Month: April 2024

JACKSONVILLE, Fla. – April 8, 2024 – MMI (Medical Microinstruments, Inc.), a robotics company dedicated to increasing treatment options and improving clinical outcomes for patients with complex conditions, today announced that its Symani Surgical System is now commercially available in the United States. The U.S. Food and Drug Administration (FDA) granted De Novo Classification to the robotic system for soft tissue manipulation to perform microsurgery, a highly specialized technique that involves reconnecting tiny vessels to restore blood flow or redirect fluid during reconstruction or repair.

The FDA authorization makes the Symani Surgical System the only commercially available platform in the U.S. for reconstructive microsurgery. The technology is positioned to open the field of microsurgery to new surgeons by quickly developing their skills, as well as to empower skilled microsurgeons to confidently expand into supermicrosurgery, creating a novel category of treatments that the human hand cannot perform without robotic assistance.

“The U.S. is facing a potentially dire shortage of physicians, and that shortage acutely impacts specialized fields of medicine, such as microsurgery,” said Mark Toland, CEO of MMI. “With the authorization from the FDA, our technology will expand its reach to pioneering hospitals in the U.S. It will help those hospitals grow their open surgical programs, expand the number of physicians who can perform these highly complicated procedures, and increase patient access to the most advanced techniques for surgeries in complex disease states, such as lymphedema. Our system will continue to provoke surgeons to challenge their definitions of ‘treatable’ and ‘untreatable’ and empower them to solve cases that have historically been too difficult to treat.”

Specific techniques used in microsurgery include reconnecting small anatomical structures, such as blood and lymphatic vessels, during open surgical procedures. Supermicrosurgery involves reconstruction or repair of even smaller vessels, typically less than 1mm in diameter, and fewer than 600 surgeons worldwide perform supermicrosurgery today.

The Symani Surgical System provides advanced solutions for a range of open surgeries, including post-mastectomy breast cancer reconstruction, extremity reconstruction using free tissue transfer, and lymphatic system repair.

“By making open surgery less invasive and more precise, we can treat more conditions and offer robotic-assisted surgical options to patients that simply do not exist today,” said Dr. L. Scott Levin, co-CMO of MMI. “Within the next five years, this expanded portfolio of addressable open surgical procedures is expected to exceed the number of eligible laparoscopic, or minimally invasive, procedures that leverage robotic assistance. The authorization from the FDA helps to solve a critical unmet need and will help surgeons perform a new category of complex open surgeries enabled by transformative technology.”

The Symani Surgical System offers surgeons entirely new capabilities because it features the world’s smallest surgical robotic wrist, called NanoWrist®. The unique design enables surgeons to replicate the natural movements of the human hand at the micro scale, which encourages a flatter learning curve in the training process. The articulated wrist features seven degrees of freedom that match the human wrist, tremor filtration and motion scaling, ultimately increasing precision and control.

Surgeons have leveraged the Symani Surgical System in nearly 1,000 clinical cases in the European Union and in thousands of preclinical cases around the world. The Symani Surgical System is available for commercial use in Europe and parts of Asia Pacific. MMI plans to immediately launch the technology in the U.S.

To learn more about MMI and the Symani Surgical System, visit MMI’s website here: https://mmimicro.com.

EINDHOVEN, the Netherlands — April 2, 2024 — ONWARD Medical N.V. (Euronext: ONWD), the medical technology company creating innovative spinal cord stimulation therapies to improve or restore movement, function, and independence in people with spinal cord injury (SCI), today announces it has submitted its De Novo application to the US Food and Drug Administration (FDA) to allow marketing of its breakthrough ARC-EX System to restore function of the upper extremities after SCI.

The submission marks an historic milestone for the Company in its mission to restore mobility and function for people with SCI. Once cleared by the FDA, ARC-EX will be the first-ever spinal cord stimulation therapy to restore hand and arm function after SCI and the first commercial product for ONWARD Medical. ONWARD prioritized upper limb function as its first indication for the ARC-EX System given feedback from the SCI Community of the importance of arm, hand, and finger function in empowering independence after SCI.

