Stereotaxis Reports 2025 Third Quarter Financial Results




Stereotaxis Reports 2025 Third Quarter Financial Results

ST. LOUIS, Nov. 11, 2025 (GLOBE NEWSWIRE) — Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today reported financial results for the third quarter ended September 30, 2025.

“We continue to focus on driving commercial progress while advancing a robust portfolio of technologies through regulatory and development milestones,” said David Fischel, Chairman and CEO. “This is an exciting milestone-rich period in which we are demonstrating the tangible reality and initial commercial impact of our comprehensive innovation strategy.”

“Our commercial progress includes two Genesis robotic systems ordered by hospitals since our last quarterly call, with both orders from European hospitals establishing entirely new robotic programs. Third quarter recurring revenue reflects summer seasonality in procedure volumes counteracted by positive momentum with Map-iT and the early launches of MAGiC and MAGiC Sweep. MAGiC Sweep has seen particularly high interest following recent FDA clearance, with over three hundred thousand dollars in revenue within the first two months of launch. We are beginning to build a clinically and commercially impactful catheter portfolio.”

“An accelerating pace of regulatory and development activity is advancing concurrent with these commercial efforts. We were pleased yesterday to announce U.S. FDA regulatory clearance for the GenesisX robotic system. We recently announced European CE Mark receipt and FDA submission for our Synchrony digital cath lab technology. We continue to work on multiple regulatory reviews for new electrophysiology and vascular catheters, while simultaneously advancing a pipeline of catheter innovations, which will contribute to commercial results in the short and medium term. Notable among these is the ongoing review of MAGiC in the U.S. and the recently announced collaboration with CardioFocus to advance the first robotically-navigated pulsed-field ablation electrophysiology catheter solution.”

2025 Third Quarter Financial Results
Revenue for the third quarter of 2025 totaled $7.5 million. System revenue of $1.9 million and recurring revenue of $5.6 million, compared to $4.4 million and $4.8 million, respectively, in the prior year third quarter. System revenue reflects partial revenue recognition on one capital system. Recurring revenue growth reflects contributions from a full quarter of Map-iT catheter revenue and initial sales of Stereotaxis’ new proprietary robotically navigated devices, the MAGiC ablation catheter and MAGiC Sweep high-density mapping catheter.

Gross margin for the third quarter was 55% of revenue. Recurring revenue gross margin was 67% and system gross margin was 19%. Gross margins remain impacted by fixed overhead allocated over low production levels.

Operating expenses in the third quarter of $10.7 million included $4.1 million in non-cash charges for stock compensation expense, mark-to-market adjustment for acquisition related contingent earnout consideration, and amortization of acquired intangible assets. Increased operating expenses include an adjustment on acquisition related contingent earnout consideration. Excluding these non-cash charges, adjusted operating expenses in the quarter were $6.6 million, a decrease from $7.2 million in the prior year third quarter primarily due to lower general and administrative expenses.

Operating loss and net loss in the third quarter of 2025 were ($6.6) million and ($6.5) million, respectively, compared to ($6.3) million and ($6.2) million in the previous year. Adjusted operating loss and adjusted net loss for the quarter, excluding non-cash charges, were ($2.5) million and ($2.4) million, respectively, compared to ($3.1) million and ($3.0) million in the previous year. Negative free cash flow for the third quarter was consistent with the previous year at ($4.2) million.

Cash Balance and Liquidity
At September 30, 2025, Stereotaxis had cash and cash equivalents of $10.5 million and no debt. Including the $4 million Stereotaxis will receive in the upcoming second closing of the registered direct financing announced in July, Stereotaxis would have had $14.5 million in cash and no debt.

Forward Looking Expectations
Stereotaxis expects revenue in the fourth quarter of this year to exceed $9 million, with system revenue of approximately $3 million and recurring revenue greater than $6 million. This supports annual revenue growth for the current year of over 20%, in-line with previous guidance of double-digit revenue growth for the full year 2025. Sustained growth of both system and recurring revenue is expected in 2026, with quarterly revenue surpassing an average of $10 million per quarter. Stereotaxis will receive an additional $4 million in proceeds this month from the equity financing announced in July. Its balance sheet allows it to advance its transformative product ecosystem to market, fund its commercialization, and achieve profitability.

Conference Call and Webcast
Stereotaxis will host a conference call and webcast today, November 11, 2025, at 4:30 p.m. Eastern Time. To access the conference call, dial 800-715-9871 (US and Canada) or 646-307-1963 (International) and give the participant pass code 4402192. To access the live and replay webcast, please visit the investor relations section of the Stereotaxis website at www.Stereotaxis.com.

About Stereotaxis
Stereotaxis (NYSE: STXS) is a pioneer and global leader in innovative surgical robotics for minimally invasive endovascular intervention. Its mission is the discovery, development and delivery of robotic systems, instruments, and information solutions for the interventional laboratory. These innovations help physicians provide unsurpassed patient care with robotic precision and safety, expand access to minimally invasive therapy, and enhance the productivity, connectivity, and intelligence in the operating room. Stereotaxis technology has been used to treat over 150,000 patients across the United States, Europe, Asia, and elsewhere. For more information, please visit www.Stereotaxis.com.

