atossatherapeutics.com.Forward Looking StatementsThis press release contains certain "forward-looking statements" within the meaning of applicable securities laws, including but not limited to, our 2026 outlook and our expectations regarding the Company's development and regulatory strategy and related milestones, the potential indications that the Company may pursue for (Z)-endoxifen, the potential for (Z)-endoxifen to receive regulatory approval and the timing thereof, the Company's progress across its pipeline and potential commercialization, the strength of the Company's patent portfolio, the Company's potential eligibility for and the value of a Rare Pediatric Disease Priority Review Voucher (PRV), and the potential market and growth opportunities for the Company. Words such as "expect," "potential," "continue," "may," "will," "should," "could," "would," "seek," "intend," "plan," "estimate," "anticipate," "believe," "design," "predict," "future," or other similar expressions or statements regarding intent, belief or current expectations, are forward-looking statements.Forward-looking statements in this press release are subject to risks and uncertainties that may cause actual results, outcomes, or the timing of actual results or outcomes to differ materially from those projected or anticipated, including, without limitation, risks and uncertainties associated with: our ability to successfully execute our strategy to shorten our clinical development timelines and pursue a DMD or McCune-Albright Syndrome indication or other indications for our lead program, (Z)-endoxifen; expected timing, completion and results of our preclinical studies, clinical trials, and research and development programs; the unpredictable relationship between preclinical study results and clinical study results; the timing or likelihood of regulatory filings and approvals; the outcome or timing of necessary regulatory approvals; our ability to receive orphan-drug exclusivity for (Z)-endoxifen for DMD; our ability to maintain compliance with Nasdaq listing requirements; our ability to establish and maintain intellectual property rights covering our products; the impact of general macroeconomic conditions on our business; our ability to raise capital; and other risks and uncertainties detailed from time to time in Atossa's filings with the SEC, including, without limitation, its Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q.The market value of a PRV is variable and subject to a number of factors beyond our control and reported past PRV sale amounts are not necessarily indicative of PRV sale amounts in the future.Forward-looking statements are presented as of the date of this press release. Except as required by law, we do not intend to update any forward-looking statements.ATOSSA THERAPEUTICS, INC.CONDENSED CONSOLIDATED BALANCE SHEETS(amounts in thousands, except share and per share data)(Unaudited)
March 31, 2026
December 31, 2025Assets
Current assets
Cash and cash equivalents
$31,718
$41,299Restricted cash
110
110Prepaid materials
3,013
3,081Prepaid expenses and other current assets
1,827
1,128Total current assets
36,668
45,618Other assets
1,275
1,990Total assets
$37,943
$47,608
Liabilities and stockholders' equity
Current liabilities
Accounts payable
$2,569
$4,293Accrued expenses
2,807
1,307Payroll liabilities
943
1,558Other current liabilities
1,138
1,097Total current liabilities
7,457
8,255Total liabilities
7,457
8,255
Commitments and contingencies
—
—
Stockholders' equity
Convertible preferred stock - $0.001 par value; 10,000,000 shares authorized;
577 shares issued and outstanding as of March 31, 2026 and December 31, 2025
—
—Common stock - $0.18 par value; 350,000,000 shares authorized; 8,611,361 shares
issued and outstanding as of March 31, 2026 and December 31, 2025
1,550
1,550Additional paid-in capital
286,562
285,840Treasury stock, at cost; 88,003 shares of common stock at March 31, 2026 and
December 31, 2025
(1,475)
(1,475)Accumulated deficit
(256,151)
(246,562)Total stockholders' equity
30,486
39,353Total liabilities and stockholders' equity
$37,943
$47,608 ATOSSA THERAPEUTICS, INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (amounts in thousands, except share and per share data)(Unaudited)
For the Three Months Ended March 31,
2026
2025Operating expenses
Research and development
$4,779
$4,157General and administrative
5,091
3,257Total operating expenses
9,870
7,414Operating loss
(9,870)
(7,414)Interest income
309
720Other expense, net
(28)
(24)Loss before income taxes
(9,589)
(6,718)Income tax benefit
—
—Net loss
$(9,589)
$(6,718)Net loss per share of common stock - basic and diluted
$(1.11)
$(0.78)Weighted average shares outstanding used to compute net loss per share - basic and
diluted
8,622,289
8,622,289 View original content to download multimedia:https://www.prnewswire.com/news-releases/atossa-therapeutics-reports-first-quarter-2026-financial-results-and-provides-a-corporate-update-302766510.htmlSOURCE Atossa Therapeutics Inc Original: Atossa Therapeutics Reports First Quarter 2026 Financial Results and Provides a Corporate Update
US Market News
3月前
Atossa Therapeutics Reports Fourth Quarter and Year-End 2025 Financial Results and Provides a Corporate UpdateMarch 25, 2026 5:30 PM
PR Newswire (US)
SEATTLE, March 25, 2026 /PRNewswire/ -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) (Atossa or the Company), a clinical-stage biopharmaceutical company developing novel therapies in oncology and other areas of high unmet clinical need, today announces its financial results for the fourth quarter and year ended December 31, 2025 and provides an update on recent corporate developments.
