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Cadrenal Therapeutics to Participate in the Lytham Partners Fall 2025 Investor Conference on September 30, 2025

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Cadrenal Therapeutics to Participate in the Lytham Partners Fall 2025 Investor Conference on September 30, 2025




Cadrenal Therapeutics to Participate in the Lytham Partners Fall 2025 Investor Conference on September 30, 2025

PONTE VEDRA, Fla., Sept. 29, 2025 (GLOBE NEWSWIRE) — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company developing transformative therapeutics to overcome the gaps in anticoagulation therapy, today announced that it will participate in a webcast presentation and host one-on-one meetings with investors at the Lytham Partners Fall 2025 Investor Conference, taking place virtually on Tuesday, September 30, 2025.

Company Webcast

The webcast presentation will take place at 3:30 p.m. ET on Tuesday, September 30, 2025. The webcast can be accessed by visiting the conference home page at https://lythampartners.com/fall2025/ or directly at https://app.webinar.net/QG1g6kJWEM0. The webcast will also be available for replay following the event.

1×1 Meetings

Management will be participating in virtual one-on-one meetings throughout the event. To arrange a meeting with management, please contact Lytham Partners at 1×1@lythampartners.com or register for the event at https://lythampartners.com/fall2025invreg/.

About Cadrenal Therapeutics, Inc.
Cadrenal Therapeutics, Inc. is a biopharmaceutical company developing transformative therapeutics to overcome the gaps in anticoagulation therapy. Cadrenal’s lead investigational product is tecarfarin, a novel oral Vitamin K antagonist anticoagulant that is designed to address unmet needs in anticoagulation therapy. Tecarfarin is a reversible anticoagulant (blood thinner) designed to prevent heart attacks, strokes, and deaths due to blood clots in patients requiring chronic anticoagulation. Although warfarin is widely used, extensive clinical and real-world data have shown it can have significant, serious side effects. With tecarfarin, Cadrenal aims to reduce the clinical complexities of managing Vitamin K antagonists, particularly where direct-acting oral anticoagulants (DOACs) remain inadequate or unproven.

Tecarfarin received Orphan Drug Designation (ODD) and fast-track designation for the prevention of systemic thromboembolism (blood clots) of cardiac origin in patients with end-stage kidney disease and atrial fibrillation (ESKD+AFib). The Company also received ODD for the prevention of thromboembolism and thrombosis in patients with implanted mechanical circulatory support devices, including Left Ventricular Assist Devices (LVADs).

For more information, visit https://www.cadrenal.com/ and connect with the Company on LinkedIn.

For more information, please contact:

Cadrenal Therapeutics:
Matthew Szot, CFO
press@cadrenal.com

Investors:
Lytham Partners, LLC
Robert Blum, Managing Partner
602-889-9700
CVKD@lythampartners.com

MAIA Biotechnology Announces $2.25 Million Private Placement

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MAIA Biotechnology Announces $2.25 Million Private Placement




MAIA Biotechnology Announces $2.25 Million Private Placement

CHICAGO, IL, Sept. 29, 2025 (GLOBE NEWSWIRE) — MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced that it has entered into definitive agreements for the purchase and sale of an aggregate of 1,733,766 shares of common stock at a purchase price of $1.30 per share, in a private placement to accredited investors and a Company director. Each share of common stock is being offered together with a warrant to purchase one share of common stock at an exercise price of $1.57 per share, which price represents the “Minimum Price” as defined under NYSE American Rule 713 (subject to customary adjustments as set forth in the warrants). The warrants are exercisable commencing six-months following issuance and have a term of three years from the issuance date. The securities being sold to the Company director participating in the offering are being issued pursuant to the Company’s 2021 Equity Incentive Plan. The private placement is expected to close on or about October 1, 2025, subject to the satisfaction of customary closing conditions.

The gross proceeds from the offering are expected to be approximately $2.25 million, prior to offering expenses payable by the Company. The Company intends to use the net proceeds from the offering for to fund the execution of Step 1 of Part C of the Phase II trial THIO -101 and for working capital.

The securities described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), and/or Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other 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 other jurisdiction.

About MAIA Biotechnology, Inc.

MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is ateganosine (THIO), a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.

Forward Looking Statements

MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) completion of the private placement, (ii) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (iii) our ability to advance product candidates into, and successfully complete, clinical studies, (iv) the timing or likelihood of regulatory filings and approvals, (v) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (vi) the rate and degree of market acceptance of our product candidates, (vii) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (viii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.