_{This press release includes statements that may constitute “forward-looking” statements, usually containing the words “believe”, “estimate”, “project”, “expect” or similar expressions. Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially. Factors that would cause or contribute to such differences include, but are not limited to, the Company’s ability to manage expenses at sustainable levels, acceptance of the Company’s products in the marketplace, the effect of global economic conditions, including tariffs, on the ability and willingness of customers to purchase its technology, competitive factors, changes resulting from healthcare policy, dependence upon third-party vendors, timing of regulatory approvals, the impact of pandemics or other disasters, statements relating to our recent acquisition of APT, including any benefits expected from the acquisition, and other risks discussed in the Company’s periodic and other filings with the Securities and Exchange Commission. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this release. There can be no assurance that the Company will recognize revenue related to its purchase orders and other commitments because some of these purchase orders and other commitments are subject to contingencies that are outside of the Company’s control and may be revised, modified, delayed, or canceled.}

Company Contacts:
David L. Fischel
Chairman and Chief Executive Officer

Kimberly R. Peery
Chief Financial Officer

314-678-6100
Investors@Stereotaxis.com

Metagenomi Presents New Preclinical Data from MGX-001 Hemophilia A Program Supporting Advancement into Clinical Development




Metagenomi Presents New Preclinical Data from MGX-001 Hemophilia A Program Supporting Advancement into Clinical Development

MGX-001 demonstrated curative FVIII activity in non-human primates

Pre-IND regulatory meeting expected in Q4 2025 with investigational new drug (IND) and clinical trial application (CTA) submissions expected in 4Q 2026

EMERYVILLE, Calif., Nov. 11, 2025 (GLOBE NEWSWIRE) — Metagenomi, Inc. (Nasdaq: MGX) (the “Company”), an in vivo genome editing company capitalizing on its proprietary technologies to create curative genetic medicines for patients, today reported new dose range finding data from the Company’s MGX-001 hemophilia A program. The data demonstrated curative factor VIII (FVIII) activity in non-human primates (NHPs) and informs a clinical dose regimen strategy for a therapy with best-in-class treatment potential. Metagenomi intends to advance MGX-001 into clinical development.

“We are highly encouraged by the dose range finding results observed in this study where we have seen clear dose-dependent activity across both the AAV and LNP components of MGX-001, resulting in therapeutically relevant FVIII activity in each animal treated in all but the lowest AAV dose,” said Jian Irish, Ph.D., M.B.A., President and CEO of Metagenomi. “In contrast to bispecific FVIII mimetics or rebalancing therapies, MGX-001 enables endogenous production of FVIII for hemostatic regulation and restores the body’s own ability to produce FVIII for a potentially lifelong cure. Our new data builds upon an earlier study demonstrating durable and stable FVIII activity in NHPs over an approximately 19-month study, giving us confidence that our novel approach has the potential to be a curative, one-and-done treatment for patients suffering from hemophilia A. We are leveraging these results in discussions with regulators and our IND/CTA submissions are expected by the end of 2026.”

NHP study design and results:

In this preclinical dose range finding study, a single dose of AAV containing a B-domain deleted human FVIII gene was administered to 24 NHPs in six dose cohorts at varying doses from 5.0e11 vg/kg to 4.0e13 vg/kg followed by a single dose of LNP delivering the proprietary MG29-1 nuclease mRNA and associated guide RNA at either 0.2, 0.6 or 2.0 mg/kg. Each animal received a single dose of corticosteroids prior to both AAV and LNP doses.

A functional cure is generally defined as FVIII levels of 50% to 150% of normal human levels. Key highlights from the study are below:

• Therapeutically relevant levels of FVIII activity were achieved in the five highest AAV doses of the six dose cohorts
  • At a fixed LNP dose of 0.6 mg/kg and a variable AAV dose of 1.6e12 to 4e13, MGX-001 achieved average per cohort FVIII activity of 49% – 81%
  • At a fixed AAV dose of 5e12 vg/kg and a variable LNP dose of 0.2 to 2.0 mg/kg, MGX-001 achieved average per cohort FVIII activity of 17% – 72%
  • FVIII activity exhibited both AAV and LNP dose dependency with no animal exceeding 150% of normal, the maximum acceptable level of human FVIII activity
  • The treatment was well tolerated in all animals without significant elevation of liver enzymes except in the highest dose of LNP where transient elevations in liver enzymes were observed
• At a proposed clinical dose of AAV at 5e12 vg/kg and LNP at 0.6 mg/kg, MGX-001 achieved average FVIII activity of 49% within a range of 29.3% – 59.5%

The new data demonstrated improved FVIII activity with reduced variability, building upon previously announced results with the B-domain deleted FVIII construct that demonstrated durable FVIII activity over an approximately 19-month study. This earlier NHP study used a cynomolgus version of the FVIII gene (cFVIII) to avoid the confounding effects of anti-human FVIII antibodies. MGX-001 has also shown no identifiable off-target editing in a series of orthogonal assays employed to discover and validate potential off-target sites.

“The MGX-001 approach represents a potential paradigm shift for the treatment of hemophilia A patients who, even with currently approved therapies, are subject to rare but serious spontaneous bleeding events and must always ensure access to their treatment,” said Glenn F. Pierce, M.D., Ph.D., an expert in the treatment of hemophilia. “As a physician scientist, drug developer, and former hemophilia A patient myself, I can speak firsthand to the impact that a potential one-and-done curative treatment can have in enabling a new standard of life with a hemophilia-free mindset.”