"While we have consistently made meaningful and measurable progress across our (Z)-endoxifen development strategy in oncology over the last 12 months, we continue to explore the best opportunities to leverage the technology where it may help to address serious health conditions and unmet medical needs. As we continue to keep a careful eye on opportunities in the breast cancer space, we are also diligently working to advance (Z)-endoxifen in certain rare disease indications, such as Duchenne Muscular Dystrophy (DMD) and McCune-Albright Syndrome (MAS)," stated Dr. Steven Quay, M.D., Ph.D., Atossa Therapeutics' President and Chief Executive Officer. "To date, we have published work that identifies the opportunity for (Z)-endoxifen, while achieving both FDA Rare Pediatric Disease and Orphan Drug designations. We believe these FDA designations are important for future development as they both help to speed the FDA review process as well as provide potential financial benefits in the future.""In the meantime, we are consciously aligning our resources with the demands of potential commercialization, even as we have added new professionals to our team to help drive both our rare disease and breast cancer programs forward. With a strong balance sheet and a strategically focused team, we believe we are well-positioned to execute and advance our clinical programs toward key value-creating milestones," concluded Dr. Quay.Clinical & Regulatory Progress & AnnouncementsAtossa Highlighted Emerging Opportunity for (Z)-Endoxifen in Duchenne Muscular Dystrophy, Including Symptomatic Female Carriers, Following Peer-Reviewed Publication and Scientific Presentation - The published article, "A Hypothesized Therapeutic Role of (Z)-Endoxifen in Duchenne Muscular Dystrophy (DMD)," surveys the DMD treatment landscape and details how (Z)-endoxifen's pharmacology could address multiple downstream drivers of disease, including inflammation, fibrosis, calcium dysregulation, mitochondrial dysfunction, and lipid abnormalities. The paper emphasizes (Z)-endoxifen's direct estrogen-receptor (ER) modulation, allosteric inhibition of PKC (notably PKC-ß1), and effects along AKT/mTOR and NF-?B axes, mechanisms that together may help slow disease progression when used as an adjunct to standard care. Notably, the authors underscore (Z)-endoxifen's potential to deliver more consistent therapeutic exposures than tamoxifen by bypassing CYP2D6 metabolic variability, an important limitation of the pro-drug approach. As illustrated in the mechanistic diagram, page 7 of the publication, the paper maps (Z)-endoxifen's ER-dependent and ER-independent signaling effects relevant to dystrophic muscle.Atossa Therapeutics Received FDA Rare Pediatric Disease Designation for (Z)-Endoxifen for Duchenne Muscular Dystrophy - In December 2025, Atossa announced that the U.S. Food and Drug Administration ("FDA") granted Rare Pediatric Disease ("RPD") designation to (Z)-endoxifen for the treatment of DMD. RPD designation is granted to drug candidates intended to treat serious or life-threatening diseases that primarily affect individuals from birth to 18 years of age. Upon approval of a qualifying marketing application, drugs with RPD designation may be eligible for a Priority Review Voucher ("PRV"), which can be used to obtain priority review for a future application or may be sold or transferred to another sponsor. In the last 18–24 months, disclosed PRV sales have ranged from $100–$200 million.Atossa Therapeutics Won the 2025 Clinical Trials Arena Research and Development Excellence Award in Precision Endocrine Therapy Category - In December 2025, Atossa announced that it had been selected as a winner of the 2025 Clinical Trials Arena Excellence Awards. The Company was honored with the Research and Development Award in the Precision Endocrine Therapy category. Atossa earned this recognition for its innovative work advancing (Z)-endoxifen, its lead precision-engineered endocrine therapy. (Z)-endoxifen is a potent selective estrogen receptor modulator/degrader (SERM/D) with additional PKCß1 inhibition, designed to provide consistent systemic exposure independent of CYP2D6 metabolism. The therapy is being evaluated across metastatic, neoadjuvant, adjuvant, and breast cancer risk-reduction settings, with an emerging application in DMD.Atossa Therapeutics Received FDA Orphan Drug Designation for (Z)-Endoxifen for the Treatment of Duchenne Muscular Dystrophy - In January 2026, Atossa announced that the U.S. Food and Drug Administration ("FDA") Office of Orphan Products Development ("OOPD") granted Orphan Drug Designation to (Z)-endoxifen for the treatment of DMD. Orphan Drug Designation is granted by FDA to therapies intended to treat rare diseases or conditions. The designation is designed to encourage drug development by offering certain potential incentives, such as regulatory support and, if the product ultimately receives marketing approval for the designated indication, eligibility for a period of market exclusivity.Atossa Announces Additions to Management TeamAtossa Therapeutics Strengthened Clinical Leadership Team with the Addition of Two Experienced Biopharma Executives - Atossa announced the engagement of Kathy Puyana Theall, M.D., as Medical Director - Breast Oncology, and Adebola Giwa, M.D., as Medical Director - Rare Diseases. We believe the addition of these two highly experienced physicians and clinical leaders meaningfully strengthens Atossa's ability to execute on its (Z)-endoxifen development strategy across both breast cancer and rare disease programs, including DMD and MAS, as the Company advances toward key clinical and regulatory milestones.Comparison of Years-Ended December 31, 2025 and 2024 Operating Expenses. Total operating expenses were $37.1 million for the year ended December 31, 2025, which was an increase of $9.5 million, from the year ended December 31, 2024 of $27.6 million. Factors contributing to the increased operating expenses in the year ended December 31, 2025 are explained below.Research & Development Expenses. The following table provides a breakdown of major categories within R&D expenses for the years ended December 31, 2025 and 2024, together with the dollar change in those categories (dollars in thousands):
For the Year Ended December 31,
20252024IncreaseIncrease (%)Research and Development Expense
Clinical and non-clinical trials$16,204$10,107$6,09760 %Compensation3,2062,9282789 %Professional fees and other1,7751,08269364 %Research and Development Expense Total$21,185$14,117$7,06850 %As (Z)-endoxifen is our only product candidate for which we currently incur R&D expenses, we have not further disaggregated R&D expenses by product candidate:Clinical and pre-clinical trial expense increased $6.1 million for the year ended December 31, 2025 compared to the prior year due to an increase in spending for the (Z)-endoxifen trials, including an increase in drug development costs.The increase in R&D compensation expense of $0.3 million for the year ended December 31, 2025 compared to the prior year was due primarily to an increase in cash compensation expense of $0.4 million resulting from an increase in headcount. This increase was partially offset by a non-cash stock-based compensation expense decrease of $0.1 million compared to the prior year due to the weighted average fair value of stock options amortizing in 2025 being lower than 2024.The increase in R&D professional fees and other of $0.7 million for the year ended December 31, 2025 compared to the prior year was primarily attributable to higher regulatory consulting fees in 2025 related to our (Z)-endoxifen program.General and Administrative (G&A) Expenses. The following table provides a breakdown of major categories within G&A expenses for the years ended December 31, 2025 and 2024, together with the dollar change in those categories (dollars in thousands):
For the Year Ended December 31,
20252024Increase
(Decrease)Increase (%)
(Decrease)General and Administrative Expense
