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BASKING RIDGE, N.J., April 15, 2025 (GLOBE NEWSWIRE) — Lisata Therapeutics, Inc. (Nasdaq: LSTA) (“Lisata” or the “Company”), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases, today announced that the Company has entered into a research license with Catalent, Inc. (“Catalent”) to evaluate, in a preclinical setting, the efficacy of Lisata’s iRGD cyclic peptide product candidate, certepetide, as a payload used in the context of Catalent’s SMARTag^® antibody-drug conjugate (“ADC”) dual-payload technology platform for the treatment of difficult-to-treat-diseases, including advanced solid tumors.   Under the terms of the agreement, Catalent will assume full responsibility for all research and development expenses and Lisata will provide consulting support. Further, Lisata will receive an upfront payment with the possibility of future considerations contingent upon the results of the preclinical evaluation.

“This is another obvious step in the development of Lisata and certepetide as we see great potential in combining both the technologies and the talents of the scientific teams at Lisata and Catalent to study the combination of certepetide and the SMARTag^® ADC platform. While ADCs utilize monoclonal antibodies to target tumor-specific antigens ensuring precise delivery of cytotoxic drugs to cancer cells while sparing healthy tissues, combining ADC’s with certepetide should ensure that the targeted payload penetrates the tumor. The combination of ADCs and certepetide could revolutionize precision oncology delivering targeted therapies deep within tumors for improved efficacy with reduced systemic toxicity. Additionally, the presence of certepetide in the tumor microenvironment (TME) is expected to reduce the immunosuppressive nature of the TME further improving patient response and outcomes to the ADC therapy.” stated Kristen K. Buck, M.D., Executive Vice President of Research and Development and Chief Medical Officer of Lisata. “This agreement furthers our strategy of exploiting certepetide’s broad applicability and unlocking its full potential. We look forward to seeing results in the near future.”

“We are excited to partner with Lisata to investigate how certepetide and the SMARTag^® technology might be used together to make ADCs with enhanced functions,” stated Penelope Drake, Head of R&D, Bioconjugates at Catalent. “We are enthusiastic about the potential of this collaboration to deliver innovative treatment options.”

About Lisata Therapeutics

Lisata Therapeutics is a clinical-stage pharmaceutical company dedicated to the discovery, development and commercialization of innovative therapies for the treatment of advanced solid tumors and other major diseases. Lisata’s cyclic peptide product candidate, certepetide, is an investigational drug designed to activate a novel uptake pathway that allows co-administered or tethered anti-cancer drugs to selectively target and penetrate solid tumors more effectively. Lisata has already established noteworthy commercial and R&D partnerships based on its CendR Platform^® technology. The Company expects to announce numerous milestones over the next 1.5 years and believes that its projected capital will fund operations into the second quarter of 2026, encompassing anticipated data milestones from its ongoing and planned clinical trials. Learn more about certepetide’s mechanism of action in our short film. For more information on the Company, please visit www.lisata.com.

About Certepetide

Certepetide (formerly LSTA1), an internalizing RGD (arginylglycylaspartic acid or iRGD), cyclic peptide product candidate, is an investigational drug designed to activate a novel uptake pathway that allows co-administered or tethered anti-cancer drugs to target and penetrate solid tumors more effectively. Certepetide actuates this active transport system in a tumor-specific manner, resulting in systemically co-administered anti-cancer drugs more efficiently penetrating and accumulating in the tumor. Certepetide also has been shown to modify the tumor microenvironment resulting in tumors which are more susceptible to immunotherapies. We and our collaborators have amassed significant non-clinical data demonstrating enhanced delivery of a range of emerging anti-cancer therapies, including immunotherapies and RNA-based therapeutics. To date, certepetide has also demonstrated favorable safety, tolerability, and clinical activity in completed and ongoing clinical trials designed to test its ability to enhance the effectiveness of standard-of-care chemotherapy for pancreatic cancer. Lisata is exploring the potential of certepetide to enable a variety of treatment modalities to treat a range of solid tumors more effectively. Certepetide has been awarded Fast Track designation (U.S.) and Orphan Drug Designation for pancreatic cancer (U.S. and E.U.) as well as Orphan Drug Designation for glioma (U.S.) and osteosarcoma (U.S.). Additionally, certepetide has received Rare Pediatric Disease Designation for osteosarcoma (U.S.).