About Hemophilia A

Hemophilia A is the most common X-linked inherited bleeding disorder, caused by a large variety of mutations in the FVIII gene leading to a loss of functional FVIII protein. Intracranial bleeding is of greatest concern as this can lead to major morbidity and mortality. Bleeding into joints leads to cumulative joint damage and is a major cause of morbidity. Diagnosis of severe disease typically occurs in infancy due to exaggerated bleeding in response to minor injury or routine medical procedures. Prevalence is estimated to be up to 26,500 patients in the US and more than 500,000 patients globally according to the World Federation of Hemophilia, with the vast majority of patients being male.

About Metagenomi

Metagenomi is an in vivo genome editing company capitalizing on its proprietary technologies to create curative genetic medicines for patients. The Company was founded on the science of metagenomics, the study of genetic materials recovered from the natural environment, to discover and develop a suite of novel editing tools potentially capable of correcting any type of genetic mutation found anywhere in the human genome. The Company focuses on high value programs in disease indications with well-understood biology and clearly defined clinical development and regulatory pathways. Going forward, the Company intends to continue to expand its pipeline by leveraging its proprietary genetic editing capabilities in site specific deletion, integration and correction.

MGX-001, the Company’s lead, wholly-owned development program in hemophilia A, has demonstrated a preclinical profile potentially competitive with best-in-class treatment options, including targeted genome editing and durable gene expression in a one-time treatment. MGX-001 is designed to provide curative, life-long protection from bleeding events and joint damage in adults and children with hemophilia A. The Company is also currently pursuing other secreted protein deficiencies leveraging the MGX-001 site-specific genome integration system and partnered assets targeting cardiometabolic diseases. For more information, please visit https://metagenomi.co.

Cautionary Note Regarding Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. Such statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look forward to,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions include, but are not limited to, any statements relating to our product development programs, including the timing of and our ability to conduct IND-enabling studies and make regulatory filings such as INDs, statements concerning the potential of therapies and product candidates, expectations regarding MGX-001, including the preclinical profile being potentially competitive with best-in-class treatment options, benefits of the approach and timing to submit the IND/CLA packages, and any other statements that are not historical facts. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition, and stock value. Factors that could cause actual results to differ materially from those currently anticipated include: risks relating to our growth strategy; our ability to obtain, perform under, and maintain financing and strategic agreements and relationships; risks relating to the results of research and development activities; risks relating to the timing of IND submissions and starting and completing clinical trials; uncertainties relating to preclinical and clinical testing; our dependence on third party suppliers; our ability to attract, integrate and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation and the current regulatory environment; patent and intellectual property matters; competition; the volatility of capital markets and other adverse macroeconomic factors; as well as other risks described in “Risk Factors,” in our most recent Form 10-K and other risk factors set forth from time to time in our filings with the Securities and Exchange Commission made pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.

Investor Contacts:

Stephen Jasper
Gilmartin Group
stephen@gilmartinir.com

or

Kiki Patel, PharmD
Gilmartin Group
kiki@gilmartinir.com

Stereotaxis Reports 2025 Third Quarter Financial Results




Stereotaxis Reports 2025 Third Quarter Financial Results

ST. LOUIS, Nov. 11, 2025 (GLOBE NEWSWIRE) — Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today reported financial results for the third quarter ended September 30, 2025.

“We continue to focus on driving commercial progress while advancing a robust portfolio of technologies through regulatory and development milestones,” said David Fischel, Chairman and CEO. “This is an exciting milestone-rich period in which we are demonstrating the tangible reality and initial commercial impact of our comprehensive innovation strategy.”

“Our commercial progress includes two Genesis robotic systems ordered by hospitals since our last quarterly call, with both orders from European hospitals establishing entirely new robotic programs. Third quarter recurring revenue reflects summer seasonality in procedure volumes counteracted by positive momentum with Map-iT and the early launches of MAGiC and MAGiC Sweep. MAGiC Sweep has seen particularly high interest following recent FDA clearance, with over three hundred thousand dollars in revenue within the first two months of launch. We are beginning to build a clinically and commercially impactful catheter portfolio.”

“An accelerating pace of regulatory and development activity is advancing concurrent with these commercial efforts. We were pleased yesterday to announce U.S. FDA regulatory clearance for the GenesisX robotic system. We recently announced European CE Mark receipt and FDA submission for our Synchrony digital cath lab technology. We continue to work on multiple regulatory reviews for new electrophysiology and vascular catheters, while simultaneously advancing a pipeline of catheter innovations, which will contribute to commercial results in the short and medium term. Notable among these is the ongoing review of MAGiC in the U.S. and the recently announced collaboration with CardioFocus to advance the first robotically-navigated pulsed-field ablation electrophysiology catheter solution.”

2025 Third Quarter Financial Results
Revenue for the third quarter of 2025 totaled $7.5 million. System revenue of $1.9 million and recurring revenue of $5.6 million, compared to $4.4 million and $4.8 million, respectively, in the prior year third quarter. System revenue reflects partial revenue recognition on one capital system. Recurring revenue growth reflects contributions from a full quarter of Map-iT catheter revenue and initial sales of Stereotaxis’ new proprietary robotically navigated devices, the MAGiC ablation catheter and MAGiC Sweep high-density mapping catheter.

Gross margin for the third quarter was 55% of revenue. Recurring revenue gross margin was 67% and system gross margin was 19%. Gross margins remain impacted by fixed overhead allocated over low production levels.