Investor Relations Contact
+1 (872) 270-3518
ir@maiabiotech.com

MAIA Biotechnology Announces $2.25 Million Private Placement

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MAIA Biotechnology Announces $2.25 Million Private Placement




MAIA Biotechnology Announces $2.25 Million Private Placement

CHICAGO, IL, Sept. 29, 2025 (GLOBE NEWSWIRE) — MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced that it has entered into definitive agreements for the purchase and sale of an aggregate of 1,733,766 shares of common stock at a purchase price of $1.30 per share, in a private placement to accredited investors and a Company director. Each share of common stock is being offered together with a warrant to purchase one share of common stock at an exercise price of $1.57 per share, which price represents the “Minimum Price” as defined under NYSE American Rule 713 (subject to customary adjustments as set forth in the warrants). The warrants are exercisable commencing six-months following issuance and have a term of three years from the issuance date. The securities being sold to the Company director participating in the offering are being issued pursuant to the Company’s 2021 Equity Incentive Plan. The private placement is expected to close on or about October 1, 2025, subject to the satisfaction of customary closing conditions.

The gross proceeds from the offering are expected to be approximately $2.25 million, prior to offering expenses payable by the Company. The Company intends to use the net proceeds from the offering for to fund the execution of Step 1 of Part C of the Phase II trial THIO -101 and for working capital.

The securities described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), and/or Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other 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 other jurisdiction.

About MAIA Biotechnology, Inc.

MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is ateganosine (THIO), a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.

Forward Looking Statements

MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) completion of the private placement, (ii) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (iii) our ability to advance product candidates into, and successfully complete, clinical studies, (iv) the timing or likelihood of regulatory filings and approvals, (v) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (vi) the rate and degree of market acceptance of our product candidates, (vii) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (viii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.

Investor Relations Contact
+1 (872) 270-3518
ir@maiabiotech.com

DINAMIQS opens cGMP manufacturing facility for viral vectors

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Media Release
Zofingen, September 29, 2025

DINAMIQS, a Siegfried company (SIX: SFZN), today inaugurated its state-of-the-art cGMP manufacturing facility for viral vectors — the first of its kind in Switzerland. The new facility enables end-to-end manufacturing of viral vector gene therapies, from molecule design to aseptic drug product filling. As part of this facility, new lab space has already been operational since Q3 2024. With this milestone, Siegfried strengthens its footprint in the rapidly growing cell and gene therapy market. To mark the inauguration, DINAMIQS also announced a strategic collaboration with SEAL Therapeutics to support the development and manufacturing of a gene therapy for a severe muscular dystrophy.

Marcel Imwinkelried, Chief Executive Officer Siegfried: “Since acquiring the startup in 2023, Siegfried’s ambition has been to bring DINAMIQS’ capabilities to commercial scale and establish it as a leading CDMO in the cell and gene therapy space. With the opening of the new manufacturing facility and growing customer demand, we are well on track to achieving this goal.”

Located in the Bio-Technopark in Zurich, DINAMIQS’ new 2,500m² cGMP facility brings R&D, clinical and commercial viral vector manufacturing under one roof, with production capacity up to 1,000L scale. Featuring a modular, segregated design and state-of-the-art closed, single-use technologies, it ensures strict containment, fast turnaround times, and full GMP compliance.

Martin Kessler, Chief Executive Officer DINAMIQS: “One of the biggest challenges that cell and gene therapy developers face today is scalability in process development and manufacturing. With the design of our facilities in Zurich, we enable our customers to get everything they need from one partner and one location. We offer lead optimization, R&D production and now also clinical and commercial supply – saving customers time and money when bringing their therapies to patients.”

In connection with the facility inauguration, DINAMIQS and SEAL Therapeutics announced the intention to enter a strategic collaboration. SEAL Therapeutics, a spin-off from the Biozentrum of the University of Basel, is developing an innovative gene therapy designed to address the functional defects that cause LAMA2 related muscular dystrophy, a severe childhood-onset disease characterized by progressive muscle loss and with no current treatment option. The research team led by Professor Dr. Markus Rüegg, Dr. Judith Reinhard and Dr. Thomas Meier will be supported by DINAMIQS experts to scale up production of their innovative gene therapy, enabling the transition from laboratory research toward potential patient treatment.

Markus Rüegg, Chief Executive Officer of SEAL Therapeutics: “To advance our viral vector-based gene therapy toward clinical application, we chose DINAMIQS for their specific expertise with the vector we require, their large-scale production capabilities, and their collaborative approach as a trusted Swiss-based partner.”

African Leaders Call for Bold, United Action to Tackle Global Health Crises and Sustain Malaria Progress

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African Leaders Malaria Alliance (ALMA)

/ Key word(s): Miscellaneous

African Leaders Call for Bold, United Action to Tackle Global Health Crises and Sustain Malaria Progress

26.09.2025 / 13:15 CET/CEST

The issuer is solely responsible for the content of this announcement.

NEW YORK, United States of America, September 26, 2025/APO Group/ — African Heads of State and Government convened global leaders on Wednesday at a high-level event on the margins of the 80th United Nations General Assembly, sounding the alarm on escalating threats to global health security.