Compensation$6,062$5,458$60411 %Professional fees and other9,1917,1642,02728 %Insurance703882(179)(20) %General and Administrative Expense Total$15,956$13,504$2,45218 % The increase in G&A compensation expense of $0.6 million for the year ended December 31, 2025 compared to the prior year was due to an increase in both cash compensation expense of $0.2 million and non-cash stock-based compensation expense of $0.4 million. The increase in cash compensation expense compared to the prior year was primarily driven by salary, bonus and severance costs for a former executive of $0.4 million, partially offset by a decrease in cash bonus related to terminations and reductions in expected bonus payouts in 2025. The non-cash stock-based compensation expense increase was driven by an increase in the fair value of grants to members of our Board of Directors (the Board) which amortize over one year.G&A professional fees and other expenses increased by $2.0 million for the year ended December 31, 2025 compared to the prior year due primarily to an increase in legal fees of $1.8 million for the year ended December 31, 2025 driven by the costs for our ongoing litigation and patent defense which increased by $1.6 million compared to the prior year. Investor relations expense increased by $0.3 million for the year ended December 31, 2025 compared to the prior year due to changes in investor outreach and broader investor relations strategy. Partially offsetting the increases, our accounting fees decreased by $0.3 million for the year ended December 31, 2025 compared to the prior year due to the inclusion of higher auditor fees associated with our 2024 Registration Statement on Form S-3 and our at the market offering facility.The decrease in G&A insurance expense of $0.2 million for the year ended December 31, 2025 compared to the prior year was due primarily to lower negotiated insurance premiums associated with our Director's and Officer's insurance and other key insurance policies in 2025.Interest Income. Interest income of $2.4 million for the year ended December 31, 2025 represented a decrease of $1.7 million compared to the prior year, and was due primarily to a decrease in the average funds invested in our money market account.Impairment Charge on Investment in Equity Securities. For the year ended December 31, 2024, we wrote down our Investment in equity securities by $1.7 million due to impairment of our investment in Dynamic Cell Therapies, Inc.About (Z)-Endoxifen(Z)-Endoxifen is a potent Selective Estrogen Receptor Modulator/Degrader (SERM/D) with demonstrated activity across multiple mechanisms of interest. Atossa is evaluating its potential applications in oncology and rare diseases. The Company's proprietary oral formulation has shown a favorable safety profile and pharmacology distinct from tamoxifen, including ER-targeted effects and PKC inhibition. Atossa's (Z)-endoxifen is not approved for any indication.Atossa's (Z)-endoxifen program is supported by a growing global intellectual property portfolio, including multiple recently issued U.S. patents and numerous pending applications worldwide.About Atossa TherapeuticsAtossa Therapeutics, Inc. (Nasdaq: ATOS) is a clinical-stage biopharmaceutical company developing innovative medicines in oncology and other areas of significant unmet need. The Company's lead product candidate, (Z)-endoxifen, is currently in development across several clinical settings. More information is available at https://atossatherapeutics.com.Forward Looking StatementsThis press release contains certain "forward-looking statements" within the meaning of applicable securities laws, including but not limited to, our 2026 outlook and our expectations regarding the Company's development and regulatory strategy and related milestones, including potential Investigational New Drug submissions, the potential indications that the Company may pursue for (Z)-endoxifen, the potential for (Z)-endoxifen to receive regulatory approval and the timing thereof, the Company's progress across its pipeline and potential commercialization, the strength of the Company's patent portfolio, the Company's potential eligibility for the Rare Pediatric Disease Priority Review Voucher (PRV) program and the value of a PRV, and the potential market and growth opportunities for the Company. Words such as "expect," "potential," "continue," "may," "will," "should," "could," "would," "seek," "intend," "plan," "estimate," "anticipate," "believe," "design," "predict," "future," or other similar expressions or statements regarding intent, belief or current expectations, are forward-looking statements.Forward-looking statements in this press release are subject to risks and uncertainties that may cause actual results, outcomes, or the timing of actual results or outcomes to differ materially from those projected or anticipated, including, without limitation, risks and uncertainties associated with: our ability to successfully execute our strategy to shorten our clinical development timelines and pursue a DMD indication or other indications for our lead program, (Z)-endoxifen; expected timing, completion and results of our preclinical studies, clinical trials and research and development programs; the unpredictable relationship between preclinical study results and clinical study results; the timing or likelihood of regulatory filings and approvals; the outcome or timing of necessary regulatory approvals; our ability to receive orphan-drug exclusivity for (Z)-endoxifen for DMD; our ability to maintain compliance with Nasdaq listing requirements; our ability to establish and maintain intellectual property rights covering our products; the impact of general macroeconomic conditions on our business; our ability to raise capital; and other risks and uncertainties detailed from time to time in Atossa's filings with the SEC, including, without limitation, its Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q.Forward-looking statements are presented as of the date of this press release. Except as required by law, we do not intend to update any forward-looking statements.ATOSSA THERAPEUTICS, INC.
CONSOLIDATED BALANCE SHEETS
(amounts in thousands, except share and per share data)
December 31, 2025December 31, 2024Assets
Current assets
Cash and cash equivalents$41,299$71,084Restricted cash
110
110Prepaid materials
3,081
2,098Prepaid expenses and other current assets
1,128
1,165Total current assets
45,618
74,457Other assets
1,990
1,987Total assets$47,608$76,444Liabilities and stockholders' equity
Current liabilities
Accounts payable$4,293$679Accrued expenses
1,307
919Payroll liabilities
1,558
1,862Other current liabilities
1,097
1,507Total current liabilities
8,225
4,967Total liabilities
8,225
4,967Commitments and contingencies
Stockholders' equity
Convertible preferred stock - $0.001 par value; 10,000,000 shares authorized;
577 and 582 shares issued and outstanding as of December 31, 2025 and
December 31, 2024, respectively
—
—Common stock - $0.18 par value; 350,000,000 shares authorized; 8,611,361
and 8,611,266 shares issued and outstanding as of December 31, 2025 and
December 31, 2024, respectively
1,550
1,550Additional paid-in capital
285,840
283,194Treasury stock, at cost; 88,003 shares of common stock at December 31, 2025
and December 31, 2024
(1,475)
(1,475)Accumulated deficit
(246,562)
(211,792)Total stockholders' equity
39,353
71,477Total liabilities and stockholders' equity$47,608$76,444 ATOSSA THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(amounts in thousands, except share and per share data)
For the Year Ended December 31,
20252024Operating expenses
Research and development$ 21,185$ 14,117General and administrative15,95613,504Total operating expenses37,14127,621Operating loss(37,141)(27,621)Impairment charge on investment in equity securities—(1,710)Interest income2,3774,050Other expense, net(6)(223)Loss before income taxes(34,770)(25,504)Income tax benefit——Net loss$ (34,770)$ (25,504)Net loss per share of common stock - basic and diluted$ (4.04)$ (3.04)Weighted average shares outstanding used to compute net loss per share - basic and diluted8,611,3218,6390,618
View original content to download multimedia:https://www.prnewswire.com/news-releases/atossa-therapeutics-reports-fourth-quarter-and-year-end-2025-financial-results-and-provides-a-corporate-update-302725388.htmlSOURCE Atossa Therapeutics Inc
Original: Atossa Therapeutics Reports Fourth Quarter and Year-End 2025 Financial Results and Provides a Corporate Update
US Market News
3月前
Atossa Therapeutics Strengthens Clinical Leadership Team with the Addition of Two Experienced Biopharma ExecutivesMarch 19, 2026 8:00 AM
PR Newswire (US)
Kathy Puyana Theall, M.D. and Adebola Giwa, M.D. bring deep expertise across oncology, rare diseases, and global clinical development to support advancement of Atossa's pipelineSEATTLE, March 19, 2026 /PRNewswire/ -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) ("Atossa" or the "Company"), a clinical-stage biopharmaceutical company developing novel therapies in oncology and other rare diseases, today announces the engagement of Kathy Puyana Theall, M.D., as Medical Director - Breast Oncology, and Adebola Giwa, M.D., as Medical Director - Rare Diseases. The addition of these two highly experienced physicians and clinical leaders meaningfully strengthens Atossa's ability to execute on its (Z)-endoxifen development strategy across both breast cancer and rare disease programs, including McCune-Albright syndrome (MAS) and Duchenne Muscular Dystrophy (DMD), as the Company advances toward key clinical and regulatory milestones.