Operating expenses in the third quarter of $10.7 million included $4.1 million in non-cash charges for stock compensation expense, mark-to-market adjustment for acquisition related contingent earnout consideration, and amortization of acquired intangible assets. Increased operating expenses include an adjustment on acquisition related contingent earnout consideration. Excluding these non-cash charges, adjusted operating expenses in the quarter were $6.6 million, a decrease from $7.2 million in the prior year third quarter primarily due to lower general and administrative expenses.

Operating loss and net loss in the third quarter of 2025 were ($6.6) million and ($6.5) million, respectively, compared to ($6.3) million and ($6.2) million in the previous year. Adjusted operating loss and adjusted net loss for the quarter, excluding non-cash charges, were ($2.5) million and ($2.4) million, respectively, compared to ($3.1) million and ($3.0) million in the previous year. Negative free cash flow for the third quarter was consistent with the previous year at ($4.2) million.

Cash Balance and Liquidity
At September 30, 2025, Stereotaxis had cash and cash equivalents of $10.5 million and no debt. Including the $4 million Stereotaxis will receive in the upcoming second closing of the registered direct financing announced in July, Stereotaxis would have had $14.5 million in cash and no debt.

Forward Looking Expectations
Stereotaxis expects revenue in the fourth quarter of this year to exceed $9 million, with system revenue of approximately $3 million and recurring revenue greater than $6 million. This supports annual revenue growth for the current year of over 20%, in-line with previous guidance of double-digit revenue growth for the full year 2025. Sustained growth of both system and recurring revenue is expected in 2026, with quarterly revenue surpassing an average of $10 million per quarter. Stereotaxis will receive an additional $4 million in proceeds this month from the equity financing announced in July. Its balance sheet allows it to advance its transformative product ecosystem to market, fund its commercialization, and achieve profitability.

Conference Call and Webcast
Stereotaxis will host a conference call and webcast today, November 11, 2025, at 4:30 p.m. Eastern Time. To access the conference call, dial 800-715-9871 (US and Canada) or 646-307-1963 (International) and give the participant pass code 4402192. To access the live and replay webcast, please visit the investor relations section of the Stereotaxis website at www.Stereotaxis.com.

About Stereotaxis
Stereotaxis (NYSE: STXS) is a pioneer and global leader in innovative surgical robotics for minimally invasive endovascular intervention. Its mission is the discovery, development and delivery of robotic systems, instruments, and information solutions for the interventional laboratory. These innovations help physicians provide unsurpassed patient care with robotic precision and safety, expand access to minimally invasive therapy, and enhance the productivity, connectivity, and intelligence in the operating room. Stereotaxis technology has been used to treat over 150,000 patients across the United States, Europe, Asia, and elsewhere. For more information, please visit www.Stereotaxis.com.

_{This press release includes statements that may constitute “forward-looking” statements, usually containing the words “believe”, “estimate”, “project”, “expect” or similar expressions. Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially. Factors that would cause or contribute to such differences include, but are not limited to, the Company’s ability to manage expenses at sustainable levels, acceptance of the Company’s products in the marketplace, the effect of global economic conditions, including tariffs, on the ability and willingness of customers to purchase its technology, competitive factors, changes resulting from healthcare policy, dependence upon third-party vendors, timing of regulatory approvals, the impact of pandemics or other disasters, statements relating to our recent acquisition of APT, including any benefits expected from the acquisition, and other risks discussed in the Company’s periodic and other filings with the Securities and Exchange Commission. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this release. There can be no assurance that the Company will recognize revenue related to its purchase orders and other commitments because some of these purchase orders and other commitments are subject to contingencies that are outside of the Company’s control and may be revised, modified, delayed, or canceled.}

Company Contacts:
David L. Fischel
Chairman and Chief Executive Officer

Kimberly R. Peery
Chief Financial Officer

314-678-6100
Investors@Stereotaxis.com

Centessa Pharmaceuticals Announces Proposed Public Offering of American Depositary Shares




Centessa Pharmaceuticals Announces Proposed Public Offering of American Depositary Shares

BOSTON and LONDON, Nov. 11, 2025 (GLOBE NEWSWIRE) — Centessa Pharmaceuticals plc (Nasdaq: CNTA), a clinical-stage pharmaceutical company, today announced that it has commenced an underwritten public offering of American Depositary Shares (“ADSs”), each representing one ordinary share. All of the ADSs are being offered by Centessa. In addition, Centessa intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the ADSs offered in the public offering. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

Jefferies, Leerink Partners, Evercore ISI and Guggenheim Securities are acting as joint book-running managers for the offering. Oppenheimer & Co., Truist Securities and LifeSci Capital are acting as co-lead managers.

The ADSs are being offered pursuant to a registration statement on Form S-3 that was filed with the Securities and Exchange Commission (“SEC”) on September 11, 2024 and became automatically effective upon filing. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website located at http://www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering, when available, may be obtained from: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, or by telephone at (877) 821-7388, or by e-mail at Prospectus_Department@Jefferies.com; or Leerink Partners LLC, Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, telephone: (800) 808-7525 ext. 6105, email: syndicate@leerink.com; or Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, NY 10055, telephone: (888) 474-0200, email: ecm.prospectus@evercore.com; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, telephone: at (212) 518-9544, or by emailing GSEquityProspectusDelivery@guggenheimpartners.com.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, 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 registration or qualification under the securities laws of any such state or jurisdiction.

