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CRANFORD, N.J. , Dec. 27, 2024 /PRNewswire/ -- Citius Oncology, Inc. ("Citius Oncology" or the "Company") (Nasdaq: CTOR), a specialty biopharmaceutical company focused on the development and commercialization of novel targeted oncology therapies, today reported business and financial results for the fiscal full year ended September 30, 2024 . Fiscal Full Year 2024 Business Highlights and Subsequent Developments Achieved U.S. Food and Drug Administration (FDA) approval of LYMPHIRTM (denileukin diftitox-cxdl), an immunotherapy for the treatment of adults with relapsed or refractory cutaneous T-cell lymphoma (CTCL); Began trading on the Nasdaq exchange under the ticker symbol CTOR on August 13, 2024 , following completion of the merger of Citius Pharma's oncology subsidiary with TenX Keane to form Citius Oncology, Inc., a standalone publicly traded company; Advanced manufacturing, marketing and sales activities in preparation for commercial launch of LYMPHIR in the first half of 2025; key activities included: Manufactured initial inventory for launch and finalized supply chain agreements, Initiated recruitment of targeted field force with contract sales organization, Launched a marketing awareness campaign and engaged with all leading CTCL prescribers, Applied for a unique J-code within the Healthcare Common Procedure Coding System (HCPCS) to facilitate accurate reimbursement, Secured inclusion of LYMPHIR in the National Comprehensive Cancer Network (NCCN) guidelines, critical to clinical decision-making in oncology and hematology, influencing treatment practices and payor reimbursement in the U.S., and Initiated development of the patient support center to help patients access LYMPHIR expeditiously; Supported two investigator-initiated trials to explore LYMPHIR's potential as an immuno-oncology combination therapy being conducted at the University of Pittsburgh Medical Center and the University of Minnesota ; and, Shared interim trial results with the clinical community at the Society for Immunotherapy of Cancer Conference (SITC) of University of Pittsburgh Medical Center's Phase I trial of LYMPHIR with checkpoint inhibitor pembrolizumab. The combination of these two immunomodulatory agents showed clinical benefit in relapsed or refractory gynecological neoplasms, resulting in: 27% objective response rate and 33% clinical benefit rate with median progression free survival of 57 weeks (range: 30-96 weeks), and A manageable safety profile whereby the regimen was well-tolerated with reversible treatment emergent adverse events and no definitive immune-related adverse events greater than or equal to grade 3 documented. Financial Highlights R&D expenses were $4.9 million for the full year ended September 30, 2024 , compared to $4.2 million for the full year ended September 30, 2023 ; G&A expenses were $8.1 million for the full year ended September 30, 2024 , compared to $5.9 million for the full year ended September 30, 2023 ; Stock-based compensation expense was $7.5 million for the full year ended September 30, 2024 , compared to $2.0 million for the full year ended September 30, 2023 ; and, Net loss was $21.1 million , or ($0.31) per share for the full year ended September 30, 2024 compared to a net loss of $12.7 million , or ($0.19) per share for the full year ended September 30, 2023 . "Reflecting on 2024, Citius Oncology has achieved pivotal milestones that underscore our commitment to advancing cancer therapeutics," stated Leonard Mazur , Chairman and CEO of Citius Oncology. "The FDA's approval of LYMPHIR for the treatment of cutaneous T-cell lymphoma marks a significant advancement in providing new options for patients battling this challenging disease. It is the only targeted systemic therapy approved for CTCL patients since 2018 and the only therapy with a mechanism of action that targets the IL-2 receptor. Additionally, the successful merger forming Citius Oncology, now trading on Nasdaq under the ticker CTOR, strengthens our position in the oncology sector. We expect it to facilitate greater access to capital to fund LYMPHIR's launch and the Company's future growth. With a Phase I investigator-initiated clinical trial combining LYMPHIR with pembrolizumab demonstrating promising preliminary results, indicating potential for enhanced treatment efficacy in recurrent solid tumors, and preliminary results expected from a second investigator trial with CAR-T therapies in 2025, we remain excited about the potential of LYMPHIR as a combination immunotherapy." "These accomplishments reflect the dedication of our team and the trust of our investors. As we look ahead, we remain steadfast in our mission to develop innovative therapies that improve the lives of cancer patients worldwide," added Mazur. FULL YEAR 2024 FINANCIAL RESULTS: Research and Development (R&D) Expenses R&D expenses were $4.9 million for the full year ended September 30, 2024 , compared to $4.2 million for the full year ended September 30, 2023 . The increase reflects development activities completed for the resubmission of the