"These additions reflect our continued investment in building a world-class clinical organization as we advance our pipeline," said Dr. Steven Quay, Atossa Therapeutics Chief Executive Officer. "Kathy brings a proven track record in late-stage oncology development and regulatory approvals in breast cancer, while Adebola contributes deep expertise in endocrine and rare disease clinical development, with extensive experience advancing innovative therapies from early clinical stages through global execution. Together, they significantly enhance our ability to efficiently advance our programs and deliver meaningful outcomes for patients."Kathy Puyana Theall, M.D.
Dr. Theall is a board-certified medical oncologist with more than 24 years of experience spanning academic medicine and the biopharmaceutical industry, including over a decade in senior clinical development roles. She brings deep expertise in breast cancer drug development and has contributed to programs supporting multiple global regulatory approvals.Most recently, Dr. Theall served as Vice President of Clinical Development – Breast Cancer at Stemline-Menarini, where she led clinical strategy and execution supporting the FDA approval of ORSERDU™ (elacestrant) in 2023 and subsequent global approvals. She also led multiple clinical trials, including the Phase Ib/II ELEVATE umbrella study evaluating combination therapies in advanced breast cancer.Previously, Dr. Theall held senior roles at Pfizer Inc., where she contributed to the clinical development of IBRANCE® (palbociclib), including the PALOMA trials that supported both accelerated and full approvals. She began her career in academic medicine, serving in leadership roles at Tufts Medical Center and as a clinical investigator across more than 40 oncology studies."Atossa is at an important stage of growth," said Dr. Theall. "The company's commitment to advancing innovative therapies in breast cancer strongly aligns with my experience and passion, and I look forward to contributing to the continued development of its pipeline."Adebola Giwa, M.D.
Dr. Giwa is a board-certified pediatrician who trained in pediatric endocrinology at Johns Hopkins and later served on the faculty. He is a physician–scientist and clinical development leader with more than 15 years of experience across academic medicine and the biopharmaceutical industry and brings deep expertise in endocrine, musculoskeletal, and rare disease drug development. He has led the strategy and execution of global clinical programs across multiple therapeutic areas, including endocrinology, musculoskeletal disorders, and nephrologyMost recently, Dr. Giwa served as Senior Medical Director at Maze Therapeutics, where was the primary clinical lead for a genetic chronic kidney disease program and additional early-stage assets, with responsibility for overall clinical strategy, global trial design, safety oversight, and regulatory positioning. He played a key role in portfolio prioritization and executive decision making and led clinical execution across North America and Europe.Prior to Maze, Dr. Giwa was Medical Director at Angitia Biopharma, where he led a global Phase 1 program and advanced the asset into Phase 2, and earlier served at Ascendis Pharma, where he managed multiple global clinical trials across Phase 1 through Phase 3 development.Dr. Giwa has extensive experience as a medical monitor and clinical lead, with deep involvement in protocol design, regulatory interactions, data monitoring committees, and cross-functional program leadership. He is also the founder of AdeBolus Medical Consulting, where he advises biopharma companies on clinical and translational strategy."I'm excited to join Atossa and contribute to the advancement of its clinical programs," said Dr. Giwa. "The opportunity to help develop innovative therapies for patients with significant unmet medical needs is incredibly meaningful, and I look forward to working with the team to advance the company's pipeline and deliver high-quality clinical data to bring new treatments forward."About Atossa TherapeuticsAtossa Therapeutics, Inc. (Nasdaq: ATOS) is a clinical-stage biopharmaceutical company developing innovative medicines in oncology and other areas of significant unmet need. The Company's lead product candidate, (Z)-Endoxifen, is currently in development across several clinical settings. More information is available at https://atossatherapeutics.com.Forward-Looking StatementsThis press release contains certain "forward-looking statements" within the meaning of applicable securities laws, including but not limited to, our expectations regarding the Company's development and regulatory strategy and related milestones, the potential indications that the Company may pursue for (Z)-Endoxifen, the potential for (Z)-Endoxifen to receive regulatory approval and the timing thereof, expectations regarding the design, enrollment, data, timing, results and outcomes of the Company's clinical studies, and the potential market and growth opportunities for the Company. Words such as "expect," "potential," "continue," "may," "will," "should," "could," "would," "seek," "intend," "plan," "estimate," "anticipate," "believe," "design," "predict," "future," or other similar expressions or statements regarding intent, belief or current expectations, are forward-looking statements.Forward-looking statements in this press release are subject to risks and uncertainties that may cause actual results, outcomes, or the timing of actual results or outcomes to differ materially from those projected or anticipated, including, without limitation, risks and uncertainties associated with: our ability to successfully execute our strategy to shorten our clinical development timelines for oncology indications, DMD indication, or other indications for our lead program, (Z)-Endoxifen; expected timing, completion and results of our preclinical studies, clinical trials and research and development programs; the unpredictable relationship between preclinical study results and clinical study results; the timing or likelihood of regulatory filings and approvals; the outcome or timing of necessary regulatory approvals; our ability to maintain compliance with Nasdaq listing requirements; our ability to establish and maintain intellectual property rights covering our products; the impact of general macroeconomic conditions on our business; our ability to raise capital; and other risks and uncertainties detailed from time to time in Atossa's filings with the SEC, including, without limitation, its Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q.Forward-looking statements are presented as of the date of this press release. Except as required by law, we do not intend to update any forward-looking statements.