About Centessa Pharmaceuticals
Centessa Pharmaceuticals plc is a clinical-stage pharmaceutical company with a mission to discover, develop and ultimately deliver medicines that are transformational for patients. We are pioneering a new class of potential therapies within our orexin receptor 2 (OX2R) agonist program for the treatment of excessive daytime sleepiness (EDS), impaired attention, cognitive deficits, fatigue and other symptoms across neurological, neurodegenerative and neuropsychiatric disorders.

Forward Looking Statements
This press release contains forward-looking statements. Any such statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements, including those relating to Centessa’s expectations regarding the completion, timing and size of the public offering and its expectations with respect to granting the underwriters a 30-day option to purchase additional ADSs. Any forward-looking statements in this press release are based on our current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties related to completion of the proposed public offering on the anticipated terms, or at all, include, but are not limited to, market conditions and the satisfaction of customary closing conditions related to the proposed public offering. Risks concerning our programs and operations are described in additional detail in our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and our other reports, which are on file with the U.S. Securities and Exchange Commission. We explicitly disclaim any obligation to update any forward-looking statements except to the extent required by law.

Contact:
Kristen K. Sheppard, Esq.
SVP of Investor Relations
investors@centessa.com

Centessa Pharmaceuticals Announces Proposed Public Offering of American Depositary Shares




Centessa Pharmaceuticals Announces Proposed Public Offering of American Depositary Shares

BOSTON and LONDON, Nov. 11, 2025 (GLOBE NEWSWIRE) — Centessa Pharmaceuticals plc (Nasdaq: CNTA), a clinical-stage pharmaceutical company, today announced that it has commenced an underwritten public offering of American Depositary Shares (“ADSs”), each representing one ordinary share. All of the ADSs are being offered by Centessa. In addition, Centessa intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the ADSs offered in the public offering. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

Jefferies, Leerink Partners, Evercore ISI and Guggenheim Securities are acting as joint book-running managers for the offering. Oppenheimer & Co., Truist Securities and LifeSci Capital are acting as co-lead managers.

The ADSs are being offered pursuant to a registration statement on Form S-3 that was filed with the Securities and Exchange Commission (“SEC”) on September 11, 2024 and became automatically effective upon filing. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website located at http://www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering, when available, may be obtained from: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, or by telephone at (877) 821-7388, or by e-mail at Prospectus_Department@Jefferies.com; or Leerink Partners LLC, Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, telephone: (800) 808-7525 ext. 6105, email: syndicate@leerink.com; or Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, NY 10055, telephone: (888) 474-0200, email: ecm.prospectus@evercore.com; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, telephone: at (212) 518-9544, or by emailing GSEquityProspectusDelivery@guggenheimpartners.com.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, 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 registration or qualification under the securities laws of any such state or jurisdiction.

About Centessa Pharmaceuticals
Centessa Pharmaceuticals plc is a clinical-stage pharmaceutical company with a mission to discover, develop and ultimately deliver medicines that are transformational for patients. We are pioneering a new class of potential therapies within our orexin receptor 2 (OX2R) agonist program for the treatment of excessive daytime sleepiness (EDS), impaired attention, cognitive deficits, fatigue and other symptoms across neurological, neurodegenerative and neuropsychiatric disorders.

Forward Looking Statements
This press release contains forward-looking statements. Any such statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements, including those relating to Centessa’s expectations regarding the completion, timing and size of the public offering and its expectations with respect to granting the underwriters a 30-day option to purchase additional ADSs. Any forward-looking statements in this press release are based on our current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties related to completion of the proposed public offering on the anticipated terms, or at all, include, but are not limited to, market conditions and the satisfaction of customary closing conditions related to the proposed public offering. Risks concerning our programs and operations are described in additional detail in our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and our other reports, which are on file with the U.S. Securities and Exchange Commission. We explicitly disclaim any obligation to update any forward-looking statements except to the extent required by law.

Contact:
Kristen K. Sheppard, Esq.
SVP of Investor Relations
investors@centessa.com

Spectral AI Announces 2025 Third Quarter Financial Results




Spectral AI Announces 2025 Third Quarter Financial Results

Q3 Overview

• Research & Development Revenue of $3.8 Million; $15.6 Million in YTD Revenue for 2025
• Strong Cash position of $10.5 Million and progress toward FDA De Novo submission

DALLAS, Nov. 11, 2025 (GLOBE NEWSWIRE) — Spectral AI, Inc. (Nasdaq: MDAI) (“Spectral AI” or the “Company”), an artificial intelligence (AI) company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, today announced financial results for the third quarter ended September 30, 2025 and provided an update on its ongoing business activities. The Company maintained a strong cash position of $10.5 million, recorded $3.8 million in research and development revenue, and continued to advance key regulatory and operational milestones, including progress toward its De Novo FDA submission.

“Spectral AI continues to maintain operational efficiency and strengthen our cash reserves as we progressed towards our commercialization milestones. Our results of operations support our work on the following the submission of our De Novo application in June of this year to the FDA,” stated J. Michael DiMaio, MD, Chairman of the Board at Spectral AI. “We continue to focus towards bringing this innovative diagnostic device to market in the U.S. to provide clinicians with an immediate, AI trained, data driven assessment tool designed to assist clinical decision-making which may significantly improve patient outcomes.”