“We are delighted to be one step closer to bringing our breakthrough ARC-EX System to people living with SCI after submitting this De Novo application for regulatory clearance in the United States,” said ONWARD Medical CEO Dave Marver. “This therapy has the potential to transform the lives of people living with paralysis, while also positively impacting their loved ones.”

The De Novo application follows the Company’s global pivotal study – called Up-LIFT – the first large-scale pivotal study of transcutaneous spinal cord stimulation. The study investigated the safety and effectiveness of ARC-EX Therapy in improving upper limb strength and function in 65 study participants with chronic tetraplegia at 14 leading SCI neurorehabilitation centers in the United States, Canada, the United Kingdom, and the Netherlands. The study met all primary safety and effectiveness endpoints and demonstrated that 72% of participants responded to ARC-EX Therapy1, showing improvement both in strength and function.

“The SCI Community is eager to have access to this innovative technology,” said Candy Tefertiller, PT, DPT, PhD, NCS, Executive Director of Research and Evaluation, Craig Hospital in Lakewood, Colorado. “Even a small difference in hand and arm function can have a profound impact on independence and quality of life. The results of the Up-LIFT trial that led to this submission represent a significant advancement in the use of neuromodulation for individuals with spinal cord injury.”

The ONWARD ARC-EX System delivers ARC-EX Therapy™ – targeted, programmed electrical stimulation – transcutaneously to the spinal cord to increase strength, movement, and function of the upper limbs after SCI. The ARC-EX System was previously awarded FDA Breakthrough Device Designation (BDD) for upper limb function, which provided prioritized FDA review, the opportunity to interact with FDA experts, and the potential for additional reimbursement.

Nearly 200,000 people in the US and Europe have incomplete impaired upper extremity function after spinal cord injury.2,3 The Company is preparing for regulatory submission in Europe next.

To learn more about ONWARD Medical’s commitment to partnering with the SCI Community to develop innovative solutions for restoring movement, function, and independence after spinal cord injury, please visit ONWD.com.

*All ONWARD Medical devices and therapies, including but not limited to ARC-IM®, ARC-EX®, ARCBCI™, and ARC Therapy™, alone or in combination with a brain-computer interface (BCI), are investigational and not available for commercial use.

PHILADELPHIA, April 1, 2024 /PRNewswire/ — Carisma Therapeutics Inc. (NASDAQ: CARM) (“Carisma” or the “Company”), a clinical-stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, today reported financial results for the fourth quarter, and full year ended December 31, 2023, and provided a business update.

“Clinical data generated with CT-0508 in Study 101 has shown that CAR-M is well-tolerated, feasible to manufacture and biologically active in HER2 positive solid tumors. Combining this data set with the multiple potential advantages we’ve seen preclinically around a monocyte-based approach gives us confidence that CT-0525 may be a significant advancement in CAR-M treatment,” said Steven Kelly, President and Chief Executive Officer of Carisma. “We have therefore made the decision to focus our resources on the clinical development of the product we believe is best suited to deliver benefit to patients with significant unmet need.”

Mr. Kelly continued, “We have also undertaken a careful review of our business and prioritized our other pipeline programs on those with the greatest overall potential and near-term milestones. This prioritization enables us to reduce expenses and streamline operations, including a restructuring of our workforce. I want to express my sincere gratitude to those impacted by the workforce reduction for their invaluable contributions to our mission and their dedication to helping patients.”

Reprioritization Plan, Pipeline Updates, and Upcoming Milestones:

Ex Vivo Oncology

• Anti-human epidermal growth factor receptor 2 (Anti-HER2) Program
  • The Company’s goal to identify a registrational profile for the product candidate in its anti-HER2 program in 2025 remains unchanged.
  • In Study 101, CT-0508, a chimeric antigen receptor macrophage (CAR-Macrophage), was well-tolerated, remodeled the tumor microenvironment (TME), and induced anti-tumor T cell immunity in patients with HER2 3+ tumors that achieved stable disease, despite suboptimal dose and a patient population with exhausted T cells.
  • In late March 2024, Carisma made the decision to prioritize CT-0525, a chimeric antigen receptor monocyte (CAR-Monocyte), as the development candidate in its anti-HER2 program due to the potential for a CAR-Monocyte to have an approximately 2,000-fold increase in total exposure compared to a CAR-Macrophage. As a result, the Company believes that CT-0525 will be able to build on CT-0508’s observed clinical anti-tumor activity.
    