View original content to download multimedia:https://www.prnewswire.com/news-releases/atossa-therapeutics-strengthens-clinical-leadership-team-with-the-addition-of-two-experienced-biopharma-executives-302718250.htmlSOURCE Atossa Therapeutics Inc
Original: Atossa Therapeutics Strengthens Clinical Leadership Team with the Addition of Two Experienced Biopharma Executives
US Market News
5月前
Atossa Therapeutics Issues Letter to Shareholders Highlighting 2025 Accomplishments and 2026 OutlookFebruary 11, 2026 8:30 AM
PR Newswire (US)
SEATTLE, Feb. 11, 2026 /PRNewswire/ -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) ("Atossa" or the "Company"), a clinical-stage biopharmaceutical company developing novel therapies in oncology and other areas of high unmet need, today issued a letter to Shareholders from Steven Quay, M.D., Ph.D., Atossa Therapeutics President and Chief Executive Officer, providing an update on the Company's clinical programs and recent events. The full text of the letter follows:
To our valued shareholders,In looking back on 2025, Atossa made meaningful progress advancing proprietary oral (Z)-endoxifen toward clear, value-creating regulatory and clinical milestones. Throughout the year, we refined our development strategy within oncology as well identifying areas of opportunity beyond oncology where (Z)-endoxifen can potentially address rare disease conditions with significant unmet need. Additionally, investments were made to continue to strengthen our intellectual property estate and deepen our leadership experience by adding key members to our leadership team that will drive regulatory and clinical progress and support future commercial readiness. (Atossa Therapeutics Investors)2025: Building Momentum Around an Accelerated Regulatory Oncology StrategyRegulatory and Development Strategy - Clarity with the FDAA major strategic milestone in late 2025 was our completion of a Type C meeting with the U.S. Food and Drug Administration (FDA) (November 17, 2025) focused on regulatory strategy for advancing (Z)-endoxifen in the breast cancer setting. We received feedback on potential expedited pathways and development options spanning metastatic disease, neoadjuvant treatment, and risk-reduction settings, helping to clarify potential routes to accelerate development and regulatory review in oncology and non-oncology indications. (Atossa Therapeutics Investors)Advancements in Breast Cancer Neoadjuvant Therapy: I-SPY 2 Endocrine Optimization Pilot (EOP) StudiesAtossa currently has several "I-SPY 2" studies underway investigating (Z)-endoxifen neoadjuvant activity as a monotherapy as well as (Z)-endoxifen as a combination therapy with two partner drugs: 1) abemaciclib (VERZENIO®), a cyclin-dependent kinase (CDK) 4/6 inhibitor marketed by Eli Lilly and Company; and 2) elagolix (ORILISSA®), a prescription medicine used to treat moderate to severe pain associated with endometriosis marketed by AbbVie, Inc.In the monotherapy arm of this trial, twenty women with newly diagnosed ER+/HER- breast cancer received daily 10 mg doses of (Z)-endoxifen for one month prior to surgery. Preliminary data indicate that (Z)-endoxifen was well tolerated and resulted in reductions in: Ki-67% (a general measure of tumor activity); functional tumor volume or FTV (as measured by MRI); and the longest diameter of the index lesions.Enrollment under the combination therapy arms of this trial involving (Z)-endoxifen with abemaciclib, and in some cases additional ovarian function suppression treatment, is nearly complete, and we expect data to be available during the second half of 2026. Enrollment in the remaining arms, involving (Z)-endoxifen in combination with elagolix and GnRH agonist, are near completion, with preliminary data expected in the second quarter of 2026, and extending into the second half of the year.Metastatic Breast Cancer UpdateDuring the fourth quarter of 2025, we submitted an IND application to the FDA, outlining a Phase 2 dosing study with Project Optimus design features, and subsequently received notice that our "Study May Proceed." However, after careful evaluation of the overall cost and timeline required to conduct Phase 2 and Phase 3 clinical trials in this indication, we have decided to pause our investment in (Z)-endoxifen for Metastatic Breast Cancer, allowing us to prioritize and focus our resources on other areas of oncology and other rare diseases with higher potential return on investments.Leveraging (Z)-Endoxifen Beyond OncologyIn addition to the oncology focus for (Z)-endoxifen, 2025 also demonstrated the broader potential of (Z)-endoxifen as a therapeutic platform in additional serious diseases. The following indications underscore the growing scientific evidence supporting the role of estrogen signaling modulation in muscle preservation and inflammation and highlights the potential of (Z)-endoxifen beyond oncology.Duchenne Muscular Dystrophy (DMD)
DMD is a serious, progressive, and fatal neuromuscular disease that primarily affects boys, leading to loss of muscle function, loss of ambulation, and life-threatening heart and respiratory complications. (Z)-Endoxifen's direct estrogen-receptor modulation, PKC inhibition, and effects on key signaling pathways could be relevant in addressing various pathologies associated with DMD, including inflammation, fibrosis, and cardiomyopathy. Through its potential ability to upregulate utrophin, (Z)-endoxifen can help stabilize muscle health, including muscle growth, repair, and fibrosis. FDA engagement commenced in Q4 2025.In December 2025 and early in 2026, Atossa received two FDA designations for (Z)-endoxifen for the treatment of DMD: 1) Rare Pediatric Disease Designation and 2) Orphan Drug Designation. These designations provide the Company with several potential strategic benefits, including incentives, such as a potential Priority Review Voucher (PRV) for future FDA applications, other regulatory support, and potential market exclusivity for a period of time. PRV's, which were recently reauthorized by legislation, could create significant value to the Company and could represent a meaningful non-dilutive value opportunity, either through use in another Atossa program or monetization through sale to another party.Women Carriers of DMD(Z)-Endoxifen has also shown potential relevance in symptomatic female Duchenne and Becker muscular dystrophy carriers, an under-recognized population in which a subset may experience skeletal-muscle symptoms or develop dilated cardiomyopathy in adult life. The work done in 2025, including our manuscript entitled, "(Z)-Endoxifen as a Modulator of Utrophin Pathways in Duchenne Muscular Dystrophy," will continue to inform our hypotheses and clinical trial protocols in 2026.McCune-Albright Syndrome (MAS)MAS is a rare, non-inherited genetic disorder caused by a postzygotic GNAS mutation, affecting bones, skin, and the endocrine system, with symptoms typically appearing in early childhood. In young girls (as early as 2 years old), early onset puberty can occur (Precocious Puberty) which can have a very significant effect on quality of life, and limit growth. (Z)-Endoxifen could prove to be an effective hormone blocker significantly reducing the effects of precocious puberty until young girls reach a more typical age for the onset of puberty and related developmental changes.Collectively, we believe these non-oncology target milestones highlight the versatility of our proprietary molecule and demonstrate how Atossa can selectively pursue high-impact opportunities outside breast cancer, without diverting resources from our core clinical and regulatory priorities.2025: Strengthening our FoundationIntellectual Property ExpansionThe (Z)-endoxifen intellectual property estate continues to be reinforced, as demonstrated by the issuance of a U.S. patent covering enteric oral formulations and methods of use, supporting the differentiated oral approach designed to preserve the active (Z)-isomer and enable consistent systemic exposure. (Atossa Therapeutics Investors)We are vigorously defending Atossa's intellectual property, which is subject of the ongoing U.S. Patent and Trademark Office (USPTO) proceedings with Intas Pharmaceuticals Ltd. This litigation seeks to invalidate certain patents owned by the Company related to the manufacturing processes for (Z)-endoxifen. The Company is pursuing multiple paths for resolution through the USPTO, as well as potential settlement terms that would be mutually acceptable to both parties. Future updates pertaining to this matter are anticipated in the first half of 2026.Team Strengthening for Execution and Commercial ReadinessExecution is strategy. During 2025, we added experienced leaders to support regulatory execution and long-term commercial preparation—most notably:Janet R. Rea, MSPH, appointed SVP, R&D, to oversee late-stage (Z)-endoxifen programs with near-term priorities of advancing clinical development and defining pathways to commercialization. (Atossa Therapeutics Investors)Appointment of Mark Daniel, CPA as Chief Financial Officer to lead finance, systems, and capital strategy aligned to commercial readiness. (Atossa Therapeutics Investors)RecognitionWe were honored to receive the 2025 Clinical Trials Arena R&D Excellence Award in the Precision Endocrine Therapy category, reflecting growing awareness of the utility of (Z)-endoxifen across oncology and other indications, as well as external validation of our focus and progress. (Atossa Therapeutics Investors)Financial Discipline and FocusThroughout 2025, we emphasized efficiency, disciplined capital allocation, and operational focus. In our Q3 2025 update, we reiterated our intent to execute against planned regulatory submissions and advance our clinical programs toward key milestones, supported by a strong balance sheet and financial discipline. (Atossa Therapeutics Investors)We entered 2026 with more than $40 million in cash and cash equivalents, which we believe supports more than one year of working capital. Additionally, in late 2025, we initiated the process to affect a reverse stock split, which was effective on February 2, 2026. We believe this will allow us to regain compliance with Nasdaq listing requirements early in 2026. With this behind us, and a strong balance sheet, we plan to continue to execute the priorities of the Company with resources aligned to those activities with the highest return on investment to the Company.2026 Outlook: Selective Expansion with Capital DisciplineIn 2026, our priorities are designed to convert strategic clarity into measurable progress:Regulatory Execution
Building on FDA feedback received in 2025, we expect 2026 to include continued regulatory interactions to further clinically-related activities for accelerated development strategy, including drug combinations and opportunities beyond oncology where appropriate. (Atossa Therapeutics Investors)Oncology Priorities, Partnership-first Approach
a) I-SPY 2: (Z)-Endoxifen Combination Therapy Partnering Opportunities
We plan to complete enrollment in the combination therapy arms of the neo-adjuvant I-SPY 2 EOP in the first half of 2026, with preliminary data becoming available throughout the year as enrollment and treatment concludes. With this data, we plan to cultivate meaningful partnership opportunities for (Z)-endoxifen as a combination therapy with existing partners (Lilly and AbbVie) as well as potential new partner candidates.