SELECT BUSINESS HIGHLIGHTS

Recent Corporate Developments
On October 22, 2025, following the close of the third quarter of 2025, the Company entered into a securities purchase agreement (the “Purchase Agreement”) for the sale of 3,065,000 shares of the Company’s common stock at an offering price of $1.90 per share (such transaction, the “Offering”) and completed a concurrent private placement pursuant to the Purchase Agreement (the “Private Placement”), in which the Company agreed to sell (i) warrants to purchase up to 4,000,000 shares of our common stock, and (ii) pre-funded warrants to purchase up to 935,000 shares of our common stock. The aggregate gross proceeds to the Company from the completion of the Offering and the Private Placement was approximately $7.6 million. The financial statements presented below do not include the effect of this transaction on the Company’s balance sheet.

Q3 2025 FINANCIAL RESULTS OVERVIEW
All comparisons are to the three months ended September 30, 2024 (“Q3 2024”) unless otherwise stated.

Research & Development Revenue
Research & Development Revenue for Q3 2025 declined 54% to $3.8 million from $8.2 million, reflecting the anticipated reduction in direct labor, clinical trial and other reimbursed study costs in connection with the Company’s contract with BARDA (the “BARDA PBS Contract”) following the submission of our De Novo FDA submission in June 2025.

Gross Margin
Gross margin for Q3 2025 was 42.7%, slightly down from 44.9% in Q3 2024, reflecting the reduction in direct labor, clinical trial, and other reimbursed study costs in connection with the Company’s contract with BARDA PBS Contract.

General & Administrative Expense
General and administrative expenses in Q3 2025 were $5.0 million, up from $4.6 million in Q3 2024, reflecting increased consultant and third-party service provider costs from Q3 2024.

Other Income/(Expense)

Other income/(expense) in Q3 2025 was $(0.2) million as compared to $(0.6) million in Q3 2024 primarily relating to the Company’s reduction in its borrowing related costs of almost $0.9 million from Q3 2024.

Net Income/(Loss)
The Company reported a net loss for Q3 2025 of $(3.6) million, compared to a net loss of $(1.5) million in Q3 2024, primarily due to the reduction in revenue as noted above.  

Financial Condition
As of September 30, 2025, cash improved to $10.5 million from $3.7 million in Q3 2024. In addition, the Company’s cash position has remained flat at $10.5 million from Q2 2025. The Company has continued to closely manage its operating costs and has received approximately $2.5 million from stock option and warrant exercises in Q3 2025.

2025 Guidance
The Company has reduced its revenue guidance from $21.5 million to $18.5 million for FY 2025. The reduction reflects timing of work on the BARDA contract and some impact from the current US government shutdown, much of which shall be recaptured in FY 2026. Financial guidance for FY 2025 does not reflect any contributions from the sale of the DeepView™ System for the burn indication or any additional material financial contributions that may result from the commercialization of our DeepView™ System.

CONFERENCE CALL
The Company will host a conference call today at 5:00 pm Eastern Time to discuss these results. Investors interested in participating in the live call can dial:

833-630-1956 – U.S.
412-317-1837 – International

A simultaneous webcast of the call may be accessed online from the Events & Presentations section of the Investor Relations page of the Company’s website at https://investors.spectral-ai.com/news-events/events.

About Spectral AI
Spectral AI, Inc. is a Dallas-based predictive AI company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, with initial applications involving patients with burns. The Company is working to revolutionize the management of wound care by “Seeing the Unknown^®” with its DeepView^® System. The DeepView^® System is being developed as a predictive device to offer clinicians an objective and immediate assessment of a burn wound’s healing potential prior to treatment or other medical intervention. With algorithm-driven results and a goal of exceeding the current standard of care in the future, the DeepView^® System is expected to provide fast and accurate treatment insight towards value care by improving patient outcomes and reducing healthcare costs. For more information about the DeepView^® System, visit www.spectral-ai.com.

Forward-Looking Statements
Certain statements made in this release are “forward looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995, including statements regarding the Company’s strategy, plans, objectives, initiatives and financial outlook. When used in this press release, the words “estimates,” “projected,” “expects,” “anticipates,” “forecasts,” “plans,” “intends,” “believes,” “seeks,” “may,” “will,” “should,” “future,” “propose” and variations of these words or similar expressions (or the negative versions of such words or expressions) are intended to identify forward-looking statements. These forward-looking statements are not guarantees of future performance, conditions or results, and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside Company’s control, that could cause actual results or outcomes to differ materially from those discussed in the forward-looking statements. As such, readers are cautioned not to place undue reliance on any forward-looking statements.

Investors should carefully consider the foregoing factors, and the other risks and uncertainties described in the “Risk Factors” sections of the Company’s filings with the SEC, including the Registration Statement and the other documents filed by the Company. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements.

For Media and Investor Relations, please contact:
David Kugelman
Atlanta Capital Partners LLC
(866) 692-6847 Toll Free – U.S. & Canada
(404) 281-8556 Mobile and WhatsApp Email: dk@atlcp.com

DXS INTERNATIONAL PLC (AQSE: DXSP) Notification of Director / PDMR Dealing




DXS INTERNATIONAL PLC (AQSE: DXSP) Notification of Director / PDMR Dealing

DXS INTERNATIONAL PLC (AQSE: DXSP) Notification of Director / PDMR Dealing

DXS INTERNATIONAL PLC

The Board of DXS International plc (the “Company” or “DXSP), the AQSE Growth Market quoted clinical decision support developer and supplier of clinical decision support systems, has received notification that on 11 November, Mr Bob Sutcliffe, the Chairman, purchased 50,000 Ordinary Shares in the Company at a price of 1.30p per share.

