Entry into a Material Definitive Agreement

On November 22, 2023, Adhera Therapeutics, Inc., a Delaware corporation ("Adhera" or the "Company") reported to have entered into an Assignment and Exchange Agreement (the "Agreement") with Biodexa Pharmaceuticals PLC, a public limited company organized under the laws of England and Wales ("Biodexa"), and certain holders (the "Secured Noteholders") of outstanding secured notes issued by Adhera (the "Secured Notes") having a combined total amount of $7,832,927, pursuant to which Adhera agreed to assign all of its rights to the compound tolimidone under its license agreement dated August 20, 2021, as amended, with Melior Pharmaceuticals I, Inc., a Delaware corporation ("Melior") to Biodexa in exchange for Biodexa agreeing to issue consideration to Adhera and the Secured Noteholders (as more specifically described below), and the Secured Noteholders in turn agreeing to the elimination and release of Adhera from the Secured Notes and the Secured Noteholders’ rights and interests and Adhera’s obligations incident thereto, subject in each case to the terms and conditions set forth in the Agreement (Filing, 8-K, Adhera Therapeutics, NOV 22, 2023, View Source [SID1234638035]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

In connection with the assignment, Biodexa agreed to pay $300,000 in cash to Adhera (the "Initial Cash Consideration") and issue $2,000,000 of its American Depositary Shares ("Depositary Shares"), each Depositary Share representing 400 of Biodexa’s ordinary shares, nominal value £0.001 per share (the "Ordinary Shares"), valued at the final offering price per Class A Unit ("Class A Offering Price") to be offered by Biodexa in a registered offering (the "Biodexa Offering"), to the Secured Noteholders. In addition, provided the Secured Noteholders, as a group, subscribe for not less than $4,000,000 of Class A Units in the Biodexa Offering, Biodexa agreed to pay a further $400,000 in cash to Adhera and issue a further $3,000,000 of its Depositary Shares, valued at the Class A Offering Price, to the Secured Noteholders. There is no guarantee the Secured Noteholders will purchase a sufficient amount of units in the Biodexa Offering to entitle Adhera to the additional payment contemplated by the Agreement. The Agreement also provides for additional payments, totaling $4,000,000 of Depositary Shares in the aggregate, to be issued to the Secured Noteholders upon the completion of a positive Phase II clinical study of tolimidone in Type-1 diabetes and upon the first commercial sale of tolimidone.

Upon receipt of the Depositary Shares issued pursuant to the Agreement as of the closing of the transactions contemplated thereby (the "Closing"), the Secured Noteholders have agreed to cancel and terminate, in full, their respective Secured Notes and any related security agreements and interests. The Closing is subject to customary closing conditions, including, among other things, the closing of the Biodexa Offering.

Further, in connection with the execution of the Agreement, Biodexa entered into a side letter agreement with Adhera under which Biodexa advanced to Adhera $60,000 of the Initial Cash Consideration, which will be credited against the Initial Cash Consideration payable at the Closing or, if the Closing does not occur by March 31, 2024, repaid in full by Adhera.

The foregoing description of the Agreement and the transactions contemplated thereby does not purport to be complete, and is qualified in its entirety by reference to the full text of the Agreement and side letter agreement, copies of which are filed hereto as Exhibits 10.1 and 10.2, respectively, and are incorporated by reference herein.

Incendia Therapeutics to Present at 35th Annual Piper Sandler Healthcare Conference

On November 22, 2023 Incendia Therapeutics, a precision oncology company discovering and developing a novel class of therapies that reprogram the tumor microenvironment (TME), reported that Chief Executive Officer, Wendye R. Robbins, M.D., will present a corporate overview at the 35th Annual Piper Sandler Healthcare Conference on Thursday, November 30, 2023 at 2:50 pm ET (Press release, Incendia Therapeutics, NOV 22, 2023, View Source [SID1234637949]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!


Bayer Championing Advancements in Radiology Pipeline and Accelerating AI Innovation

On November 22, 2023 Bayer reported to advance its comprehensive Radiology portfolio with progress in the development pipeline for an investigational contrast agent as well as new innovations in the area of Artificial Intelligence (AI) (Press release, Bayer, NOV 22, 2023, View Source [SID1234637948]). The company announced that new clinical data for gadoquatrane, Bayer’s investigative macrocyclic gadolinium-based compound currently in Phase III development, will be presented at the 2023 Radiological Society of North America (RSNA) Annual Meeting – taking place from November 26 to 30 in Chicago, USA. In addition, Bayer announced four collaboration agreements, adding additional applications to its digital platform Calantic Digital Solutions and will announce the publication of a Bayer funded health economic modeling analysis that evaluated cost effectiveness of supplemental imaging for screening breast cancer in women with dense breasts.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The activities at RSNA reflect Bayer’s commitment as a leading company in key areas of radiology to accelerate innovation and address today’s industry challenges for the benefit of patients and their clinicians.