b) EVANGELINE: Complete Enrollment and Data Generation with the Mayo Clinic
Enrollment in the EVANGELINE study will conclude by mid-year with preliminary data becoming available in late 2026. (Atossa Therapeutics Investors)Non-oncology Focused Priorities
a) Evaluate funding and non-dilutive partnering opportunities related to non-oncology indications, including DMD, women carriers of DMD, MAS, and other exploratory programs, where appropriate.
b) Advance strategic planning for DMD, including assessment of development pathways and clinical trial designs that leverage the Rare Pediatric Disease and Orphan Drug designations while minimizing upfront capital requirements.
c) Preserve focus on capital efficiency, so that any expansion beyond oncology is aligned with shareholder value creation and does not detract from execution of our oncology programs.Ongoing IP Strengthening and Business Development ReadinessWe will continue investing in a durable IP foundation and the operational capabilities required to support late-stage development and, if supported by clinical data, future commercialization. (Atossa Therapeutics Investors)ClosingAtossa enters 2026 with a clear regulatory roadmap, expanded clinical evidence in oncology and areas of significant unmet need in non-oncology, strengthened leadership, and a sharpened focus on the milestones that matter. Our mission remains straightforward: develop a differentiated, patient-centered endocrine therapy that can meaningfully improve outcomes across the breast cancer spectrum and other therapeutic areas with significant unmet need, and create sustainable value for shareholders along the way. (Atossa Therapeutics Investors)Thank you for your continued support.Sincerely,
Steven Quay, M.D., Ph.D.
President and Chief Executive Officer
Atossa Therapeutics, Inc.
About (Z)-Endoxifen(Z)-Endoxifen is a potent Selective Estrogen Receptor Modulator/Degrader (SERM/SERD) with demonstrated activity across multiple mechanisms of interest. Atossa is evaluating its potential applications in oncology and rare diseases. The Company's proprietary oral formulation has shown a favorable safety profile and pharmacology distinct from tamoxifen, including ER-targeted effects and PKC inhibition. Atossa's (Z)-endoxifen is not approved for any indication.Atossa's (Z)-endoxifen program is supported by a growing global intellectual property portfolio, including multiple recently issued U.S. patents and numerous pending applications worldwide.About Atossa TherapeuticsAtossa Therapeutics, Inc. (Nasdaq: ATOS) is a clinical-stage biopharmaceutical company developing innovative medicines in oncology and other areas of significant unmet need. The Company's lead product candidate, (Z)-endoxifen, is currently in development across several clinical settings. More information is available at https://atossatherapeutics.com.Forward-Looking StatementsThis press release contains certain "forward-looking statements" within the meaning of applicable securities laws, including but not limited to, our 2026 outlook and our expectations regarding the Company's development and regulatory strategy and related milestones, the potential indications that the Company may pursue for (Z)-endoxifen, the potential for (Z)-endoxifen to receive regulatory approval and the timing thereof, the expected design and enrollment of trials and timing of data and related publications, the Company's progress across its pipeline, the strength of the Company's patent portfolio, the Company's potential eligibility for the Rare Pediatric Disease Priority Review Voucher (PRV) program and the value of a future PRV, the Company's ability to successfully defend litigation and other similar complaints, the Company's ability to establish and maintain its intellectual property rights, and the potential market and growth opportunities for the Company. Words such as "expect," "potential," "continue," "may," "will," "should," "could," "would," "seek," "intend," "plan," "estimate," "anticipate," "believe," "design," "predict," "future," or other similar expressions or statements regarding intent, belief or current expectations, are forward-looking statements.Forward-looking statements in this press release are subject to risks and uncertainties that may cause actual results, outcomes, or the timing of actual results or outcomes to differ materially from those projected or anticipated, including, without limitation, risks and uncertainties associated with: our ability to successfully execute our strategy to shorten our clinical development timelines and pursue a DMD indication or other indications for our lead program, (Z)-endoxifen; expected timing, completion and results of our preclinical studies, clinical trials and research and development programs; the unpredictable relationship between preclinical study results and clinical study results; the timing or likelihood of regulatory filings and approvals; the outcome or timing of necessary regulatory approvals; our ability to receive orphan-drug exclusivity for (Z)-endoxifen for DMD; our ability to regain and maintain compliance with Nasdaq listing requirements; our ability to establish and maintain intellectual property rights covering our products; the impact of general macroeconomic conditions on our business; our ability to raise capital; and other risks and uncertainties detailed from time to time in Atossa's filings with the SEC, including, without limitation, its Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q.Forward-looking statements are presented as of the date of this press release. Except as required by law, we do not intend to update any forward-looking statements.
View original content to download multimedia:https://www.prnewswire.com/news-releases/atossa-therapeutics-issues-letter-to-shareholders-highlighting-2025-accomplishments-and-2026-outlook-302684655.htmlSOURCE Atossa Therapeutics Inc
Original: Atossa Therapeutics Issues Letter to Shareholders Highlighting 2025 Accomplishments and 2026 Outlook
US Market News
5月前
Atossa Therapeutics Maintains Strong Market Position for (Z)-Endoxifen for Duchenne Muscular Dystrophy as Congress Reauthorizes Priority Review Voucher ProgramFebruary 5, 2026 8:30 AM
PR Newswire (US)
Atossa's Rare Pediatric Disease Designation for (Z)-endoxifen in neuromuscular diseases qualifies for a future PRV upon FDA approvalSEATTLE, Feb. 5, 2026 /PRNewswire/ -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) ("Atossa" or the "Company"), a clinical-stage biopharmaceutical company developing novel therapies in oncology and other areas of high unmet clinical need, today reaffirmed its strong market position around its Duchenne Muscular Dystrophy (DMD) program following yesterday's congressional announcement that it had passed a five-year reauthorization of the Rare Pediatric Disease Priority Review Voucher ("PRV") Program. The program extends the Company's ability to be eligible to receive a future PRV upon the U.S. Food and Drug Administration's ("FDA") approval following the FDA granting Rare Pediatric Disease ("RPD") designation to (Z)-endoxifen for the treatment of DMD late last year.