Biologics License Application of LYMPHIR in January 2024 , which were associated with the complete response letter remediation. General and Administrative (G&A) Expenses G&A expenses were $8.1 million for the full year ended September 30, 2024 , compared to $5.9 million for the full year ended September 30, 2023 . The increase was primarily due to costs associated with pre-commercial and commercial launch activities of LYMPHIR including market research, marketing, distribution and drug product reimbursement from health plans and payers. Stock-based Compensation Expense For the full year ended September 30, 2024 , stock-based compensation expense was $7.5 million as compared to $2.0 million for the prior year. The primary reason for the $5.5 million increase was due to the amounts being realized over 12 months in the year ended September 30, 2024 , as compared to three months post-plan adoption in the year ended September 30, 2023 . Net loss Net loss was $21.1 million , or ($0.31) per share for the year ended September 30, 2024 , compared to a net loss of $12.7 million , or ($0.19) per share for the year ended September 30, 2023 . The $8.5 million increase in net loss was primarily due to the increase in our operating expenses. About Citius Oncology, Inc. Citius Oncology specialty is a biopharmaceutical company focused on developing and commercializing novel targeted oncology therapies. In August 2024 , its primary asset, LYMPHIR, was approved by the FDA for the treatment of adults with relapsed or refractory CTCL who had had at least one prior systemic therapy. Management estimates the initial market for LYMPHIR currently exceeds $400 million , is growing, and is underserved by existing therapies. Robust intellectual property protections that span orphan drug designation, complex technology, trade secrets and pending patents for immuno-oncology use as a combination therapy with checkpoint inhibitors would further support Citius Oncology's competitive positioning. Citius Oncology is a publicly traded subsidiary of Citius Pharmaceuticals. For more information, please visit www.citiusonc.com Forward-Looking Statements This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements are made based on our expectations and beliefs concerning future events impacting Citius Oncology. You can identify these statements by the fact that they use words such as "will," "anticipate," "estimate," "expect," "plan," "should," and "may" and other words and terms of similar meaning or use of future dates. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated, and, unless noted otherwise, that apply to Citius Oncology are: our ability to raise additional money to fund our operations for at least the next 12 months as a going concern; our ability to commercialize LYMPHIR and any of our other product candidates that may be approved by the FDA; the estimated markets for our product candidates and the acceptance thereof by any market; the ability of our product candidates to impact the quality of life of our target patient populations; our dependence on third-party suppliers; our ability to procure cGMP commercial-scale supply; risks related to research using our assets but conducted by third parties; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; uncertainties relating to preclinical and clinical testing; market and other conditions; risks related to our growth strategy; patent and intellectual property matters; our ability to identify, acquire, close and integrate product candidates and companies successfully and on a timely basis; government regulation; competition; as well as other risks described in our Securities and Exchange Commission ("SEC") filings. These risks have been and may be further impacted by any future public health risks. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding our business are described in detail in our SEC filings which are available on the SEC's website at www.sec.gov , including in Citius Oncology's Annual Report on Form 10-K for the year ended September 30, 2024 , filed with the SEC on December 27, 2024 , as updated by our subsequent filings with the SEC. These forward-looking statements speak only as of the date hereof, and we expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law. Investor Contact: Ilanit Allen ir@citiuspharma.com 908-967-6677 x113 Media Contact: STiR-communications Greg Salsburg Greg@STiR-communications.com -- Financial Tables Follow – CITIUS ONCOLOGY, INC. CONSOLIDATED BALANCE SHEETS SEPTEMBER 30, 2024 AND 2023 2024 2023 Current Assets: Cash and cash equivalents $ 112 $ — Inventory 8,268,766 — Prepaid expenses 2,700,000 7,734,895 Total Current Assets 10,968,878 7,734,895 Other Assets: In-process research and development 73,400,000 40,000,000 Total Other Assets 73,400,000 40,000,000 Total Assets $ 84,368,878 $ 47,734,895 LIABILITIES AND STOCKHOLDERS' EQUITY Current Liabilities: Accounts payable $ 3,711,622 $ 1,289,045 License payable 28,400,000 — Accrued expenses — 259,071 Due to related party 588,806 19,499,119 Total Current Liabilities 32,700,429 21,047,235 Deferred tax liability 1,728,000 1,152,000 