Inflammatory Breast Neoplasms

Initial results from the Phase 1 study of CT-0525, lead product candidate, expected in the first quarter of 2025 Nomination of a development candidate for liver fibrosis program expected in the first quarter of 2025 New preclinical efficacy data from the anti-GPC3 in vivo CAR-M therapy to be presented on November 8 at SITC 2024 Annual Meeting New preclinical efficacy data in liver fibrosis to be presented on November 17 at AASLD - The Liver Meeting ® 2024 Cash and cash equivalents of $26.9 million expected to fund the Company into the third quarter of 2025 PHILADELPHIA, Nov. 7, 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 quarter ended September 30, 2024, and highlighted recent business updates. "Our recent progress across clinical and preclinical programs demonstrates our commitment to pioneering therapies that address significant unmet medical needs," said Steven Kelly, President and CEO of Carisma Therapeutics. "We are advancing on multiple fronts. We expect to report initial data from the Phase 1 study of CT-0525 in the first quarter of 2025. We also recently nominated our first development candidate in hepatocellular carcinoma with Moderna and are excited to bring additional in vivo CAR-M therapies forward, including autoimmune targets. Our liver fibrosis program is progressing as well, with the nomination of a development candidate anticipated in the first quarter of 2025. These key milestones move us closer to delivering transformative treatments for patients in need." Third Quarter 2024 Highlights and Upcoming Milestones Ex Vivo Oncology CT-0525 (Anti-HER2 chimeric antigen receptor monocyte (CAR-Monocyte)) On November 5, 2024, Carisma announced the upcoming presentation of a trial in progress (TIP) poster for its Phase 1 clinical trial evaluating CT-0525, an autologous CAR-Monocyte therapy for the treatment of HER2+ solid tumors. The poster will be presented at the Society for Immunotherapy of Cancer (SITC) Annual Meeting in Houston, Texas, on November 8, 2024. In September 2024, Carisma submitted a protocol amendment for its Phase 1 study of CT-0525 to allow for the expansion of the study to include repeat dosing (up to two billion CAR positive cells administered every three weeks for up to five cycles) in combination with pembrolizumab, bolus dosing (up to10 billion CAR positive cells in a single dose) in combination with pembrolizumab, or either of these two dosing schedules as monotherapy (without checkpoint inhibitor). Repeat dosing in combination with pembrolizumab will be prioritized and the other three study arms may be activated as data indicates. Carisma expects to report initial data for Cohorts 1 and 2 of its Phase 1 study of CT-0525 in the first quarter of 2025. In Vivo Program (Moderna Collaboration) Autoimmune disease (CAR-M + mRNA/LNP) On September 10, 2024, Carisma announced the expansion of its in vivo chimeric antigen receptor macrophage and monocyte ("CAR-M") collaboration with Moderna, Inc. ("Moderna") to include the nomination of two research targets for the treatment of autoimmune diseases. Carisma retains all rights in autoimmune disease beyond the two nominated targets, which will be exclusively partnered with Moderna. GPC3+ solid tumors (CAR-M + mRNA/LNP) On November 5, 2024, Carisma announced the upcoming presentation of new pre-clinical data for its anti-GPC3 in vivo CAR-M therapy for the treatment of hepatocellular carcinoma (HCC), developed in collaboration with Moderna. These data will be presented in a poster session at the SITC Annual Meeting in Houston, Texas, on November 8, 2024. These preclinical data demonstrate robust anti-tumor activity and introduce a novel, off-the-shelf approach for GPC3+ solid tumors. Fibrosis On August 6, 2024, Carisma announced that new preclinical data for liver fibrosis will be highlighted in a poster presentation at the American Association for the Study of Liver Diseases (AASLD) - The Liver Meeting ® 2024, to be held November 15 through 19, 2024, in San Diego, California. Carisma expects to nominate a development candidate for its liver fibrosis program in the first quarter of 2025. Corporate Update On October 30, 2024, Carisma announced the appointment of Sohanya Cheng to the Board of Directors of the Company, effective October 31, 2024. Ms. Cheng brings over 20 years of experience in biopharmaceutical commercialization and research, with a strong focus on oncology. The Company concurrently announced the resignation of Michael Torok from Carisma's Board of Directors, also effective October 31, 2024. Third Quarter 2024 Financial Results Cash and cash equivalents as of September 30, 2024, were $26.9 million, compared to $40.4 million as of June 30, 2024. Research and development expenses for the three months ended September 30, 2024 were $11.3 million, compared to $19.6 million for the three months ended September 30, 2023. The decrease of $8.3 million was primarily due to implementation of our revised operating plan in the second quarter of 2024 in which we halted further development of CT-0508, paused development of CT-1119 and implemented a workforce reduction. As result of the revised operating plan, we experienced a decrease of $2.4 million related to halting development of CT-0508 and a $0.1 million decrease from pausing the development of CT-1119. In addition, the implementation of the revised operating plan resulted in a decrease in facilities and other expenses of $3.1 million due to less laboratory supplies and laboratory space needs and a $0.9 million decrease in direct personnel costs due to a reduction in headcount. Further, we experienced a $0.9 million decrease in direct costs associated with pre-clinical development of CT-0525 due to the timing of the development program and a decrease of $0.9 million in other clinical and pre-clinical development expenses resulting from the timing of certain studies in our in vivo collaboration with Moderna. General and administrative expenses for the three months ended September 30, 2024 were $5.2 million, compared to $6.6 million for the three months ended September 30, 2023. The decrease of $1.4 million was primarily due to our revised operating plan in which we recognized