Convened under the theme “Uniting for Global Health Security”, the joint event brought together the Global Leaders Network for Women’s, Children’s and Adolescents’ Health, chaired by H.E. President Cyril Ramaphosa of South Africa, and the African Leaders Malaria Alliance (ALMA), chaired by President Advocate Duma Gideon Boko of Botswana. Discussions were moderated by the Rt Hon. Helen Clark, chair of the Partnership for Maternal, Newborn, and Child Health and former prime minister of New Zealand.

Amid growing concern over stagnating progress toward the Sustainable Development Goals for health, leaders called for urgent financial commitments, stronger partnerships, and bold, united action to protect the world’s most vulnerable, including women, children, and adolescents, from preventable diseases such as malaria.

“The fight against malaria is becoming increasingly complex,” said President Advocate Duma Gideon Boko. “Shrinking budgets, rising biological resistance, humanitarian crises, and the impact of climate change are all contributing towards creating a perfect storm of challenges,” he added.

Funding declines threaten progress

Recent years have seen a dramatic erosion of official development assistance (ODA) for health, with African leaders warning that life-saving programmes risk collapse in the absence of urgent and sustained financing. Between 2021 and 2025 alone, ODA for health in Africa declined by an estimated 70%, even as widening equity gaps, conflict, and displacement have expanded both needs and vulnerability.

H.E. President Cyril Ramaphosa highlighted the impact of these cuts, “essential programmes to eliminate malaria have been compromised. This leaves millions without care and erodes decades of progress that has been made so far.”

A successful Global Fund Replenishment is vital

Leaders reiterated support for the upcoming 8th replenishment of the Global Fund to Fight AIDS, Tuberculosis and Malaria, which aims to raise US$18 billion at its November 2025 conference. The Global Fund, established in 2002, has been central to progress against the three diseases, saving more than 70 million lives. Leaders stressed that the upcoming replenishment is critical, not only to sustain momentum but also to prevent a reversal of hard-won gains amid rising threats.

The ALMA chair issued a rallying call on the upcoming replenishment, “I call on all countries and donors to invest boldly in the Global Fund replenishment. If we all come together, we will save 23 million lives from malaria, AIDS and TB, while strengthening our health systems.”

Strengthening national ownership, innovative resource mobilisation and local manufacturing

While underscoring the importance of global solidarity, the African leaders noted that African ownership and accountability must be at the centre of the response, with H.E. President William Ruto of the Republic of Kenya saying “the future of Africa health financing lies in our own hands. Encouragingly, across the continent, change is already underway.”

Through initiatives like national End Malaria Councils and Funds, countries are embracing innovative financing approaches to expand the pool of resources for malaria, with 11 African countries already having mobilised over US$166 million, illustrating the power of multi-sectoral collaboration. 

At the same time, African leaders recommended tried and tested innovations, calling for the World Bank’s International Development Association (IDA) to set up a 2nd Malaria Booster Programme. The first malaria booster program (phase I and phase II) between 2005 and 2015 saw millions invested in malaria control and millions of cases prevented and lives saved. This vital programme helped “reinforce local health systems, such as community health workers, and enhance data systems and surveillance” said H.E. Muhammed B.S Jallow, vice president of the Republic of The Gambia.

With the recent IDA21 replenishment, there’s an opportunity to deliver a similar programme to address the challenges we face today, with the ALMA chair, President Advocate Duma Gideon Boko saying, “as ALMA, we are calling on the World Bank International Development Association to establish a second Malaria Booster Programme.” he said.

A push for national ownership was made by Dr Sania Nishtar, CEO of GAVI, who said “we strongly believe countries and not global health institutions should be at the centre of global health.” Dr Nishtar highlighted GAVI’s African Vaccine Manufacturing Accelerator which she said “promotes African self-reliance in vaccine manufacturing.” The GAVI CEO also shared that the vaccine alliance is “implementing the fastest vaccine rollout in Gavi’s 25-year history” with the introduction of malaria vaccines across 23 African countries, with early evidence showing a 13% drop in all-cause child mortality in vaccinated areas.

The need for public-private partnerships to deliver sustainable financing

Leaders called for the establishment of a Public-Private Partnership Health Accelerator to respond to declining traditional funding, with President Advocate Duma Gideon Boko encouraging fellow leaders to “think bigger and cast our net wider to mobilise even more resources to respond to the critical health challenges.”

This partnership will deliver new investments and drive progress toward universal health coverage. The accelerator is expected to leverage partnerships with the private sector, philanthropic foundations, high networth individuals and the diaspora, whilst reinforcing domestic commitments.

“We need a private-public partnership health accelerator that will drive whole-of-society progress towards the SDGs through sustainable high-value investments,” shared the ALMA chair.