    
• CT-0525 (Anti-HER2 CAR-Monocyte)
  • In November 2023, Carisma announced the clearance of its Investigational New Drug application (IND) by the U.S. Food and Drug Administration (FDA) for CT-0525.
  • The Company expects to treat the first patient in the CT-0525 Phase 1 clinical study in the second quarter of 2024 and to report initial data from the study by year-end 2024.

• CT-0508 (Anti-HER2 CAR-Macrophage)
  • In September 2023, the Company reported preliminary data from 14 patients in the open label Phase 1 clinical study of CT-0508 (Study 101) designed to evaluate the safety, tolerability and manufacturing feasibility of CT-0508 along with several customary secondary endpoints.
  • The Company has also enrolled six patients in a Study 101 substudy evaluating the co-administration of CT-0508 and pembrolizumab, a programmed cell death protein 1 (PD-1) checkpoint inhibitor, evaluating the safety and tolerability of the co-administration, along with several customary secondary endpoints.
  • While the Company will continue all study operations for subjects enrolled in Study 101, it plans to stop recruitment of new patients into the study and its substudies, and expects to report data from the substudy evaluating the co-administration of CT-0508 and pembrolizumab in the second quarter of 2024.
    
    
• CT-1119 (Anti-Mesothelin CAR-Monocyte)
  • The Company has elected to pause further development of CT-1119 as part of its reprioritization plan, pending additional financing.

In Vivo Oncology

• Oncology (CAR-M + mRNA/LNP; Moderna Collaboration)
  • In November 2023, Carisma presented pre-clinical data from its in vivo program demonstrating that chimeric antigen receptor macrophages and monocytes (CAR-M) can be directly produced in vivo, successfully redirecting endogenous myeloid cells against tumor-associated antigens using mRNA/LNP. The data demonstrated feasibility, tolerability, and efficacy of in vivo CAR-M against metastatic solid tumors.
  • In December 2023, the Company announced the nomination of the first lead candidate in its collaboration with Moderna Tx, Inc., which will target an antigen present on a solid tumor with significant unmet medical need.

Fibrosis and Immunology

• Liver Fibrosis
  • Pre-clinical proof of concept data from the fibrosis program is targeted for the second quarter of 2024.

Corporate Updates

• As a result of the pipeline reprioritization and corporate restructuring, Carisma plans to reduce its workforce by approximately 37% in the second quarter of 2024.
  
  
• On April 1, 2024, Carisma announced the appointment of John Hohneker, M.D. to the Board of Directors of the Company, effective April 1, 2024. Dr. Hohneker brings over 30 years of extensive experience in drug development and leadership across the biotech and pharmaceutical sectors. The Company concurrently announced the resignation of Chidozie Ugwumba from Carisma’s Board of Directors, also effective April 1, 2024.

Fourth Quarter and Full Year 2023 Financial Results

• Cash and Cash Equivalents: As of December 31, 2023, Carisma had cash and cash equivalents of $77.6 million.
  
  
• R&D Expenses: Research and development (R&D) expenses were $19.4 million and $74.1 million for the fourth quarter and full year ended December 31, 2023, respectively, compared to $18.1 million and $56.6 million for the fourth quarter and full year ended December 31, 2022, respectively. The increase of $17.5 million year-over-year was primarily due to a $8.4 million increase in direct costs associated with pre-clinical development of CT-0525, a $4.4 million increase in personnel costs due to growth in research and development employee headcount, a $2.7 million increase in the Company’s facilities and other expenses resulting from increased laboratory space and laboratory supplies from expanded clinical and pre-clinical work, a $1.3 million increase due to costs associated with growth and expansion of pre-clinical activities towards submission of an IND for CT-0525, and a $0.9 million increase in direct costs associated with the pre-clinical development related to CT-1119, partially offset by a $0.2 million decrease in direct costs associated with CT-0508. The Company expects its research and development expenses to decrease in 2024 as it implements the revised operating plan, including a reduction in workforce, prioritization of CT-0525 and a pause in development of CT-1119. The Company expects that its expenses will increase again in future years as it continues to advance its clinical trials and potentially progress additional product candidates.
  