RPD designation is granted to drug candidates intended to treat serious or life-threatening diseases that primarily affect individuals from birth to 18 years of age. Upon approval of a qualifying marketing application, drugs with RPD designation may be eligible for a PRV, which can be used to obtain priority review for a future application or may be sold or transferred to another sponsor. In the last 18 months, disclosed PRV sales have ranged from $150–$200 million."The renewal of the PRV program represents an important signal from Congress that it understands the complexities and financial burden on the drug development industry. The program's continuation, along with the RPD designation, underscores the validation of the science supporting the potential of (Z)-endoxifen as a treatment for Duchenne Muscular Dystrophy," said Steven Quay, M.D., Ph.D., Atossa Therapeutics President and Chief Executive Officer. "DMD is one of the most devastating childhood diseases. Families urgently need better options beyond steroids and gene-targeted approaches. While oncology remains our core focus, this milestone highlights (Z)-endoxifen's potential as a platform therapy in both cancer and rare diseases, opening the door to potential non-dilutive value creation through the Rare Pediatric Disease program.""The passage the PRV reauthorization is a win for all children with serious and rare diseases," said Janet Rea, MSPH, Senior Vice President of Research and Development at Atossa. "We are very encouraged by emerging preclinical data with (Z)-endoxifen and its potential in DMD, and we look forward to advancing this program to the clinic for boys living with DMD. Unlike more recent therapeutic approaches, (Z)-endoxifen does not target specific exon defects, thus potentially offering a broader and more accessible treatment approach for this patient population. Having previously secured IND clearance for what is now the DMD treatment, EXONDYS 51® (eteplirsen), I am excited to further Atossa's DMD (Z)-endoxifen program."About Rare Pediatric Disease DesignationThe FDA's Rare Pediatric Disease designation is reserved for serious or life-threatening diseases that primarily affect individuals from birth to 18 years old and that meet the definition of a rare disease or condition within the meaning of Section 526 of the Federal Food, Drug & Cosmetic Act ("FD&C Act"). Drugs granted RPD designation may be eligible for a PRV upon FDA approval of a qualifying New Drug Application or Biologics License Application, provided it meets all statutory criteria under Section 529(a)(4) of the FD&C Act. A PRV may be used by the sponsor or sold or transferred to another company.About Duchenne Muscular DystrophyDuchenne Muscular Dystrophy is a rare, progressive, X-linked neuromuscular disorder caused by one or more mutation in the dystrophin gene. Symptoms typically emerge in early childhood and include progressive muscle weakness, loss of ambulation, respiratory compromise, and cardiomyopathy. DMD is uniformly fatal, often in early adulthood, and despite recent therapeutic advances, there remains a substantial unmet medical need for safe, effective, and accessible treatments.About (Z)-Endoxifen(Z)-endoxifen is a potent Selective Estrogen Receptor Modulator/Degrader (SERM/D) with demonstrated activity across multiple mechanisms of interest. Atossa is evaluating its potential applications in oncology and rare diseases. The Company's proprietary oral formulation has shown a favorable safety profile and pharmacology distinct from tamoxifen, including ER-targeted effects and PKC inhibition. Atossa's (Z)-endoxifen is not approved for any indication.Atossa's (Z)-endoxifen program is supported by a growing global intellectual property portfolio, including multiple recently issued U.S. patents and numerous pending applications worldwide.About Atossa TherapeuticsAtossa Therapeutics, Inc. (Nasdaq: ATOS) is a clinical-stage biopharmaceutical company developing innovative medicines in oncology and other areas of significant unmet need. The Company's lead product candidate, (Z)-endoxifen, is currently in development across several clinical settings. More information is available at https://atossatherapeutics.com.Forward-Looking StatementsThis press release contains certain "forward-looking statements" within the meaning of applicable securities laws, including but not limited to, our expectations regarding the Company's development and regulatory strategy and related milestones, the potential indications that the Company may pursue for (Z)-endoxifen, the potential for (Z)-endoxifen to receive regulatory approval and the timing thereof, the potential extension of the RPD Priority Review Voucher program and the Company's potential eligibility for and value of a future Priority Review Voucher, and the potential market and growth opportunities for the Company. Words such as "expect," "potential," "continue," "may," "will," "should," "could," "would," "seek," "intend," "plan," "estimate," "anticipate," "believe," "design," "predict," "future," or other similar expressions or statements regarding intent, belief or current expectations, are forward-looking statements.Forward-looking statements in this press release are subject to risks and uncertainties that may cause actual results, outcomes, or the timing of actual results or outcomes to differ materially from those projected or anticipated, including, without limitation, risks and uncertainties associated with: our ability to successfully execute our strategy to shorten our clinical development timelines and pursue a metastatic breast cancer indication, DMD indication or other indications for our lead program, (Z)-endoxifen; expected timing, completion and results of our preclinical studies, clinical trials and research and development programs; the unpredictable relationship between preclinical study results and clinical study results; the timing or likelihood of regulatory filings and approvals; the outcome or timing of necessary regulatory approvals; our ability to regain and maintain compliance with Nasdaq listing requirements; our ability to establish and maintain intellectual property rights covering our products; the impact of general macroeconomic conditions on our business; our ability to raise capital; and other risks and uncertainties detailed from time to time in Atossa's filings with the SEC, including, without limitation, its Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q.The market value of a Priority Review Voucher is variable and subject to a number of factors beyond our control and reported past PRV sale amounts are not necessarily indicative of PRV sale amounts in the future.Forward-looking statements are presented as of the date of this press release. Except as required by law, we do not intend to update any forward-looking statements.
View original content to download multimedia:https://www.prnewswire.com/news-releases/atossa-therapeutics-maintains-strong-market-position-for-z-endoxifen-for-duchenne-muscular-dystrophy-as-congress-reauthorizes-priority-review-voucher-program-302679826.htmlSOURCE Atossa Therapeutics Inc
Original: Atossa Therapeutics Maintains Strong Market Position for (Z)-Endoxifen for Duchenne Muscular Dystrophy as Congress Reauthorizes Priority Review Voucher Program
eb0783
7月前
Atossa Therapeutics Receives FDA Rare Pediatric Disease Designation for (Z)-Endoxifen for Duchenne Muscular Dystrophy
SEATTLE, Dec. 11, 2025 /PRNewswire/ -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) ("Atossa" or the "Company"), a clinical-stage biopharmaceutical company developing novel therapies in oncology and other areas of high unmet clinical need, today announced that the U.S. Food and Drug Administration ("FDA") has granted Rare Pediatric Disease ("RPD") designation to (Z)-Endoxifen for the treatment of Duchenne Muscular Dystrophy ("DMD").