Note payable to related party 3,800,111 — Total Liabilities 38,228,540 22,199,235 Stockholders' Equity: Preferred stock - $0.0001 par value; 10,000,000 shares authorized: no shares issued and outstanding — — Common stock - $0.0001 par value; 100,000,000; 71,552,402 and 67,500,000 shares issued and outstanding at September 30, 2024 and 2023, respectively 7,155 6,750 Additional paid-in capital 85,411,771 43,658,750 Accumulated deficit (39,278,587) (18,129,840) Total Stockholders' Equity 46,140,339 25,535,660 Total Liabilities and Stockholders' Equity $ 84,368,878 $ 47,734,895 CITIUS ONCOLOGY, INC. CONSOLIDATED STATEMENTS OF OPERATIONS FOR THE YEARS ENDED SEPTEMBER 30, 2024 AND 2023 2024 2023 Revenues $ — $ — Operating Expenses: Research and development 4,925,001 4,240,451 General and administrative 8,148,929 5,915,290 Stock-based compensation – general and administrative 7,498,817 1,965,500 Total Operating Expenses 20,572,747 12,121,241 Loss before Income Taxes (20,572,747) (12,121,241) Income tax expense 576,000 576,000 Net Loss $ (21,148,747) $ (12,697,241) Net Loss Per Share – Basic and Diluted $ (0.31) $ (0.19) Weighted Average Common Shares Outstanding – Basic and Diluted 68,053,607 67,500,000 CITIUS ONCOLOGY, INC. CONSOLIDATED STATEMENTS OF CASH FLOWS FOR THE YEARS ENDED SEPTEMBER 30, 2024 AND 2023 2024 2023 Cash Flows From Operating Activities: Net loss $ (21,148,747) $ (12,697,241) Adjustments to reconcile net loss to net cash provided by operating activities: Stock-based compensation expense 7,498,817 1,965,500 Deferred income tax expense 576,000 576,000 Changes in operating assets and liabilities: Inventory (2,133,871) - Prepaid expenses (1,100,000) (5,044,713) Accounts payable 2,422,577 1,196,734 Accrued expenses (259,071) (801,754) Due to related party 14,270,648 14,805,474 Net Cash Provided By Operating Activities 126,353 - Cash Flows From Investing Activities: License payment (5,000,000) - Net Cash Used In Investing Activities (5,000,000) - Cash Flows From Financing Activities: Cash contributed by parent 3,827,944 - Merger, net (2,754,296) - Proceeds from issuance of note payable to related party 3,800,111 - Net Cash Provided By Financing Activities 4,873,759 - Net Change in Cash and Cash Equivalents 112 - Cash and Cash Equivalents – Beginning of Year - - Cash and Cash Equivalents – End of Year $ 112 $ - Supplemental Disclosures of Cash Flow Information and Non-cash Activities: IPR&D Milestones included in License Payable $ 28,400,000 $
Calgary-based company Ventori Energy Inc. is looking to build wind turbines in Valemount. In exchange for land where the turbines can be installed, the company would share 25 per cent of its revenue with the Village, the company’s vice president Sarah Scott said in a delegation to Valemount Council on November 26th. Ventori is a relatively new company, having been incorporated on April 24th, according to Alberta’s corporate registration system. However, Ventori’s sister companies – Australia-based ReVair and US-based Pascal – have both been incorporated for over a decade. Valemount is the first municipality to answer Ventori’s inquiries, Scott told The Goat. The company has not yet found a manufacturing plant to produce the turbine in Canada, but they are working on shipping prototypes from Australia, Scott said. The company has worked closely with Rudolph Oelofse, the inventor and patent-holder of their wind turbine, she said. According to court documents obtained by The Goat, Oelofse has been sued at least twice: once in 2018 for fraud, and again in 2021 for neglecting to pay the law firm he contracted to help him obtain patents. “For months, Oelofse and/or his agents made a variety of false promises and misrepresentations to [the] plaintiffs... including that they would receive a benefits and ownership interest in the technology and/or the company,” the 2018 suit filed against Oelofse reads. The 2018 plaintiffs opted to settle out of court, according to documents from the Superior Court of California in the County of Sacramento. The 2021 case was also dismissed by the court as neither party appeared at trial, according to documents from the Superior Court of California in the County of Orange. Scott declined to comment on either suit against Oelofse. During her delegation to Council, Scott outlined the company’s hopes for a wind energy project in Valemount, alongside Sales Director Teaken Blair. Installing wind turbines in Valemount could generate millions of dollars in revenue, according to Scott and Blair. The revenue would be split four ways between the Village, Ventori, Pascel, and another investor. According to Scott, the company has not found the fourth investor yet. Ventori staff estimate that each turbine could produce about $2M annually, so an installment of 50 turbines would amount to $100M/year, or about $24M per investor. While Valemount would receive the same portion of revenue as the other investors, the Village would not have to buy shares in the company, according to Scott and Blair. “We’re not expecting you guys to put any money into this – all we need is land,” Blair said. Scott