This call for public private partnerships was endorsed by fellow leaders, with the vice president of the Republic of the Gambia saying these partnerships “can help us deliver sustainable financing at this critical moment and lead our continent to prosperity.”

The Big Push against Malaria

Earlier this year, the Africa Centre for Disease Control and Prevention (Africa CDC) unveiled a bold strategy to transform health financing across the continent amidst the volatile and ever-evolving global financing landscape. This momentum was amplified in Abuja with the launch of the “Big Push” to End Malaria in early September, placing malaria elimination at the heart of Africa’s health and development agenda. Building on this, African leaders at the UN General Assembly called for a paradigm shift in investments to sustain the fight against malaria and broader health challenges across the continent.

The joint event signalled renewed determination to confront overlapping crises with urgency, innovation, and unity, with H.E Dr Jean Kaseya, Director General of the Africa-Centres for Disease Control and Prevention, urging leaders to continue to turn these crises into opportunities to “start to raise sustainable financing, to build our own data system owned by the continent, to start to manufacture our own vaccines, medicines, and to build strong surveillance system. Now Africa is leading the world.”

As African countries moves towards greater ownership of our health systems and development agenda, Professor Senait Fisseha, a champion of sexual and reproductive health rights encouraged leaders to “to ensure it reflect our values, what we believe and is right, and is needed for our people” so that “we can create a continent in which every woman, every girl, every child can live to her fullest potential.”

“Together, let us rise to this moment. Let us prove that resilient health systems are the cornerstone of dignity, security and prosperity,” said H.E. President William Ruto of the Republic of Kenya at the conclusion of his remarks, echoing ALMA chair, President Advocate Duma Gideon Boko who said “we can make malaria elimination a reality. We can deliver a healthy tomorrow for women, babies, children and adolescents. The time to start is now.”

Distributed by APO Group on behalf of African Leaders Malaria Alliance (ALMA).

Download image: https://apo-opa.co/4gLjJ2s

Image Caption: L-R : H.E. President Advocate Duma Gideon Boko of Botswana, Chair of the African Leaders Malaria Alliance; H.E. President Cyril Ramaphosa of South Africa and Chair of the Global Leaders Network; H.E. President William Ruto of Kenya ;and the Rt. Hon. Helen Clark at the UNGA80 side-event on Global Health Security at the United Nations

 

26.09.2025 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group.
The issuer is solely responsible for the content of this announcement.

The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Archive at www.eqs-news.com

2204474  26.09.2025 CET/CEST

Pentixapharm Announces Advancement of PentixaTher to Fourth Dose Level in Acute Myeloid Leukemia Trial

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Pentixapharm Holding AG

/ Key word(s): Study/Research Update

Pentixapharm Announces Advancement of PentixaTher to Fourth Dose Level in Acute Myeloid Leukemia Trial (news with additional features)

26.09.2025 / 08:00 CET/CEST

The issuer is solely responsible for the content of this announcement.

 Achieves Key Milestone with CXCR4-based Radiotherapeutic

  • Favorable safety profile enables advancement of radiolabeled PentixaTher to fourth of five planned activity dose levels in investigator-initiated PENTILULA Phase 1/2 trial
  • Milestone marks important step for novel radiotherapeutic candidate in high unmet need indication with limited treatment options and poor prognosis

 Berlin, Germany, September 26, 2025 – Pentixapharm AG (Frankfurt Prime Standard: PTP), an advanced clinical-stage biotech, developing novel radiopharmaceuticals, today announced that its CXCR4-targeting radiolabeled candidate PentixaTher has advanced to the fourth dose level in the investigator-initiated PENTILULA Phase 1/2 study in acute myeloid leukemia (AML).

Based on favorable safety findings at the third dose level of 7.5 GBq, the investigator-initiated trial received approval from the independent Data Safety Monitoring Board (DSMB) to advance to the fourth of five planned dose levels at 10 GBq, underscoring PentixaTher’s tolerability to date. Importantly, this advancement not only reinforces the compound’s safety profile but also moves the study into a dose range with a higher likelihood for meaningful clinical efficacy. If favorable safety signals continue, the study is expected to escalate to a fifth and final dose level of 12.5 GBq.

AML is the most common acute leukemia in adults, with approximately 20,000 new cases annually in the U.S. and 17,000 new cases annually in Europe. Five-year survival rates range between approximately 32 and 37%, respectively.

“Advancing to higher dose levels marks a key step in validating the therapeutic potential and promise of PentixaTher,” said Dirk Pleimes, MD, CEO/CMO of Pentixapharm. “The encouraging results in this investor-led effort highlight the potential of CXCR4 as a powerful target for hematologic cancers and demonstrate the promise of radiopharmaceuticals to expand treatment options where medical need is greatest. The trial is expanding the clinical evidence base for CXCR4-targeted therapy to expand the boundaries of radiopharmaceuticals.”