RPD designation is granted to drug candidates intended to treat serious or life-threatening diseases that primarily affect individuals from birth to 18 years of age. Upon approval of a qualifying marketing application, drugs with RPD designation may be eligible for a Priority Review Voucher ("PRV"), which can be used to obtain priority review for a future application or may be sold or transferred to another sponsor. In the last 18–24 months, disclosed PRV sales have ranged from $100–$160 million.
"This designation is an important regulatory milestone for Atossa, and we believe a strong validation of the science supporting the potential of (Z)-Endoxifen as a treatment for Duchenne Muscular Dystrophy," said Steven Quay, M.D., Ph.D., Atossa Therapeutics President and Chief Executive Officer. "DMD is one of the most devastating childhood diseases. Families urgently need better options beyond steroids and gene-targeted approaches. While oncology remains our core focus, this milestone highlights (Z)-Endoxifen's potential as a platform therapy in both cancer and rare diseases, opening the door to potential non-dilutive value creation through the Rare Pediatric Disease program."
"RPD designation provides a regulatory framework and an enhanced level of interaction with the FDA as we define the clinical development path in DMD," said Janet Rea, MSPH, Senior Vice President of Research and Development at Atossa. "We are very encouraged by emerging preclinical data and by (Z)-Endoxifen's potential to be a differentiated mechanism as a potent SERM/D, and look forward to our planned advancement of this program to the clinic for boys living with DMD. Unlike more recent therapeutic approaches, (Z)-Endoxifen does not target specific exon defects, thus potentially offering a broader and more accessible treatment approach for this patient population. Having previously secured IND clearance for what is now the DMD treatment, Exondys 51® (eteplirsen), I am excited to further Atossa's DMD (Z)-Endoxifen program."
About Rare Pediatric Disease Designation
The FDA's Rare Pediatric Disease designation is reserved for serious or life-threatening diseases that primarily affect individuals from birth to 18 years old and that meet the definition of a rare disease or condition within the meaning of Section 526 of the Federal Food, Drug & Cosmetic Act ("FD&C Act").
Currently, the FDA may not award any new rare pediatric disease PRVs unless the application is (i) for a drug that is designated as a drug for a rare pediatric disease not later than December 20, 2024, and (ii) is approved under the program not later than September 30, 2026. The House has passed the Mikaela Naylon "Give Kids a Chance Act" to extend voucher-award authority to 2029, with retroactive effect, and the bill is now pending Senate action.
Assuming the program is renewed, drugs granted RPD designation may be eligible for a PRV upon FDA approval of a qualifying New Drug Application or Biologics License Application, provided it meets all statutory criteria under Section 529(a)(4) of the FD&C Act. A PRV may be used by the sponsor or sold or transferred to another company.
About Duchenne Muscular Dystrophy
Duchenne Muscular Dystrophy is a rare, progressive, X-linked neuromuscular disorder caused by mutations in the dystrophin gene. Symptoms typically emerge in early childhood and include progressive muscle weakness, loss of ambulation, respiratory compromise, and cardiomyopathy. DMD is uniformly fatal, often in early adulthood, and despite recent therapeutic advances, there remains a substantial unmet medical need for safe, effective, and accessible treatments.
About (Z)-Endoxifen
(Z)-Endoxifen is a potent Selective Estrogen Receptor Modulator/Degrader (SERM/D) with demonstrated activity across multiple mechanisms of interest. Atossa is evaluating its potential applications in oncology and rare diseases. The Company's proprietary oral formulation has shown a favorable safety profile and pharmacology distinct from tamoxifen, including ER-targeted effects and PKC inhibition. Atossa's (Z)-Endoxifen is not approved for any indication.
Atossa's (Z)-Endoxifen program is supported by a growing global intellectual property portfolio, including multiple recently issued U.S. patents and numerous pending applications worldwide.
About Atossa Therapeutics
Atossa Therapeutics, Inc. (Nasdaq: ATOS) is a clinical-stage biopharmaceutical company developing innovative medicines in oncology and other areas of significant unmet need. The Company's lead product candidate, (Z)-Endoxifen, is currently in development across several clinical settings. More information is available at https://atossatherapeutics.com.
Forward-Looking Statements
This press release contains certain "forward-looking statements" within the meaning of applicable securities laws, including but not limited to, our expectations regarding the Company's development and regulatory strategy and related milestones, the potential indications that the Company may pursue for (Z)-Endoxifen, the potential for (Z)-Endoxifen to receive regulatory approval and the timing thereof, the potential extension of the RPD Priority Review Voucher program and the Company's potential eligibility for and value of a future Priority Review Voucher, and the potential market and growth opportunities for the Company. Words such as "expect," "potential," "continue," "may," "will," "should," "could," "would," "seek," "intend," "plan," "estimate," "anticipate," "believe," "design," "predict," "future," or other similar expressions or statements regarding intent, belief or current expectations, are forward-looking statements.
Forward-looking statements in this press release are subject to risks and uncertainties that may cause actual results, outcomes, or the timing of actual results or outcomes to differ materially from those projected or anticipated, including, without limitation, risks and uncertainties associated with: our ability to successfully execute our strategy to shorten our clinical development timelines and pursue a metastatic breast cancer indication, DMD indication or other indications for our lead program, (Z)-Endoxifen; expected timing, completion and results of our preclinical studies, clinical trials and research and development programs; the unpredictable relationship between preclinical study results and clinical study results; the timing or likelihood of regulatory filings and approvals; the outcome or timing of necessary regulatory approvals; our ability to receive a Priority Review Voucher for (Z)-Endoxifen, if approved, which is subject to, among other factors, the U.S. federal government's extension of the RPD PRV program and such extension being effective retroactively; our ability to regain and maintain compliance with Nasdaq listing requirements; our ability to establish and maintain intellectual property rights covering our products; the impact of general macroeconomic conditions on our business; our ability to raise capital; and other risks and uncertainties detailed from time to time in Atossa's filings with the SEC, including, without limitation, its Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q.
The market value of a Priority Review Voucher is variable and subject to a number of factors beyond our control and reported past PRV sale amounts are not necessarily indicative of PRV sale amounts in the future.
Forward-looking statements are presented as of the date of this press release. Except as required by law, we do not intend to update any forward-looking statements.
SOURCE Atossa Therapeutics Inc
Hot Features
プレミアム
登録してリアルタイムのアラート、カスタムポートフォリオ、市場の動きを入手してください。
georgie18
13時間前
glenn1919
5月前
XenaLives
2年前
Monksdream
2年前
TrendTrade2016
2年前
メールアドレスで登録