Following this transaction Mr Sutcliffe and his wife’s interest in DXS Ordinary Shares is 1,383,756 Ordinary Shares representing 2.16% of the issued share capital of the Company.

The Directors of DXS International plc accept responsibility for this announcement.

Contacts:

Notes to Editors

About DXS:
DXS International presents up to date treatment guidelines and recommendations, from Clinical Commissioning Groups and other trusted NHS sources, to doctors, nurses and pharmacists in their workflow and during the patient consultation. This effective clinical decision support ultimately translates to improved healthcare outcomes delivered more cost effectively and which should significantly contribute towards the NHS achieving its projected efficiency savings.

Attachment

• DXS Notification of Director PDMR Dealings_11 11 2025 Bob Sutcliffe

DXS INTERNATIONAL PLC (AQSE: DXSP) Notification of Director / PDMR Dealing




DXS INTERNATIONAL PLC (AQSE: DXSP) Notification of Director / PDMR Dealing

DXS INTERNATIONAL PLC (AQSE: DXSP) Notification of Director / PDMR Dealing

DXS INTERNATIONAL PLC

The Board of DXS International plc (the “Company” or “DXSP), the AQSE Growth Market quoted clinical decision support developer and supplier of clinical decision support systems, has received notification that on 11 November, Mr Bob Sutcliffe, the Chairman, purchased 50,000 Ordinary Shares in the Company at a price of 1.30p per share.

Following this transaction Mr Sutcliffe and his wife’s interest in DXS Ordinary Shares is 1,383,756 Ordinary Shares representing 2.16% of the issued share capital of the Company.

The Directors of DXS International plc accept responsibility for this announcement.

Contacts:

Notes to Editors

About DXS:
DXS International presents up to date treatment guidelines and recommendations, from Clinical Commissioning Groups and other trusted NHS sources, to doctors, nurses and pharmacists in their workflow and during the patient consultation. This effective clinical decision support ultimately translates to improved healthcare outcomes delivered more cost effectively and which should significantly contribute towards the NHS achieving its projected efficiency savings.

Attachment

• DXS Notification of Director PDMR Dealings_11 11 2025 Bob Sutcliffe

My Grief Angels Inc Launches the “Holidays Grief Support Care Package” to Aid Those Mourning During the Holiday Season




My Grief Angels Inc Launches the “Holidays Grief Support Care Package” to Aid Those Mourning During the Holiday Season

Innovative free online resources aim to provide comfort and support for individuals grieving the loss of loved ones during the holidays.

New York, NY, Nov. 11, 2025 (GLOBE NEWSWIRE) — My Grief Angels Inc, a renowned non-profit organization dedicated to supporting individuals coping with loss, has announced the launch of its new “Holidays Grief Support Care Package.” This initiative is designed to assist those mourning the death of loved ones during the holiday season, a time often marked by joy and celebration but which can be particularly challenging for those experiencing grief.

Holidays Grief Support Care Package

The “Holidays Grief Support Care Package” has its own dedicated website at HolidaysGrief.com and offers a comprehensive set of tools aimed at providing comfort and understanding. It includes educational videos featuring volunteers who have experienced the loss of children, spouses, parents, and others. These heartfelt stories share personal grief journeys and the challenges faced during the first holidays after their loss, offering insights and solace to those in similar situations.

The videos address various emotional hurdles encountered during the holiday season. Participants have expressed sentiments such as the discomfort of seeing joyful holiday commercials or the struggle of maintaining a facade of happiness while feeling profound sorrow. One volunteer noted, “Every morning walking into a workplace full of holiday decorations and colleagues talking about what they are planning to make for their Thanksgiving dinner gathering, I smile but I am screaming inside.” Such candid reflections highlight the reality many face during this time.

To enhance accessibility, these educational videos have been converted into podcasts, allowing individuals to listen to them on-the-go, whether in their cars, on the subway, or while traveling by plane. This flexibility ensures that support is available whenever and wherever it is needed.

The care package dedicated website also provides links to free open virtual peer-led grief support groups at 8:00 PM (EST) on each of the upcoming major holidays: Thanksgiving Day; Christmas Day, and New Year’s Eve. Each of the virtual gatherings offers the option for participants to select and view closed captions of the live meeting in their language of choice.

Additionally, the care package includes a new multilingual Massive Open Online Course (MOOC) titled “Holidays Grief: What is it and How Do We Get Through it?” This course is available in multiple languages, including Spanish, French, Portuguese, Hindi, Arabic, Hebrew, and Chinese, broadening its reach and impact. This initiative builds on My Grief Angels’ pioneering work with their first and most popular Grief MOOC, “How Grief Can Kill or Empower Us?”

An online chat channel, “Holidays Grief: How do we get through it?”, has also been established on the non-profit’s free online Grief Chat Community at Chat.MyGriefAngels.org. This platform provides a space for individuals to connect, share experiences, and support one another during this difficult time of year.

“The holidays often bring emotional challenges for those coping with grief,” noted Augusto Failde, Chief Learning Officer at My Grief Angels Inc. “With the Holidays Grief Support Package, we’re harnessing technology to deliver comfort and community directly to people’s cell phones — free, immediate access to resources that remind them they are not alone.”