Professor Françoise Kraeber-Bodéré, Nuclear Medicine Department, CHU Nantes, Principal Investigator, commented: “We are encouraged by the favorable safety profile observed to date, which has enabled us to move to higher activity dose levels. At dose level four, we are now entering a range considered of potentially higher effectiveness, and we look forward to evaluating the clinical impact in this high-need patient population.”

Professor Patrice Chevallier, Hematology Department, CHU Nantes added: “For patients with advanced AML, treatment options are limited, and prognosis in this often heavily pretreated population is poor. Reaching this dose level with an acceptable safety profile provides new hope that CXCR4-targeted radiopharmaceuticals could one day become a meaningful addition to the therapeutic landscape.”

  

About PentixaTher and the PENTILULA Phase 1/2 Study

Radiolabeled PentixaTher is a novel radiotherapeutic designed to selectively target the chemokine receptor CXCR4, a key player in the bone marrow microenvironment that is frequently overexpressed in aggressive hematological malignancies. The compound is labeled for the PENTILULA study with 177-lutetium, a clinically well-established isotope, enabling precise delivery of a targeted radiation payload. PentixaTher is currently being evaluated in the PENTILULA Phase 1/2 study (ClinicalTrials.gov ID: NCT06356922), initiated in November 2024. The multicenter, open-label, dose-escalation trial is led by an experienced investigator team at the University Hospital of Nantes and conducted at three additional clinical sites in France. It aims primarily to assess the safety and tolerability of PentixaTher, with secondary objectives including preliminary measures of clinical activity such as overall response rate, complete response rate, and overall survival. The study is supported by the French Ministry of Health.

 

About Pentixapharm

Pentixapharm is an advanced clinical-stage biotech expanding the boundaries of radiopharmaceuticals. Headquartered in Berlin, Germany, the company develops first-in-class ligand- and antibody-based radiopharmaceuticals designed to transform patient care across oncology and beyond. Its late-stage pipeline is anchored by CXCR4-targeted programs, including a Phase 3-ready diagnostic candidate for primary aldosteronism and pioneering therapeutic programs in a number of hematological and solid cancers. Furthermore, Pentixapharm is advancing a next-generation antibody platform targeting CD24, an emerging immune-escape marker over-expressed in multiple hard-to-treat cancers. Complemented by reliable isotope supply from Eckert & Ziegler, and a robust global clinical network, Pentixapharm is uniquely positioned to deliver innovative radiopharmaceuticals that address high unmet need, improve patient outcomes, and create significant growth opportunities in one of the fastest-growing areas of precision medicine.

 

About Nantes University Hospital

Nantes University Hospital (CHU de Nantes) is one of France’s leading healthcare institutions, recognized for its excellence in various medical specialties including cardiology, transplants, oncology, and neuroscience. The hospital is also a key player in medical research and innovation, conducting clinical trials and contributing to significant advancements in healthcare, in particular in nuclear medicine and hematology. [177Lu]Lu-PentixaTher is produced by ARRONAX, the hospital radiopharmacy unit (APUI), which is specially authorized for the preparation of the radiopharmaceutical investigational product.

 

Pentixapharm Investor and Media Contact

ir@pentixapharm.com

Additional features:

File: 20250925 – Pentixapharm PR IIT Nantes EN FINAL

26.09.2025 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group.
The issuer is solely responsible for the content of this announcement.

The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Archive at www.eqs-news.com
Language: English
Company: Pentixapharm Holding AG
Robert-Rössle-Straße 10
13125 Berlin
Germany
E-mail: info@pentixapharm.com
Internet: https://www.pentixapharm.com/
ISIN: DE000A40AEG0
WKN: A40AEG
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Hanover, Munich, Stuttgart, Tradegate Exchange
EQS News ID: 2203960

 
End of News EQS News Service

2203960  26.09.2025 CET/CEST

Change in the Chairmanship of the Board of Directors

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Media Release
Zofingen, September 26, 2025

Ad hoc announcement pursuant to Art. 53 Listing Rules

Dr. Andreas Casutt (1963) has been a member of the Board of Directors of Siegfried Holding AG (SIX: SFZN) since 2010 and its Chairman since 2014. The attorney and partner at the Zurich law firm Niederer Kraft Frey AG has decided not to stand for re-election at the Annual General Meeting on April 16, 2026. 

Andreas Casutt, Chairman of the Board of Directors: “Even after 16 years on Siegfried’s Board of Directors, this decision is not an easy one for me. But the timing for a change in the chairmanship is right. Siegfried is best positioned today to continue its successful journey of growth.”  

Martin Schmid, Vice Chairman of the Board of Directors: “Andreas has significantly shaped our company over the past years. Under his leadership, Siegfried developed into a successful, global CDMO. His personal contribution to Siegfried’s ongoing success is substantial.”