Forward-Looking Statements

This communication contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this communication regarding the Company’s clinical development programs are forward-looking statements. In addition, when or if used in this communication, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to Lisata or its management, may identify forward-looking statements. Examples of forward-looking statements include, but are not limited to, the potential of the collaboration with Catalent to develop treatment options; the potential efficacy of certepetide as a treatment for patients with solid tumors; our beliefs about the potential uses and benefits of certepetide; statements relating to Lisata’s continued listing on the Nasdaq Capital Market; expectations regarding the capitalization, resources and ownership structure of Lisata; the approach Lisata is taking to discover and develop novel therapeutics; the adequacy of Lisata’s capital to support its future operations and its ability to successfully initiate and complete clinical trials; and the difficulty in predicting the time and cost of development of Lisata’s product candidates. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: results observed from a single patient case study are not necessarily indicative of final results and one or more of the clinical outcomes may materially change following more comprehensive reviews of the data and as more patient data becomes available, including the risk that unconfirmed responses may not ultimately result in confirmed responses to treatment after follow-up evaluations; the risk that product candidates that appeared promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later clinical trials; the safety and efficacy of Lisata’s product candidates, decisions of regulatory authorities and the timing thereof, the duration and impact of regulatory delays in Lisata’s clinical programs, Lisata’s ability to finance its operations, the likelihood and timing of the receipt of future milestone and licensing fees, the future success of Lisata’s scientific studies, Lisata’s ability to successfully develop and commercialize drug candidates, the timing for starting and completing clinical trials, rapid technological change in Lisata’s markets, the ability of Lisata to protect its intellectual property rights; and legislative, regulatory, political and economic developments. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in Lisata’s Annual Report on Form 10-K filed with the SEC on February 27, 2025, and in other documents filed by Lisata with the Securities and Exchange Commission. Except as required by applicable law, Lisata undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events, or otherwise.

Lisata Therapeutics Contact:

Investors:
Lisata Therapeutics
John Menditto
Vice President, Investor Relations and Corporate Communications
Phone: 908-842-0084
Email: [email protected]

Media:
ICR Healthcare
Elizabeth Coleman
Account Supervisor
Phone: 203-682-4783
Email: [email protected]

This press release was published by a CLEAR® Verified individual.

WEST PALM BEACH, Fla., April 15, 2025 (GLOBE NEWSWIRE) — Sunrise Realty Trust, Inc. (“SUNS” or “the Company”) (NASDAQ: SUNS), a lender on the Tannenbaum Capital Group (“TCG”) Real Estate platform, today announced that it will release its financial results for the first quarter ended March 31, 2025 on Wednesday, May 7^th, 2025 before market open. Management will review SUNS’ financial results at 10:00 am ET via webcast available on the Investor Relations website at ir.sunriserealtytrust.com, or by registering in advance at this link. To participate in the live conference call, dial 888-672-2415 (or 646-307-1952 for international callers) and provide Conference ID 6235201. A replay will be available one hour after the event.

SUNS distributes its earnings releases via its website and email lists. Those interested in receiving firm updates by email can sign up for them here.

About Sunrise Realty Trust, Inc.
Sunrise Realty Trust, Inc. (NASDAQ: SUNS) is an institutional commercial real estate (“CRE”) lender providing flexible financing solutions to sponsors of CRE projects in the Southern United States. It focuses on transitional CRE business plans with the potential for near-term value creation, collateralized by top-tier assets in established and rapidly expanding Southern markets. For additional information regarding the Company, please visit www.sunriserealtytrust.com.

About TCG Real Estate
TCG Real Estate refers to a group of affiliated CRE-focused debt funds, including a Nasdaq-listed mortgage REIT, Sunrise Realty Trust, Inc. (NASDAQ: SUNS), and a private mortgage REIT, Southern Realty Trust, Inc. The funds provide flexible financing on transitional CRE properties that present opportunities for near-term value creation, with a focus on top-tier CRE assets located primarily within markets in the Southern U.S. benefitting from economic tailwinds with growth potential.

Investor Relations Contact

Robyn Tannenbaum
561-510-2293
[email protected]

Media Contact

Profile Advisors
Rich Myers & Rachel Goun
347-774-1125
[email protected]

WARRINGTON, Pa., April 15, 2025 (GLOBE NEWSWIRE) — Windtree Therapeutics, Inc. (“Windtree” or “the Company”) (NasdaqCM: WINT), a biotechnology company focused on advancing early and late-stage innovative therapies for critical conditions, today reported financial results for the fiscal year ended December 31, 2024 and provided key business updates.