and Blair said the type of turbines Ventori would produce – called Vertical Axis Wind Turbines, or VAWTs – are more compact, less noisy and better for local bird populations than traditional turbines. They are 60 feet tall and 40 feet wide, and constructed from an organic composite material which is significantly lighter and stronger than steel, according to the presentation. The turbines can last for up to 25 years with no maintenance, Blair said. Scott and Blair referenced a 2014 study titled “Institutional Perspectives on Small Wind Energy Permitting” as evidence of the turbines’ low impact on local bird populations. While the study largely focuses on comparing various local government policies on wind energy and does not focus on Oelofse’s patented turbines in particular, its section on bird ecology did conclude that VAWTs have a minimal impact on bird ecology and behaviour. The turbines would connect to a battery which would provide power to the Village, Blair said. According to him, this would allow the Village to move completely off-grid. After Scott and Blair’s presentation concluded, Council moved to receive the delegation. Councillor Hollie Blanchette asked how much it would cost to replace a turbine, and if the Village would be expected to cover that cost. “This is a really good question, because whose responsibility is it to replace the turbines? These are all questions that we’re still working out,” Scott said. “The way the agreement would work is that we are selling the energy, we’re not selling you the turbines.” Scott added that the company would establish a Power Purchase Agreement (PPA) – a type of contract between an electricity generator and a customer – with Valemount if the Village decided to strike a deal with Ventori. Councillor Pete Pearson asked if Ventori would need to build a substation to connect the wind energy turbines to the community power supply. “We wouldn’t necessarily need a substation for a small amount of turbines,” Blair said. “But you’re right, if we’re running a substantial amount of energy, then it wouldn’t work with just the batteries, we would need a substation. So it just depends on how many turbines we run.” Pearson asked if the Village could continue working with Independent Power Producers if it partnered with Ventori. “One of our philosophies is [that] we are looking to collaborate and cooperate with other existing forms of energy function,” Scott said. “We’re not asking you to cut it off at that, we want this to be an addition.” Mayor Owen Torgerson asked if the company has ever launched a project in B.C., or worked with BCHydro. Scott and Blair said they have not. “I would highly recommend you look at [Hydro’s] interconnection study procedures on what it means to connect to their grid,” Torgerson said. “I would also recommend looking at their standard offer program, which is their form of PPA... and have a serious look at what they require in order to attach to their grid.” Scott said the company would look into the standard offer program. Torgerson said the Village would not be able to assist in negotiating with BC Hydro. “We can advocate for a partnership, we can do a lot of things, but we certainly do not have the capacity to assist with a Power Purchase Agreement,” Torgerson said. In her interview with The Goat on Monday, December 2nd, Scott said the company had not yet looked into a standard offer program with BC Hydro, but it was on her to-do list for the upcoming week. “If the power source is done right, we won’t really need to tap into BC Hydro,” Scott added. “We won’t need to tap into the grid, but it will give the town of Valemount the option to sell [energy] back to the grid.” She said Ventori hopes to establish itself in small, mountainous communities like Valemount to provide energy and revenue to towns that may be struggling with rising costs of living. “I heard the skepticism in the Council’s voice when we were talking about this,” she said. “I think what we need to clarify is that the idea here is to help communities understand that they can be their own utility. That’s the goal: we want to empower towns like Valemount to understand they can be their own utility.”Ravens vs. Chargers live score, updates, highlights from NFL 'Monday Night Football' game | Sporting News
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ST. PAUL – Hunting pheasants, ruffed grouse, squirrels or rabbits offers Minnesota hunters opportunities to continue enjoying the outdoors as temperatures fall and snow blankets the landscape, the Department of Natural Resources said. Here’s a look at season dates for the small game species. ADVERTISEMENT Fisher, martin and bobcat trapping opens Saturday, Dec. 14, so hunters should be aware of the potential for additional traps in the woods. Hunters can find regulations and complete bag limit information on the DNR website at mndnr.gov/hunting . More information about how or where to hunt can be found on the DNR’s learn to hunt webpages at mndnr.gov/gohunting . Recorded webinars with tips on how to hunt pheasants, grouse, squirrels or rabbits are available in the webinar archive on the outdoor skills and stewardship page of the Minnesota DNR website at www.mndnr.gov/discover .Donald Trump's TikTok Standoff: Supreme Court Showdown