a $1.3 million decrease in professional fees as a result of our patent portfolio and expanding infrastructure in 2023, a $0.3 million decrease in facilities and supplies due to a decrease in office expenditures, a $0.2 million decrease in insurance costs, and a $0.1 million decrease in other expenses related to a decline in travel costs, partially offset by a $0.5 million increase in personnel costs driven by an increase in stock-based compensation. Net loss was $12.7 million for the third quarter of 2024, compared to a $21.4 million net loss for the same period in 2023. Outlook Carisma anticipates that its cash and cash equivalents of $26.9 million as of September 30, 2024 are sufficient to sustain its planned operations into the third quarter of 2025. The Company's cash forecast contains estimates and assumptions, and management cannot predict the timing of all cash receipts and expenditures with certainty. Variances from management's estimates and assumptions could impact the Company's liquidity prior to 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 macrophage therapy. About Carisma Therapeutics 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 . 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 realize the anticipated benefits of its pipeline reprioritization and corporate restructuring, (ii) Carisma's ability to obtain, maintain and protect its intellectual property rights related to its product candidates; (iii) 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; (iv) Carisma's ability to replicate in later clinical trials positive results found in preclinical studies and early-stage clinical trials of its product candidates; (v) 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; (vi) 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; (vii) changes to clinical trial designs and regulatory pathways; (viii) risks associated with Carisma's ability to manage expenses; (ix) changes in capital resource requirements; (x) risks related to the inability of Carisma to obtain sufficient additional capital to continue to advance its product candidates and its preclinical programs; and (xi) 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, its Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, 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 [email protected] Media Contact: Julia Stern (763) 350-5223 [email protected] SOURCE Carisma Therapeutics Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

SALT LAKE CITY, Oct. 08, 2024 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. , (NASDAQ: MYGN), a leader in genetic testing and precision medicine, today announced a series of ongoing research collaborations to study the use of molecular residual disease (MRD) testing in breast cancer using Myriad’s Precise ® MRD test. Research collaborations include: A study to determine whether circulating tumor DNA (ctDNA) level may predict magnitude of response to pembrolizumab and hormonal therapy in patients with HR-positive inflammatory breast cancer who did not achieve pathological complete response at the time of surgery, led by Bora Lim, MD, at The University of Texas MD Anderson Cancer Center. A study to evaluate whether ctDNA levels correlate with nodal involvement in patients with newly diagnosed HR-positive breast cancer and, if so, how the correspondence may be used to aid in surgical decision making, led by Anna Weiss, MD, at The University of Rochester Medical Center. The multicenter, prospective MONITOR-breast study to determine the association of ctDNA levels to both neoadjuvant and adjuvant therapy in patients with newly diagnosed breast cancer across all subtypes. The study will involve 650 patients and will assess the prognostic potential of ctDNA and the lead time of detecting recurrence earlier ahead of standard-of-care imaging. The multicenter, prospective study JBCRG-C11 (CREA) to evaluate the maintenance of complete response with trastuzumab deruxtecan (T-DXd) in HER2-positive advanced or metastatic breast cancer patients and whether ctDNA can be used to optimally guide therapy, led by Yoichi Naito, MD, of the National Cancer Center Hospital East in Japan. A study in partnership with Aptitude Health to assess ctDNA levels in high-risk patients at diagnosis, during neoadjuvant treatment, and following surgery in community oncology settings. “Relative to many other cancer types that typically have high levels of ctDNA in the blood, breast cancer often has very low levels of ctDNA, which makes MRD testing a challenge,” said Dale Muzzey, chief scientific officer, Myriad Genetics. “Myriad’s Precise MRD test is well suited to overcome this challenge because it tracks up to 1,000 tumor-specific variants identified via whole-genome sequencing. The research efforts we’re undertaking with leading organizations and investigators are an important step in advancing the clinical application of next-generation MRD testing to the treatment and monitoring of breast cancer.” Myriad continues to develop its Precise MRD test to meet the needs of cancer patients, academic partners, and biopharma companies. Myriad has previously announced other MRD collaborations, including a metastatic breast cancer study with researchers at Memorial Sloan Kettering Cancer Center and a prospective pan-cancer study, including breast cancer, led by researchers at the National Cancer Center Hospital East in Japan. About Myriad’s Precise MRD Test Myriad’s Precise MRD test is a tumor-informed, whole genome sequencing (WGS) based test that monitors hundreds to thousands of tumor-specific variants, which enables exceptional sensitivity and quantification of circulating tumor DNA (ctDNA) in the blood of patients with cancer. The Precise MRD test can be used to monitor ctDNA levels throughout a cancer patient’s clinical care, starting immediately after diagnosis and continuing through treatment and surveillance. The Precise MRD test is available for use in research studies pursued jointly by Myriad and academic or pharmaceutical investigators. About Myriad Genetics Myriad Genetics is a leading genetic testing and precision medicine company dedicated to advancing health and well-being for all. Myriad develops and offers genetic tests that help