The Board of Directors will propose to the 2026 Annual General Meeting that Dr. Beat Walti (1968) be elected the new Chairman of the Board of Directors. Beat Walti was elected to the Board of Directors of Siegfried Holding in 2022. The attorney chairs the Board of Trustees of the Ernst Göhner Foundation, Siegfried’s largest shareholder, holds board mandates at the Danish company DSV A/S and, as Chairman, at the Zurich-based trading company Rahn AG. In addition, he has been a member of the Swiss National Council since 2014, where he serves on the Economic Affairs and Taxation Committee.

Andreas Casutt: “Beat has many years of experience on the governing bodies of companies and foundations in Switzerland as well as internationally. In recent years, he has made significant contributions to Siegfried’s development as a member of our Board of Directors. Together with the Board and the Executive Committee, he will actively drive forward the expansion of our company’s market position in the years ahead.”

Heidelberg Pharma Advances to Cohort 9 in Phase I/IIa Trial of Lead ATAC Candidate HDP-101 in Multiple Myeloma

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Heidelberg Pharma AG

/ Key word(s): Study results

Heidelberg Pharma Advances to Cohort 9 in Phase I/IIa Trial of Lead ATAC Candidate HDP-101 in Multiple Myeloma

25.09.2025 / 13:17 CET/CEST

The issuer is solely responsible for the content of this announcement.

PRESS RELEASE

Heidelberg Pharma Advances to Cohort 9 in Phase I/IIa Trial of Lead ATAC Candidate HDP-101 in Multiple Myeloma

  • HDP-101 continues to demonstrate a favorable safety profile with no dose-limiting toxicities observed
  • Early evidence of clinical activity observed in Cohort 8, highlighted by a very good partial response observed in one patient

Ladenburg, Germany, 25 September 2025 – Heidelberg Pharma AG (FSE: HPHA), a clinical-stage biotech company developing innovative Antibody Drug Conjugates (ADCs), today announced the initiation of Cohort 9 in its ongoing Phase I/IIa dose escalation trial of HDP-101, the Company’s lead ATAC candidate for the treatment of relapsed or refractory multiple myeloma.

The Safety Review Committee (SRC) has confirmed that the 140 µg/kg dose level administered in Cohort 8 was safe and well tolerated. Based on these findings, the study is now progressing into Cohort 9 with an escalated dose of 175 µg/kg, administered in one dosing arm. Cohort 9 has already opened.

Eight patients were dosed in Cohort 8 and all patients completed the observation period, demonstrated a favorable safety and tolerability profile throughout. Encouraging signs of clinical activity have also emerged. Patients showed biological activity of HDP-101, and a very good partial response has already been observed in one patient. This adds to earlier positive outcomes, including one patient from Cohort 5 who is still on treatment and achieved complete remission, with no detectable tumor cells after ongoing HDP-101 monotherapy following multiple prior treatments. In addition, several patients across different cohorts have shown objective responses and promising anti-tumor activity, further supporting the therapeutic potential of HDP-101 in heavily pretreated patients with relapsed or refractory multiple myeloma.

Dr. András Strassz, Chief Medical Officer at Heidelberg Pharma, said: “Our lead ATAC candidate HDP-101 continues to demonstrate a strong safety and tolerability profile across all treated patients. The results from Cohort 8 demonstrate encouraging signs of clinical activity of HDP-101, including a very good partial response in one patient. These early efficacy signals are promising as we advance HDP-101 through the ongoing dose escalation study.”

Heidelberg Pharma’s Phase I/IIa clinical study is a non-randomized, open-label trial actively enrolling patients with relapsed or refractory multiple myeloma or other BCMA-expressing plasma cell disorders. The study is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of HDP-101 in this patient population.

About Heidelberg Pharma

Heidelberg Pharma is a biopharmaceutical company working on a new treatment approach in oncology and developing novel drugs based on its ADC technologies for the targeted and highly effective treatment of cancer. ADCs are antibody-drug conjugates that combine the specificity of antibodies with the efficacy of toxins to fight cancer. Selected antibodies are loaded with cytotoxic compounds, the so-called payloads, that are transported into diseased cells. Inside the cells, the toxins then unleash their effect and kill the diseased cells.

Heidelberg Pharma is the first company to use the compound Amanitin from the green death cap mushroom in cancer therapy. The biological mechanism of action of the toxin represents a new therapeutic modality and is used as a compound in the Amanitin-based ADC technology, the so-called ATAC technology.

The lead candidate HDP-101 is a BCMA ATAC in clinical development for multiple myeloma. A second ATAC candidate, HDP-102, has recently started clinical development in Non-Hodgkin Lymphoma. HDP-103 against metastatic castration-resistant prostate cancer and HDP-104 targeting gastrointestinal tumors such as colorectal cancer have completed preclinical development. Heidelberg Pharma is open for partnering.