My Grief Angels Inc continues to leverage new scalable technologies and community-driven initiatives to support individuals worldwide, reaffirming its commitment to providing accessible and meaningful grief support to anyone, anywhere and at any time.

Holidays Grief Support Video Cards

About My Grief Angels Inc

Recognized by BetterHelp.com as “One of the Best Online Grief Support Groups” (August 2022), My Grief Angels Inc. is a 501(c)(3) public charity providing free, technology-driven online grief support worldwide. Its services include weekly peer-led virtual groups by type of loss, “Grieving @ Holidays” sessions on major holidays, and free access to UGrief: University of Grief (UGrief.com) – the largest collection of online grief courses. My Grief Angels also offers an online chat community and digital resources. The organization holds both the Top-Rated GreatNonprofits Seal and Candid Platinum Seal for excellence and transparency. 

Press inquiries

My Grief Angels Inc
https://www.mygriefangels.org/
Paul Carbonell
media@MyGriefAngels.com
4438508033
MyGriefAngels.org

A video accompanying this announcement is available at https://www.youtube.com/embed/TxwlfGJZHj0

My Grief Angels Inc Launches the “Holidays Grief Support Care Package” to Aid Those Mourning During the Holiday Season




My Grief Angels Inc Launches the “Holidays Grief Support Care Package” to Aid Those Mourning During the Holiday Season

Innovative free online resources aim to provide comfort and support for individuals grieving the loss of loved ones during the holidays.

New York, NY, Nov. 11, 2025 (GLOBE NEWSWIRE) — My Grief Angels Inc, a renowned non-profit organization dedicated to supporting individuals coping with loss, has announced the launch of its new “Holidays Grief Support Care Package.” This initiative is designed to assist those mourning the death of loved ones during the holiday season, a time often marked by joy and celebration but which can be particularly challenging for those experiencing grief.

Holidays Grief Support Care Package

The “Holidays Grief Support Care Package” has its own dedicated website at HolidaysGrief.com and offers a comprehensive set of tools aimed at providing comfort and understanding. It includes educational videos featuring volunteers who have experienced the loss of children, spouses, parents, and others. These heartfelt stories share personal grief journeys and the challenges faced during the first holidays after their loss, offering insights and solace to those in similar situations.

The videos address various emotional hurdles encountered during the holiday season. Participants have expressed sentiments such as the discomfort of seeing joyful holiday commercials or the struggle of maintaining a facade of happiness while feeling profound sorrow. One volunteer noted, “Every morning walking into a workplace full of holiday decorations and colleagues talking about what they are planning to make for their Thanksgiving dinner gathering, I smile but I am screaming inside.” Such candid reflections highlight the reality many face during this time.

To enhance accessibility, these educational videos have been converted into podcasts, allowing individuals to listen to them on-the-go, whether in their cars, on the subway, or while traveling by plane. This flexibility ensures that support is available whenever and wherever it is needed.

The care package dedicated website also provides links to free open virtual peer-led grief support groups at 8:00 PM (EST) on each of the upcoming major holidays: Thanksgiving Day; Christmas Day, and New Year’s Eve. Each of the virtual gatherings offers the option for participants to select and view closed captions of the live meeting in their language of choice.

Additionally, the care package includes a new multilingual Massive Open Online Course (MOOC) titled “Holidays Grief: What is it and How Do We Get Through it?” This course is available in multiple languages, including Spanish, French, Portuguese, Hindi, Arabic, Hebrew, and Chinese, broadening its reach and impact. This initiative builds on My Grief Angels’ pioneering work with their first and most popular Grief MOOC, “How Grief Can Kill or Empower Us?”

An online chat channel, “Holidays Grief: How do we get through it?”, has also been established on the non-profit’s free online Grief Chat Community at Chat.MyGriefAngels.org. This platform provides a space for individuals to connect, share experiences, and support one another during this difficult time of year.

“The holidays often bring emotional challenges for those coping with grief,” noted Augusto Failde, Chief Learning Officer at My Grief Angels Inc. “With the Holidays Grief Support Package, we’re harnessing technology to deliver comfort and community directly to people’s cell phones — free, immediate access to resources that remind them they are not alone.”

My Grief Angels Inc continues to leverage new scalable technologies and community-driven initiatives to support individuals worldwide, reaffirming its commitment to providing accessible and meaningful grief support to anyone, anywhere and at any time.

Holidays Grief Support Video Cards

About My Grief Angels Inc

Recognized by BetterHelp.com as “One of the Best Online Grief Support Groups” (August 2022), My Grief Angels Inc. is a 501(c)(3) public charity providing free, technology-driven online grief support worldwide. Its services include weekly peer-led virtual groups by type of loss, “Grieving @ Holidays” sessions on major holidays, and free access to UGrief: University of Grief (UGrief.com) – the largest collection of online grief courses. My Grief Angels also offers an online chat community and digital resources. The organization holds both the Top-Rated GreatNonprofits Seal and Candid Platinum Seal for excellence and transparency. 

Press inquiries

My Grief Angels Inc
https://www.mygriefangels.org/
Paul Carbonell
media@MyGriefAngels.com
4438508033
MyGriefAngels.org

A video accompanying this announcement is available at https://www.youtube.com/embed/TxwlfGJZHj0