  
• G&A Expenses: General and administrative (G&A) expenses were $7.3 million and $29.5 million for the fourth quarter and full year ended December 31, 2023, respectively, compared to $1.0 million and $9.4 million for the fourth quarter and full year ended December 31, 2022, respectively. The increase of $20.1 million year-over-year was primarily attributable to a $9.2 million increase in personnel costs and a $7.5 million increase in professional fees. The increase in personnel costs was primarily due to non-recurring severance and other costs associated with the merger with Sesen Bio, Inc. on March 7, 2023 (“Merger”) of $4.6 million, and higher personnel costs as a result of an increase in headcount to support operating as a public company of $4.6 million. The increase in professional fees primarily consisted of $5.3 million in costs associated with activities to support the transitioning to and operating as a public company and protecting the Company’s IP portfolio, along with $2.2 million in legal fees and communication fees associated with the Merger. Insurance and taxes increased $2.1 million as a result of costs associated with operating as a public company, such as director and officer insurance. Facilities and supplies increased $0.8 million due to office expenditures resulting from an increased footprint, and other expenses increased $0.5 million. The Company expects that its general and administrative expenses will decrease in 2024 as its 2023 expenses included a significant amount of non-recurring costs related to the Merger and as it implements its revised operating plan, including reducing its workforce and decreasing expenses related to non-essential activities.
  
  
• Net Loss: Net loss was $86.9 million and $61.2 million for the years ended December 31, 2023, and 2022, respectively.

Outlook

Carisma anticipates that its cash and cash equivalents of $77.6 million as of December 31, 2023, combined with the expected cost savings from implementing the revised operating plan, are sufficient to sustain its planned operations into the third quarter of 2025.

About CT-0525

CT-0525 is a first-in-class, ex vivo gene-modified autologous chimeric antigen receptor-monocyte (CAR-Monocyte) cellular therapy intended to treat solid tumors that overexpress human epidermal growth factor receptor 2 (HER2). It is being studied in a multi-center, open label, Phase 1 clinical trial for patients with advanced/metastatic HER2-overexpressing solid tumors that have progressed on available therapies. The CAR-Monocyte approach has the potential to address some of the challenges of treating solid tumors with cell therapies, including tumor infiltration, immunosuppression within the tumor microenvironment, and antigen heterogeneity. CT-0525 has the potential to enable significant dose escalation, enhance tumor infiltration, increase persistence, and reduce manufacturing time compared to CT-0508.

About CT-0508

CT-0508 is an ex vivo gene-modified autologous chimeric antigen receptor-macrophage (CAR-Macrophage) cellular therapy intended to treat solid tumors that overexpress HER2. It is being evaluated in a Phase 1 multi-center clinical trial that focuses on patients with recurrent or metastatic HER2-overexpressing solid tumors whose cancers do not have approved HER2-targeted therapies or who do not respond to treatment. The Phase 1 clinical trial marks the first time that engineered macrophages are being studied in humans.

About Carisma

Carisma Therapeutics Inc. is a clinical stage biopharmaceutical company focused on utilizing our proprietary macrophage and monocyte cell engineering platform to develop transformative immunotherapies to treat cancer and other serious diseases. We have created a comprehensive, differentiated proprietary cell therapy platform focused on engineered macrophages and monocytes, cells that play a crucial role in both the innate and adaptive immune response. Carisma is headquartered in Philadelphia, PA. For more information, please visit www.carismatx.com.

Cautionary Note on Forward-Looking Statements

Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to Carisma’s business, strategy, future operations, cash runway, the advancement of Carisma’s product candidates and product pipeline, and clinical development of Carisma’s product candidates, including expectations regarding timing of initiation and results of clinical trials. The words “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “goals,” “intend,” “may,” “might,” “outlook,” “plan,” “project,” “potential,” “predict,” “target,” “possible,” “will,” “would,” “could,” “should,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