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Clintons urge voters agitated by today's politics to remain involved in public serviceAlamo Bowl live updates: Colorado vs. BYU time, TV, highlightsPedro escaped punishment after swinging an arm at Bees substitute substitute Yehor Yarmoliuk without making contact. VAR reviewed the second-half incident but deemed there was no violent conduct. Frank and Brighton head coach Fabian Hurzeler disagreed about the decision. “As I understand the rules, you can’t swing your arm to try to hit someone,” said Frank. “If you hit them or not, it’s a red, that’s the way I understand the rules.” Frank spoke to the match officials, including referee Andy Madley, about the flashpoint at full-time. “They haven’t seen the situation yet, not on TV afterwards,” said Frank. “To be fair to him, I think the angle can be tricky so that’s why you’ve got VAR.” Asked about Frank’s assessment, Hurzeler replied: “Interesting opinion. I see it completely different. “For me, it’s not a red card. He tried to get free from a person.” Brighton were booed off after their winless run was stretched to six top-flight games. Albion dominated for large periods and hit the woodwork inside four minutes through Julio Enciso. Bees goalkeeper Mark Flekken made some important saves before being forced off injured in the 36th minute, albeit his replacement Hakon Valdimarsson was rarely tested on his Premier League debut. The Seagulls remain 10th ahead of Monday’s trip to Aston Villa, with Brentford a position and two points below moving towards their New Year’s Day showdown with Arsenal. Hurzeler thought the jeers at full-time were unfair. “The team doesn’t deserve that because in all the games we had in the last weeks they were all good, they were all intense, they were all where we thought we deserved more” said the German, whose team have lost to Fulham and Crystal Palace and drawn with Southampton, Leicester and West Ham in recent matches. “We try to work hard to satisfy our supporters, we try to give them what they deserve, we try to make them proud. “But the Premier League is tough. We know there will be (tough) periods we have to go through, especially with this young squad. “We try to stick together, find the positive and keep on going.” Brentford, who remain without a top-flight away win this term, had an early Yoane Wissa finish ruled out for offside following VAR intervention but barely threatened, despite an improved second-half showing. Frank, who is awaiting news on Flekken and defender Ben Mee, who also left the field injured, said: “I thought it was a fair point. “Brighton were better in the first half, no big, clearcut chances, and I thought we were better second half. “Overall, I’m happy with the performance, especially the way we defended. “We haven’t had too many clean sheets this season, so in that context I thought it was very impressive against a good Brighton team. “We know we have a lot of players out – we get two more injuries during the game. “The way the players showed their mentality and character and dug in was hugely impressive.”
Decision follows observations of liver transaminitis without clinically significant symptoms in some subjects on azelaprag Company will evaluate data from patients enrolled to date and share updated plans for azelaprag in Q1 2025 In parallel to evaluating azelaprag, Company will continue to advance earlier platform-derived programs, including IND submission for CNS penetrant NLRP3 inhibitor anticipated in the second half of 2025 RICHMOND, Calif., Dec. 06, 2024 (GLOBE NEWSWIRE) -- BioAge Labs (Nasdaq: BIOA) (“BioAge”, “the Company”), a clinical-stage biopharmaceutical company developing therapeutic product candidates for metabolic diseases by targeting the biology of human aging, today announced that the Company has made the decision to discontinue the ongoing STRIDES Phase 2 study of its investigational drug candidate azelaprag as monotherapy and in combination with tirzepatide after liver transaminitis without clinically significant symptoms was observed in some subjects receiving azelaprag. No transaminase elevations were observed in the tirzepatide only treatment group. “Patient safety is our top priority in the conduct of our clinical studies,” said Kristen Fortney, PhD, CEO and co-founder of BioAge. “We made the difficult decision to discontinue the STRIDES Phase 2 study of azelaprag because it became clear that the emerging safety profile of the current doses tested is not consistent with our goal of a best-in-class oral obesity therapy. While this outcome is a significant disappointment, we remain encouraged by azelaprag’s promising preclinical and Ph1b efficacy profile. We remain committed to our focus on developing therapies for metabolic aging. In parallel to assessing the next steps for the azelaprag program, we will continue to advance our NLRP3 inhibitor program as well as additional research programs with novel