The company is based in Ladenburg, Germany, and is listed on the Frankfurt Stock Exchange: ISIN DE000A11QVV0 / WKN A11QVV / Symbol HPHA. More information is available at www.heidelberg-pharma.com

ATAC® is a registered trademark of Heidelberg Pharma Research GmbH.

ITAC™, ETAC™ are pending trademark applications of Heidelberg Pharma Research GmbH.

Contact
Heidelberg Pharma AG
Sylvia Wimmer
Director Corporate Communications
Tel.: +49 89 41 31 38-29
E-Mail: investors@hdpharma.com
Gregor-Mendel-Str. 22, 68526 Ladenburg		  
IR/PR-Support
MC Services AG
Katja Arnold (CIRO)
Managing Director & Partner
Tel.: +49 89 210 228-40
E-Mail: katja.arnold@mc-services.eu
International IR/PR-Support
Optimum Strategic Communications
Mary Clark, Zoe Bolt, Aoife Minihan
Tel: +44 20 3882 9621
Email: HeidelbergPharma@optimumcomms.com
 

This communication contains certain forward-looking statements relating to the Company’s business, which can be identified by the use of forward-looking terminology such as “estimates”, “believes”, “expects”, “may”, “will” “should” “future”, “potential” or similar expressions or by a general discussion of the Company’s strategy, plans or intentions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause our actual results of operations, financial condition, performance, or achievements, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Given these uncertainties, prospective investors and partners are cautioned not to place undue reliance on such forward-looking statements. We disclaim any obligation to update any such forward-looking statements to reflect future events or developments.

25.09.2025 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group.
The issuer is solely responsible for the content of this announcement.

The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
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Language: English
Company: Heidelberg Pharma AG
Gregor-Mendel-Str. 22
68526 Ladenburg
Germany
Phone: +49 (0)89 41 31 38 – 0
Fax: +49 (0)89 41 31 38 – 99
E-mail: investors@hdpharma.com
Internet: www.heidelberg-pharma.com
ISIN: DE000A11QVV0
WKN: A11QVV
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Munich, Stuttgart, Tradegate Exchange
EQS News ID: 2203868

 
End of News EQS News Service

2203868  25.09.2025 CET/CEST

Carlsmed, Inc. Appoints Jennifer Kamocsay as Chief Legal Officer and Secretary

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Carlsmed, Inc. Appoints Jennifer Kamocsay as Chief Legal Officer and Secretary




Carlsmed, Inc. Appoints Jennifer Kamocsay as Chief Legal Officer and Secretary

CARLSBAD, Calif., Sept. 29, 2025 (GLOBE NEWSWIRE) — Carlsmed, Inc. (Nasdaq: CARL) (“Carlsmed” or the “Company”), a medical technology company pioneering AI-enabled personalized spine surgery solutions, today announced the appointment of Jenifer Kamocsay as Chief Legal Officer and Secretary, effective immediately. Ms. Kamocsay will serve as legal counsel for the Company and oversee compliance and corporate governance.

Ms. Kamocsay brings more than two decades of corporate legal experience as in-house counsel across life science and technology sectors at Akoya Biosicences, Rubius Therapeutics, Inc. and Progress Software Corporation.

“We are pleased to welcome Jennifer to the Carlsmed leadership team as we strengthen our organization and strategically expand our leadership team following our IPO,” said Mike Cordonnier, Chairman and CEO of Carlsmed. “Her deep expertise in corporate governance, securities law and broader legal strategy will be instrumental as we continue to scale our business and prepare for our cervical commercial launch.”

Prior to Akoya, Ms. Kamocsay served as General Counsel and Corporate Secretary of Rubius Therapeutics, Inc., where she was responsible for overseeing and managing all of the company’s legal affairs. Before Rubius, she served as Associate General Counsel and Assistant Secretary at Progress Software Corporation, where she managed the company’s corporate, securities law, and M&A initiatives. Ms. Kamocsay began her career at Skadden, Arps, Slate, Meagher & Flom LLP, where she provided counsel to public and private company clients in the biotechnology and pharmaceutical industries on M&A, securities law, and corporate governance matters. Ms. Kamocsay holds a B.A. in History from the University of California, Los Angeles and a J.D. from Northeastern University School of Law.

About Carlsmed, Inc.

Carlsmed is a medical technology company pioneering AI-enabled personalized spine surgery solutions with a mission to improve outcomes and decrease the cost of healthcare for spine surgery and beyond.

Forward Looking Statement

Any statements in this press release about future expectations, plans and prospects, including statements about the Carlsmed’s ability to scale the impact of its aprevo technology platform and advance its personalized spine surgery platform to transform patient outcomes and drive long-term growth, Carlsmed’s current expectation of launching aprevo cervical in the United States in 2026, and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “likely,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including such important factors as are set forth under the caption “Risk Factors” in the Carlsmed’s Registration Statement on Form S-1 on file with the U.S. Securities and Exchange Commission. The forward-looking statements included in this press release represent Carlsmed’s views as of the date of this press release. Carlsmed anticipates that subsequent events and developments will cause its views to change. However, while Carlsmed may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Carlsmed’s views as of any date subsequent to the date of this press release.