Any forward-looking statements are based on management’s current expectations of future events 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 include, but are not limited to, (i) Carisma’s ability to obtain, maintain and protect its intellectual property rights related to its product candidates; (ii) Carisma’s ability to advance the development of its product candidates under the timelines it anticipates in planned and future clinical trials and with its current financial and human resources; (iii) Carisma’s ability to replicate in later clinical trials positive results found in preclinical studies and early-stage clinical trials of its product candidates; (iv) Carisma’s ability to realize the anticipated benefits of its research and development programs, strategic partnerships, research and licensing programs and academic and other collaborations; (v) regulatory requirements or developments and Carisma’s ability to obtain and maintain necessary approvals from the U.S. Food and Drug Administration and other regulatory authorities related to its product candidates; (vi) changes to clinical trial designs and regulatory pathways; (vii) risks associated with Carisma’s ability to manage expenses; (viii) changes in capital resource requirements; (ix) risks related to the inability of Carisma to obtain sufficient additional capital to continue to advance its product candidates and its preclinical programs; and (x) legislative, regulatory, political and economic developments.

For a discussion of these risks and uncertainties, and other important factors, any of which could cause Carisma’s actual results to differ from those contained in the forward-looking statements, see the “Risk Factors” set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, as well as discussions of potential risks, uncertainties, and other important factors in Carisma’s other recent filings with the Securities and Exchange Commission. Any forward-looking statements that are made in this press release speak as of the date of this press release. Carisma undertakes no obligation to revise the forward-looking statements or to update them to reflect events or circumstances occurring after the date of this press release, whether as a result of new information, future developments or otherwise, except as required by the federal securities laws.

Investors:
Shveta Dighe
Head of Investor Relations

Media:
Julia Stern
(763) 350-5223

PHILADELPHIA, April 1, 2024 /PRNewswire/ — Carisma Therapeutics Inc. (Nasdaq: CARM) (“Carisma” or the “Company”), a clinical-stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, today announced the appointment of John Hohneker, M.D. to the Board of Directors of the Company, effective April 1, 2024. Additionally, the Company announced that Chidozie Ugwumba, who has served on Carisma’s Board of Directors since December 2020, has advised the Board of his intent to step down from his role as a member of the Board and chair of the Audit Committee of the Board effective April 1, 2024, as a result of his other professional commitments.

“We are pleased to welcome John to the Carisma Board of Directors,” said Sanford Zweifach, Chair of the Carisma Board of Directors. “I believe John’s extensive track record of clinical development, strategic leadership, and public company Board membership in the biopharmaceutical space will enable him to immediately support the Company as it continues leading the field of engineered macrophage development. We would also like to thank Chidozie for his invaluable advice and guidance since he first joined the Board over three years ago.”

“I am excited to join Carisma’s Board as the Company continues to develop innovative immunotherapies,” said Dr. Hohneker. “I am looking forward to partnering with the Board and the management team as they work to potentially bring novel treatments to patients in need across multiple therapeutic areas.”

Dr. Hohneker brings over 30 years of extensive experience in drug development and leadership across the biotech and pharmaceutical sectors. He most recently served as President and Chief Executive Officer of Anokion SA. Prior to this, he held the role of President of Research and Development at FORMA Therapeutics Inc. Before joining FORMA Therapeutics, Dr. Hohneker held roles of increasing responsibility at Novartis AG, including most recently as Senior Vice President and Global Head of Development, Immunology, and Dermatology. Prior to his time at Novartis, Dr. Hohneker held positions of increasing responsibility at Glaxo Wellcome and its legacy company, Burroughs Wellcome.

Dr. Hohneker currently serves on the Board of Directors of Curis, Inc., Sonata Therapeutics, Inc., and Trishula Therapeutics, Inc. Previously, Dr. Hohneker has served as a member of the Board of Directors of Torque Therapeutics, Inc., Dimension Therapeutics, Inc., Cygnal Therapeutics, Inc., BioTheryX Inc., Evelo Biosciences, Inc., Humanigen, Inc. and Aravive, Inc. Dr. Hohneker received his bachelor’s degree in chemistry from Gettysburg College and his M.D. from the Rutgers School of Biomedical and Health Sciences (formerly the University of Medicine and Dentistry of New Jersey-Rutgers Medical School). He completed his internship and residency in internal medicine and his fellowship in medical oncology, all at the University of North Carolina at Chapel Hill.