“The year 2024 saw Windtree make great progress in many key areas including clinical development of our lead drug candidate istaroxime in cardiogenic shock, business development and the future strategy of the Company,” said Jed Latkin, CEO of Windtree. “Cardiogenic shock is a critical condition with high morbidity and mortality where clinicians express a high need for drug innovation. During the year, we announced positive results of our SEISMiC Extension Phase 2 istaroxime clinical study in early cardiogenic shock (SCAI Stage B) and also began our cardiogenic shock SEISMiC C (SCAI Stage C) Phase 2 study with an interim assessment planned for Q3 2025. In addition, we added a regional licensing partnership with Lee’s Pharmaceutical for greater China.for istaroxime, our preclinical dual mechanism SERCA2a activators and rostafuroxin. We are also continuing discussions with potential partners for our cardiovascular drug candidates.” Mr. Latkin further added, “Importantly, we also announced our new corporate strategy in early 2025 to become a revenue-generating biotech by using Company equity to acquire small biotech companies struggling to maximize the commercial potential of their FDA-approved products. We believe this could be a positive transformation and an opportunity to provide near-term value to our shareholders. As part of our strategy, we are actively evaluating revenue-generating opportunities across various sectors that align with our capabilities and strategic vision.”

Mr. Latkin was appointed CEO in December of 2024. He has nearly three decades of financial and biotech experience including prior experience as the CEO of a public biotech company. Mr. Latkin served as the CEO of Navidea Biopharmaceuticals where he started as Chief Financial Officer and executed multiple deals and raised substantial funding. He has also served as CEO of Black Elk Energy Offshore in 2014 as part of Nagel Avenue Capital which he joined after ten years on Wall Street with a variety of investment banking organizations and funds, including ING, Morgan Stanley and Citigroup Securities. Most recently, Mr. Latkin served as the Chief Operating Officer and head of finance at ProPhase Labs, conducting deals and managing broad aspects of the business.

Key Business Update

• Announced positive results from its Phase 2 SEISMiC Extension Study of istaroxime in the treatment of early cardiogenic shock in September 2024.
• Initiated enrollment in the global SEISMiC C trial evaluating istaroxime in SCAI Stage C cardiogenic shock—a more severely ill population than previously studied—building on positive SEISMiC A and B results; the placebo-controlled, double-blind study will assess istaroxime’s impact on systolic blood pressure and cardiac function alongside standard inotropic/vasopressor therapy, with a planned interim data review in Q3 2025 to inform Phase 3 readiness and regulatory discussions in early 2026.
• Launched a new corporate strategy to become a revenue generating biotech company through acquisitions of small companies and their FDA-approved products while continuing to progress the Company’s cardiovascular and oncology development pipeline.
• Entered into a license and supply agreement to become the sourcing partner for Evofem Biosciences, Inc. (OTCQB: EVFM) for PHEXXI^® (lactic acid, citric acid and potassium bitartrate), a first-in-class hormone-free, on-demand prescription contraceptive vaginal gel that women control. The Company will leverage its manufacturing contacts to reduce pharmaceutical product cost of goods for PHEXXI.
• Regained Nasdaq compliance with the minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2) for continued listing. The Company will be subject to a mandatory panel monitor until March 20, 2026.
• Completed istaroxime cardiogenic shock national phase filings of patent applications around the world, including in the U.S., Germany, France, Italy, Japan and China. These filings claimed priority to PCT/US2023/018998 entitled, “Istaroxime-Containing Intravenous Formulation for the Treatment of Pre-Cardiogenic Shock and Cardiogenic Shock”.  This application is currently pending before the United States Patent and Trademark Office (USPTO), Application no. 18/858,086. Filed a new PCT patent application for istaroxime and its derivatives targeting the prevention of acute myocardial arrhythmias—building on encouraging data from clinical trials in acute heart failure and early cardiogenic shock, as well as preclinical models showing enhanced efficacy of istaroxime metabolites in improving cardiac function and reducing ischemia-induced arrhythmias.
• Received a Notice of Allowance from the USPTO for a patent covering an intravenous istaroxime formulation for acute heart failure, and filed a related patent application in India targeting the prevention of life-threatening arrhythmias in heart failure patients—further strengthening the company’s global intellectual property portfolio. Completed national phase filings for the istaroxime patent titled “ISTAROXIME-CONTAINING INTRAVENOUS FORMULATION FOR THE TREATMENT OF PRE-CARDIOGENIC SHOCK AND CARDIOGENIC SHOCK” (PCT/US2023/018998; U.S. Application No. 18/858,086) in key global markets including the U.S., Germany, France, Italy, Japan, and China—further strengthening international IP protection for its lead cardiovascular asset.
• Issued Japanese patent (No. 7603605, expiring 2040) for its novel aPKCi inhibitor platform targeting hedgehog pathway-dependent cancers—covering both topical and oral formulations, with potential applications in cancers such as basal cell carcinoma and small cell lung cancer, including use in combination therapies with HDAC inhibitors to enhance anti-cancer efficacy.
• Seeking to leverage positive Phase 2b results in early cardiogenic shock to secure non-dilutive funding through partnerships for istaroxime and next-generation oral SERCA2a activators outside Greater China; engaged New Growth Advisors to manage inbound interest and lead a broader out-licensing effort, while existing partner Lee’s Pharmaceuticals progresses toward a planned Phase 3 trial in acute heart failure in 1H 2025 under a deal worth up to $138 million in milestones plus royalties.
• Licensing partner Lee’s Pharmaceutical (HK) Ltd. is preparing to initiate a Phase 3 program for acute heart failure in Greater China, fully funding all development activities in the region; Windtree retains final protocol approval and is collaborating closely with Lee’s as it advances its global cardiogenic shock program in parallel.