New clinical data for investigational contrast agent gadoquatrane being presented at RSNA 2023:

International Multicenter Phase 2 Dose Finding Study of Gadoquatrane: A Dose of 0.04 mmol Gd/ kg body weight (bw) of Gadoquatrane compared to 0.1 mmol Gd/kg bw of Gadobutrol

Background: Gadoquatrane, Bayer’s investigative macrocyclic gadolinium-based compound is currently in Phase III of development.
The Purpose of this Phase II study was to establish a dose of gadoquatrane in comparison to gadobutrol.
The Phase II results supported the further development of gadoquatrane in a broad Phase III program.
Session Number W7-SSNR13
Fostering innovation in Radiology AI

In more than 30 sessions, Bayer’s AI team composed jointly of experts from both Calantic Digital Solutions and Blackford Analysis, will share their insights to help customers advance their AI strategy – by offering various tech talks, including "Spark Tank Sessions" where early-stage app companies can learn new ways to refine their value proposition and market their AI. Bayer will also host thought leadership panel discussions with topics like regulatory challenges in the field of AI in medical imaging, app selection and leverage clinical utility frameworks to assess ROI.

Building on technology from Blackford and adding additional workflow and analytics components, Bayer’s own platform Calantic Digital Solutions delivers access to applications for medical imaging, including those enabled by AI. Calantic SPARK, Bayer’s accelerator program for medical imaging app developers to further foster innovation in radiology AI, will showcase Imagine Software and Scanslated. Bayer’s Calantic Spark is a targeted program to help radiology AI startups of all stages get to market faster by offering advice spanning medical, regulatory, reimbursement expertise, and market access. Acting as a fast-track pathway to commercialization and distribution through Calantic Digital Solutions.

New Insights into Cost Effectiveness of Supplemental Screening Modalities for Dense Breasts

During RSNA Bayer will announce the publication of a novel health economic model in the Journal of Medical Economics, funded by Bayer, analyzing cost effectiveness of supplemental imaging modalities for women with dense breasts at average and intermediate risk of breast cancer.

Bayer is also hosting an immersive tour of a radiology clinic of the future through the eyes of a patient.

Boehringer Ingelheim expands immuno-oncology portfolio with the acquisition of bacterial cancer therapy specialist T3 Pharma

On November 22, 2023 Boehringer Ingelheim reported the acquisition of privately-held T3 Pharmaceuticals AG ("T3 Pharma"), a clinical stage Swiss biotech company, for an amount of up to 450 million CHF (Press release, Boehringer Ingelheim, NOV 22, 2023, View Source [SID1234637947]). T3 Pharma has developed a proprietary therapy platform that uses live bacteria to deliver immune-modulating proteins to cancer cells and tumor micro-environments.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Despite the significant transformation of the cancer treatment landscape by immunotherapies, long-term remissions only occur in 15-20% of cancer patients. Boehringer Ingelheim aims to considerably increase this rate by utilizing complementary immuno-oncology platforms such as T-Cell Engagers (TcEs), oncolytic viruses, and cancer vaccines, which have the potential to turn cold tumors into hot ones, extending the benefits of immunotherapy to more patients in need.

T3 Pharma’s pioneering technology will bolster Boehringer Ingelheim’s array of novel immune-modulatory cancer treatments, reinforcing the company’s oncology strategy to transform the lives of people affected by cancer.

"The acquisition of T3 Pharma will significantly expand our immuno-oncology pipeline portfolio and is synergistic with many of our existing R&D programs. This will bring us closer to achieving our vision of driving a paradigm shift in cancer care treatments," said Michel Pairet, Member of the Board of Managing Directors at Boehringer Ingelheim with responsibility for the Innovation Unit.

"We are extremely proud of the work of T3 Pharma’s team and very excited to continue and accelerate the successful development of our bacterial delivery platform as part of Boehringer Ingelheim. Being integrated with our partners at Boehringer will enable us to realize the full potential of our platform to fight solid cancers," said Simon Ittig, CEO of T3 Pharma.

T3 Pharma has developed a unique platform using engineered Yersinia enterocolitica bacteria to deliver bioactive proteins directly and selectively into the tumor micro-environment, while sparing healthy tissues. The bacteria can be loaded with multiple immune-modulatory proteins of choice, enabling the design of immuno-oncology combination therapies in one single agent.

Boehringer Ingelheim is adopting a comprehensive approach to cancer therapy development including both cancer cell-directed and immuno-oncology approaches. This strategy aims to enable smart combinations that deliver life-changing and best-in-class treatments that may offer the greatest benefit for people affected by cancer. To make this ambition a reality, the company is constantly exploring emerging science cooperating with a growing global network of leading academic and industry partners and by investing in startup companies via its Boehringer Ingelheim Venture Fund, which was among the main investors of T3 Pharma.

T3 Pharma is headquartered in Allschwil near Basel, Switzerland, where it was founded with financial backing from both corporate and institutional investors. Operations of T3 Pharma will be kept in the Basel region following the acquisition.

Carisma Therapeutics to Participate in Evercore ISI HealthCONx Conference

On November 22, 2023 Carisma Therapeutics Inc. (Nasdaq: CARM) ("Carisma" or the "Company"), a clinical-stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, reported that Steven Kelly, President and Chief Executive Officer, will participate in a fireside chat at the 6th Annual Evercore ISI HealthCONx Conference on Wednesday, November 29 at 2:35 pm ET (Press release, Carisma Therapeutics, NOV 22, 2023, https://www.prnewswire.com/news-releases/carisma-therapeutics-to-participate-in-evercore-isi-healthconx-conference-301995316.html [SID1234637946]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

An audio webcast of the event will be available on the Company’s Investor Events section of the Investor Relations webpage and will be archived for a limited time following the event.