mechanisms emerging from our platform.” STRIDES is a randomized, double-blind, placebo-controlled Phase 2 clinical trial of azelaprag as monotherapy and in combination with tirzepatide that planned to enroll approximately 220 individuals with obesity aged 55 years and older ( link ). The trial was designed to evaluate the efficacy as measured by body weight reduction and other outcomes, safety, and tolerability of two oral doses of azelaprag (300 mg, once or twice daily) in combination with tirzepatide (5 mg subcutaneous injection once weekly). An azelaprag monotherapy arm was included to provide additional safety information. Of 204 subjects enrolled in STRIDES as of today, 11 subjects in the azelaprag treatment groups were observed to have transaminase elevations with no clinically significant symptoms. Dosing of all subjects will be discontinued, and no additional subjects will be enrolled. Clinical follow-up of enrolled subjects will continue off drug. The Company intends to further analyze available STRIDES clinical data from all enrolled subjects. The Company has notified all study investigators and regulatory authorities including the U.S. Food and Drug Administration (FDA) of the Company’s decision to discontinue enrollment. The Company intends to share updated plans for azelaprag in Q1 2025. BioAge continues to advance its pipeline of therapeutic candidates targeting the biology of aging to treat metabolic diseases. The Company's novel class of brain-penetrant NLRP3 inhibitors, which have demonstrated high potency and a novel binding site, are progressing toward IND submission, anticipated in the second half of 2025. The NLRP3 inhibitor program targets neuroinflammation, which is linked to both metabolic and neurodegenerative diseases. In addition, BioAge is advancing multiple targets derived from its proprietary discovery platform, which analyzes molecular data spanning over 50 years of human aging trajectories. About BioAge Labs, Inc. BioAge is a clinical-stage biopharmaceutical company developing therapeutic product candidates for metabolic diseases, such as obesity, by targeting the biology of human aging. BioAge’s lead product candidate, azelaprag, is an orally available small molecule agonist of APJ that was observed to promote metabolism and prevent muscle atrophy on bed rest in a Phase 1b clinical trial. BioAge is also developing orally available small molecule brain penetrant NLRP3 inhibitors for the treatment of diseases driven by neuroinflammation. BioAge’s preclinical programs, based on novel insights from the company’s discovery platform built on human longevity data, address key pathways in metabolic aging. Forward-looking statements This press release contains “forward-looking statements” within the meaning of, and made pursuant to the safe harbor provisions of, the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding our plans to develop and commercialize our product candidates, our business strategy, results of our ongoing or planned clinical trials, the timing of any future updates to our programs and the clinical utility of our product candidates. These forward-looking statements may be accompanied by such words as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “might,” “plan,” “potential,” “possible,” “will,” “would,” and other words and terms of similar meaning. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including: our ability to develop, obtain regulatory approval for and commercialize our product candidates; the timing and results of preclinical studies and clinical trials; the risk that positive results in a preclinical study or clinical trial may not be replicated in subsequent trials or success in early stage clinical trials may not be predictive of results in later stage clinical trials; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; the occurrence of adverse safety events; failure to protect and enforce our intellectual property, and other proprietary rights; failure to successfully execute or realize the anticipated benefits of our strategic and growth initiatives; risks relating to technology failures or breaches; our dependence on collaborators and other third parties for the development of product candidates and other aspects of our business, which are outside of our full control; risks associated with current and potential delays, work stoppages, or supply chain disruptions; risks associated with current and potential future healthcare reforms; risks relating to attracting and retaining key personnel; failure to comply with legal and regulatory requirements; risks relating to access to capital and credit markets; and the other risks and uncertainties that are detailed under the heading “Risk Factors” included in BioAge’s Form 10-Q filed with the U.S. Securities and Exchange Commission (SEC) on November 7, 2024, and other filings with the SEC filed from time to time. BioAge undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. Contacts PR: Chris Patil, media@bioagelabs.com IR: Elena Liapounova, ir@bioagelabs.com Partnering: partnering@bioagelabs.com Web: https://bioagelabs.com