Select 


2024


 Year-End Financial Results

Research and development (“R&D”) expenses were $16.3 million for the year ended December 31, 2024, compared to $8.3 million for the year ended December 31, 2023. The increase in research and development expenses is primarily due to (i) a $7.5 million charge related to acquired in-process R&D from the Varian asset purchase; and (ii) a $2.2 million increase in costs associated with the continued development of istaroxime, including the SEISMiC Extension study and start-up activities for the SEISMiC C study; partially offset by (iii) a $0.9 million reduction in royalty payments related to amendments to certain license agreements; (iv) a $0.6 million decrease in personnel costs due to headcount reductions; and (v) a $0.3 million decrease in non-cash stock-based compensation expense.

General and administrative expenses for the year ended December 31, 2024 were $8.7 million, compared to $9.2 million for the year ended December 31, 2023. The decrease in general and administrative expenses is primarily due to (i) a decrease of $0.6 million in non-cash stock-based compensation expense; (ii) a decrease of $0.4 million in personnel costs due to headcount reductions; (iii) a decrease of $0.3 million in severance expense related to a former executive; and (iv) a decrease of $0.4 million in insurance costs; partially offset by (v) an increase of $1.2 million in professional fees, primarily related to increased legal fees and costs associated with the July 2024 private placements.

For the year ended December 31, 2024, the Company reported a net loss of $1.8 million, compared to a net loss of $20.3 million for the year ended December 31, 2023. Net loss for the year ended December 31, 2024 includes a $14.4 million non-cash gain on debt extinguishment, a $10.5 million non-cash net gain related to the change in fair value of common stock warrant liability, and a non-cash loss on impairment of goodwill of $1.1 million. Net loss for the year ended December 31, 2023 includes a non-cash loss on impairment of goodwill of $3.1 million.

The Company reported a net loss attributable to common stockholders of $5.5 million ($104.35 per basic share) for the year ended December 31, 2024, which includes a deemed dividend of $3.6 million on the Series C Preferred Stock. Net loss attributable to common stockholders was $20.3 million ($4,718.74 per basic share) for the year ended December 31, 2023.

As of December 31, 2024, the Company reported cash and cash equivalents of $1.8 million. Subsequent to December 31, 2024, the Company (i) sold an additional 0.2 million shares of common stock under its equity line of credit purchase agreement for net proceeds of $1.5 million following mandatory redemption payments on our Series C preferred stock; (ii) received net proceeds of $0.3 million related to warrant exercises; and (iii) issued certain debt notes for aggregate net proceeds $0.5 million. As a result, the Company believes that it has sufficient resources available to fund its business operations through April 2025.  