assess the risk of developing disease or disease progression and guide treatment decisions across medical specialties where genetic insights can significantly improve patient care and lower healthcare costs. For more information, visit . Myriad Safe Harbor Statement This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including that the company’s research collaborations, such as a study that will involve 650 patients and will assess the prognostic potential of ctDNA and the lead time of detecting recurrence ahead of standard-of-care imaging, represent an important step in advancing the clinical application of next-generation MRD testing to the treatment and monitoring of breast cancer and that the company’s Precise MRD test is well suited to overcome some of the challenges faced by MRD testing because it tracks up to 1,000 tumor-specific variants identified via whole-genome sequencing. These “forward-looking statements” are management’s expectations of future events as of the date hereof and are subject to known and unknown risks and uncertainties that could cause actual results, conditions, and events to differ materially and adversely from those anticipated. Such factors include those risks described in the company’s filings with the U.S. Securities and Exchange Commission, including the company’s Annual Report on Form 10-K filed on February 28, 2024, as well as any updates to those risk factors filed from time to time in the company’s Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. Myriad is not under any obligation, and it expressly disclaims any obligation, to update or alter any forward-looking statements, whether as a result of new information, future events or otherwise except as required by law. Investor Contact Matt Scalo (801) 584-3532 IR@myriad.com Media Contact Glenn Farrell (385) 318-3718 PR@myriad.com

KING OF PRUSSIA, Pa., Aug. 12, 2024 /PRNewswire/ -- The Association for Frontotemporal Degeneration (AFTD) announced Monday that the Milburn Foundation, a private charitable organization, provided a $25,000 challenge match for their "Empowered Together to #EndFTD" campaign. The campaign more than doubled its goal, securing the match and raising $75,000 to support AFTD's mission to improve the quality of life of people affected by frontotemporal dementia (FTD) and driving research to a cure. "We are deeply grateful to the Milburn Foundation for their support of AFTD's mission and this campaign," said AFTD CEO Susan Dickinson. "These funds will directly support families and individuals facing a diagnosis, and will help educate healthcare professionals and policymakers so that we can develop earlier and more accurate diagnosis and better care services." The Milburn Foundation is a private foundation that structures strategic partnerships with public charities to drive philanthropic innovation for both Frontotemporal Degeneration and Inflammatory Breast Cancer. "Families facing FTD, much like families facing breast cancer, urgently need access to viable treatments and a cure," said Milburn Foundation CEO Bryon Davis. "Our gift to AFTD embodies our commitment to true partnership and collaboration in the field of disease research. The Milburn Foundation shares AFTD's mission to hasten a future without FTD, and we hope these funds can contribute to the FTD-free world sought by both our organizations." AFTD works every day to empower the FTD community by supporting persons diagnosed, care partners, and families at every stage of the FTD journey, and taking action to educate others, advance research, and raise vital awareness. The campaign featured six personal stories from the FTD community, including caregivers and family members, across print and digital channels. Channing Clifford, who has a popular TikTok channel where she connects with families on the FTD journey, was featured in the campaign. "Any time I have knowledge of what to do next, it's because of AFTD. It's empowering to know that this organization not only offers support for the tough parts of this diagnosis, but also communicates with people affected," she said. FTD is a neurodegenerative disorder that causes the gradual breakdown of nerve cells in the frontal and temporal lobes of the brain. The progression of the disease can lead to significant disability over time, including extreme changes in personality, behavior, language, and motor skills that can impact daily functioning and require around-the-clock care and support. FTD typically strikes individuals between the ages of 40 and 65, but it can also occur in both older and younger individuals. On average, it takes nearly four years for a person to receive an accurate FTD diagnosis as symptoms are often misdiagnosed as a psychiatric condition, Alzheimer's disease, or Parkinson's disease. This delay is often due to the medical community's lack of familiarity with FTD. Delays in diagnosis can also cause devastating financial hardships for families, with the economic burden of FTD being almost twice that of Alzheimer's disease, as individuals impacted are often compelled to leave the workforce during peak earning years. To learn more about AFTD and its work, go to . About AFTD AFTD is the leading organization focused on helping people and families impacted by FTD, and driving research for a cure. Our organization is committed to facilitating and funding FTD-focused research that can hold the key to ensuring more accurate diagnosis, prevention, treatments, and a cure, with implications for other forms of dementia and related neurodegenerative diseases. About the Milburn Foundation The Milburn Foundation, an award-winning philanthropic partner to public charities, funds critical disease research and creates grant agreements to unite organizations with shared causes. Since 2007, we've catalyzed collaboration among research institutions, public charities, and patient advocates to explore, publish, and validate solutions to persistent research challenges. Additionally, we've helped raise millions of dollars through innovative fundraising approaches, such as challenge-matching grants. Contacts: Cristian Salazar The Lead PR 929-584-8731 or [email protected] SOURCE The Association For Frontotemporal Degeneration