Investor Relations
Caroline Corner, PhD
IR@Carlsmed.com

Media
LeAnn Burton
Senior Director Brand Marketing
LBurton@Carlsmed.com

Revolution Medicines Announces Key Leadership Additions, including Alan Sandler, M.D. as Chief Development Officer

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Revolution Medicines Announces Key Leadership Additions, including Alan Sandler, M.D. as Chief Development Officer




Revolution Medicines Announces Key Leadership Additions, including Alan Sandler, M.D. as Chief Development Officer

REDWOOD CITY, Calif., Sept. 29, 2025 (GLOBE NEWSWIRE) — Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, today announced the appointment of Alan Sandler, M.D. into the newly created role of chief development officer, as well as the appointment of regional general managers in the U.S. and Europe.

“I am delighted to welcome Alan as our chief development officer as we pursue our bold vision to develop new global standards of care for patients with RAS-addicted cancers,” said Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines. “As a physician-scientist, Alan is recognized as a leader in the field of lung cancer and has established a track record of excellence in oncology drug development. He brings valuable additional leadership to our organization as the scope and maturity of our development activities grow in support of advancing our compelling pipeline of distinguished clinical-stage RAS(ON) inhibitors on behalf of patients.”

Dr. Sandler joins Revolution Medicines from ALX Oncology, where he most recently served as chief medical officer. Prior to joining ALX Oncology, he was executive vice president and chief medical officer at Mirati Therapeutics through its acquisition by Bristol Myers Squibb. Previously, he served as president and head of global development, Oncology at Zai Lab Limited, and earlier held senior leadership roles at Genentech, a member of the Roche Group, where he drove multiple oncology development programs. Alan has also held academic leadership roles as division chief of Hematology/Oncology at Oregon Health and Science University, medical director of Thoracic Oncology at Vanderbilt University, and medical director of the Thoracic Oncology Program at Indiana University.

As a further step in building global commercial capabilities, Revolution Medicines has also appointed two key regional leaders: Alicia Gardner as senior vice president, general manager for the U.S. region, and Gerwin Winter as senior vice president, general manager for the European region. Alicia and Gerwin will play important leadership roles as the company prepares for the potential approvals and commercial launches of daraxonrasib in patients with cancers driven by RAS, including pancreatic ductal adenocarcinoma, as well as other innovative targeted medicines for patients living with RAS-addicted cancers.

About Revolution Medicines, Inc.
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; and zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor, are currently in clinical development. The company anticipates that RMC-5127, a RAS(ON) G12V-selective inhibitor, will be its next RAS(ON) inhibitor to enter clinical development. Additional development opportunities in the company’s pipeline focus on RAS(ON) mutant-selective inhibitors, including RMC-0708 (Q61H) and RMC-8839 (G13C). For more information, please visit www.revmed.com and follow us on LinkedIn.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this press release that are not historical facts may be considered “forward-looking statements,” including without limitation statements regarding the company’s development plans and timelines and its ability to advance its portfolio and R&D pipeline, its vision to develop new global standards of care and the potential approval and commercial launch of the company’s product candidates. Forward-looking statements are typically, but not always, identified by the use of words such as “may,” “will,” “would,” “believe,” “intend,” “plan,” “anticipate,” “estimate,” “expect,” and other similar terminology indicating future results. Such forward-looking statements are subject to substantial risks and uncertainties that could cause the company’s development programs, future results, performance or achievements to differ materially from those anticipated in the forward-looking statements. Such risks and uncertainties include without limitation risks and uncertainties inherent in the drug development process, including the company’s programs’ current stage of development, the process of designing and conducting preclinical and clinical trials, risks that the results of prior clinical trials may not be predictive of future clinical trials, clinical efficacy, or other future results, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, the company’s ability to successfully establish, protect and defend its intellectual property, other matters that could affect the sufficiency of the company’s capital resources to fund operations, reliance on third parties for manufacturing and development efforts, changes in the competitive landscape, and the effects on the company’s business of the global events, such as international conflicts or global pandemics. For a further description of the risks and uncertainties that could cause actual results to differ from those anticipated in these forward-looking statements, as well as risks relating to the business of Revolution Medicines in general, see Revolution Medicines’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the “SEC”) on August 6, 2025, and its future periodic reports to be filed with the SEC. Except as required by law, Revolution Medicines undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances, or to reflect the occurrence of unanticipated events.

Revolution Medicines Media & Investor Contact:
media@revmed.com
investors@revmed.com