Readers are referred to, and encouraged to read in its entirety, the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, which will be filed with the Securities and Exchange Commission on April 15, 2025 and includes detailed discussions about the Company’s business plans and operations, financial condition, and results of operations.

About Windtree Therapeutics

Windtree Therapeutics, Inc. is a biotechnology company focused on advancing early and late-stage innovative therapies for critical conditions and diseases. Windtree’s portfolio of product candidates includes istaroxime, a Phase II candidate with SERCA2a activating properties for acute heart failure and associated cardiogenic shock, preclinical SERCA2a activators for heart failure and preclinical precision aPKCi inhibitors that are being developed for potential in rare and broad oncology applications. Windtree also has a licensing business model with partnership out-licenses currently in place.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. The Company may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are based on information available to the Company as of the date of this press release and are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from the Company’s current expectations. Examples of such risks and uncertainties include: the Company’s ability to secure significant additional capital as and when needed; the Company’s ability to achieve the intended benefits of the aPKCi asset acquisition with Varian; risks and uncertainties associated with the success and advancement of the clinical development programs for istaroxime and the Company’s other product candidates, including preclinical oncology candidates; the Company’s ability to access the debt or equity markets; the Company’s ability to manage costs and execute on its operational and budget plans; the results, cost and timing of the Company’s clinical development programs, including any delays to such clinical trials relating to enrollment or site initiation; risks related to technology transfers to contract manufacturers and manufacturing development activities; delays encountered by the Company, contract manufacturers or suppliers in manufacturing drug products, drug substances, and other materials on a timely basis and in sufficient amounts; risks relating to rigorous regulatory requirements, including that: (i) the U.S. Food and Drug Administration or other regulatory authorities may not agree with the Company on matters raised during regulatory reviews, may require significant additional activities, or may not accept or may withhold or delay consideration of applications, or may not approve or may limit approval of the Company’s product candidates, and (ii) changes in the national or international political and regulatory environment may make it more difficult to gain regulatory approvals and risks related to the Company’s efforts to maintain and protect the patents and licenses related to its product candidates; risks that the Company may never realize the value of its intangible assets and have to incur future impairment charges; risks related to the size and growth potential of the markets for the Company’s product candidates, and the Company’s ability to service those markets; the Company’s ability to develop sales and marketing capabilities, whether alone or with potential future collaborators; the rate and degree of market acceptance of the Company’s product candidates, if approved; the economic and social consequences of the COVID-19 pandemic and the impacts of political unrest, including as a result of geopolitical tension, including the conflict between Russia and Ukraine, the People’s Republic of China and the Republic of China (Taiwan), and the evolving events in Israel and Gaza, and any sanctions, export controls or other restrictive actions that may be imposed by the United States and/or other countries which could have an adverse impact on the Company’s operations, including through disruption in supply chain or access to potential international clinical trial sites, and through disruption, instability and volatility in the global markets, which could have an adverse impact on the Company’s ability to access the capital markets. These and other risks are described in the Company’s periodic reports, including its Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, filed with or furnished to the Securities and Exchange Commission and available at www.sec.gov. Any forward-looking statements that the Company makes in this press release speak only as of the date of this press release. The Company assumes no obligation to update forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

Contact Information:

Eric Curtis
[email protected] 

WATERTOWN, Mass., April 15, 2025 (GLOBE NEWSWIRE) — Tectonic Therapeutic, Inc. (NASDAQ: TECX) (“Tectonic”), a clinical stage biotechnology company focused on the discovery and development of therapeutic proteins and antibodies that modulate the activity of G-protein coupled receptors (“GPCRs”), today announced that it will make a late-breaking oral presentation at the European Society of Cardiology (ESC) Heart Failure 2025 Congress. The presentation will highlight Phase 1b data for TX45, Tectonic’s lead asset and a long-acting relaxin therapy as a potential best-in-class therapy for patients with Group 2 PH-HFpEF. The presentation at ESC Heart Failure 2025 will include the full Phase 1b PH-HFpEF cohort results for TX45, expanding on the interim data previously announced by Tectonic on January 30, 2025.

ESC Heart Failure 2025 Presentation Details (being held in Belgrade, Serbia, May 17-20, 2025):

• Title: Hemodynamic effects of TX45 , a long-acting Fc-relaxin fusion, in Group 2 pulmonary hypertension patients.
• Presenter: Anthony Muslin, MD, Chief Development Officer
• Session: Late-breaking science in heart failure, cardiomyopathies, pulmonary hypertension, and valvular heart disease
• Session Date: Saturday, May 17, 2025
• Session Time: 4:40 p.m. Central European Time / 10:40 a.m. Eastern Time

About TX45, a long-acting Fc-relaxin fusion protein

TX45 is an Fc-relaxin fusion protein with optimized pharmacokinetics and biophysical properties that activates the RXFP1 receptor, the G-protein coupled receptor target of the hormone relaxin. Relaxin is an endogenous protein, expressed at low levels in both men and women that is a pulmonary and systemic vasodilator with lusitropic, anti-fibrotic and anti-inflammatory activity. In normal human physiology, relaxin is upregulated during pregnancy where it exerts vasodilative effects, reduces systemic and pulmonary vascular resistance and increases cardiac output to accommodate the increased demand for oxygen and nutrients from the developing fetus. Relaxin also exerts anti-fibrotic effects on pelvic ligaments to facilitate delivery of the baby.

About Group 2 Pulmonary Hypertension in HFpEF

The World Health Organization has defined 5 groups of pulmonary hypertension (“PH”). Tectonic is focused on the Group 2 subtype, a condition that develops due to left-sided heart disease, specifically Pulmonary Hypertension in Heart Failure with preserved Ejection Fraction (“PH-HFpEF”). In patients with PH-HFpEF, chronic heart failure leads to increased blood pressure in the pulmonary arteries, exerting severe strain on the right side of the heart, which adapts poorly to the increased pressure. This increased pulmonary pressure gradually causes worsening exercise capacity, shortness of breath and right-sided heart failure which can lead to death. PH-HFpEF is further segmented based on pulmonary hemodynamics into Isolated, post-capillary PH (“IpcPH”) and Combined pre- and post-capillary PH (“CpcPH”). CpcPH is more severe, accounts for about one third to one half of the 1.4 million PH-HFpEF patients in the U.S. and is characterized by additional, abnormal changes to the pulmonary vasculature, leading to an increase in Pulmonary Vascular Resistance (“PVR”). Although several Group 1 PH (Pulmonary Arterial Hypertension, “PAH”) medications have been explored in Group 2 PH, to date, no medications have been approved for its treatment.

About Tectonic

Tectonic Therapeutic is a clinical-stage biotechnology company focused on the discovery and development of therapeutic proteins and antibodies that modulate the activity of GPCRs. Leveraging its proprietary technology platform called GEODe™ (GPCRs Engineered for Optimal Discovery), Tectonic is focused on developing biologic medicines that overcome the existing challenges of GPCR-targeted drug discovery and harness the human body to modify the course of disease. Tectonic focuses on areas of significant unmet medical need, often where therapeutic options are poor or nonexistent, as these are areas where new medicines have the potential to improve patient quality of life. Tectonic is headquartered in Watertown, Massachusetts. For more information, please visit www.tectonictx.com and follow us on LinkedIn.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. All statements in this press release other than statements of historical facts are “forward-looking statements. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding the potential therapeutic benefit of TX45. These forward-looking statements are based on Tectonic’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties that could cause Tectonic’s clinical development programs, future results or performance to differ materially from those expressed or implied by the forward-looking statements. Many factors may cause differences between current expectations and actual results, including: the potential that success in preclinical testing and earlier clinical trials does not ensure that later clinical trials will generate the same results or otherwise provide adequate data to demonstrate the efficacy and safety of a product candidate; the impacts of macroeconomic conditions, including the conflict in Ukraine and the conflict in the Middle East, heightened inflation and uncertain credit and financial markets, on Tectonic’s business, clinical trials and financial position; unexpected safety or efficacy data observed during preclinical studies or clinical trials; clinical trial site activation or enrollment rates that are lower than expected; Tectonic’s ability to realize the benefits of its collaborations and license agreements; changes in expected or existing competition; changes in the regulatory environment; the uncertainties and timing of the regulatory approval process; and unexpected litigation or other disputes. Other factors that may cause Tectonic’s actual results to differ from those expressed or implied in the forward-looking statements in this press release are identified under the heading “Risk Factors” in Tectonic’s annual report on Form 10-K filed with the SEC on March 20, 2025, and in other filings that Tectonic makes and will make with the SEC in the future. Tectonic expressly disclaims any obligation to update any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law. For more information, please visit www.tectonictx.com and follow us on LinkedIn.