FDA may pull authorization for Pfizer COVID shot for kids under 5
The move would add another barrier for parents who want to vaccinate healthy children, as shots from Moderna and Novavax were approved for more limited populations.
In May, Health and Human Services Secretary Robert F. Kennedy Jr. said that the Centers for Disease Control and Prevention (CDC) would no longer recommend COVID-19 vaccines for healthy children or pregnant women.
The CDC then updated its immunization schedule to reflect that children with no underlying health condition 'may receive' COVID-19 vaccines after consulting with a health care provider — what's known as 'shared decision-making.'
If FDA pulls its emergency use authorization, Pfizer's vaccine would no longer be available to any children younger than 5. Right now, Moderna and Novavax shots could be administered 'off label' to healthy children.
'We are currently in discussions with the agency on potential paths forward and have requested that the EUA for this age group remain in place for the 2025-2026 season,' a Pfizer spokesman told The Hill.
'It is important to note that these deliberations are not related to the safety and efficacy of the vaccine which continues to demonstrate a favorable profile,' the company added.
The Guardian first reported on the FDA's potential move.
In a statement to The Hill, HHS said it wouldn't comment on potential changes.
'The COVID-19 pandemic ended with the expiration of the federal public health emergency in May 2023. We do not comment on potential, future regulatory changes. Unless officially announced by HHS, discussion about future agency action should be regarded as pure speculation,' HHS spokesman Andrew Nixon said.
Pfizer has had full FDA approval for its COVID-19 vaccine for individuals age 12 and older since 2022.
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NBC News
an hour ago
- NBC News
Hundreds of groups push back on Trump denying lawful immigrants access to Head Start, other programs
The Trump administration's expanded ban on immigrants' access to social services, such as Head Start and Meals on Wheels, could have a 'devastating' impact on children of immigrants, including U.S. citizens, hundreds of opponents told the federal government Wednesday. A total of 372 organizations have coalesced to oppose the administration's decision to make more federally funded health and human service programs off-limits to immigrants with some form of permission to be in the country. The groups say the administration wrongly promotes the expanded restrictions as part of its efforts to target illegal immigration. The policy actually 'directly targets lawfully present immigrants' by turning early learning centers, community health centers and mental health and addiction treatment programs 'into immigration checkpoints' where providers would have to check a person's immigration status, according to the groups. 'Undocumented immigrants already are not eligible for most federally funded programs. This is another case where the administration is lying to the public,' said Adriana Cadena, director of the Protecting Immigration Families coalition, which led the organizations' opposition to restrictions to be implemented by the Department of Health and Human Services (HHS). As a result, the restrictions will harm millions, the groups stated in official comments filed in response to the administration's expanded restrictions, published in the Federal Register July 14. The deadline for public comment on the new restrictions was set for 11:59 p.m. Wednesday. One in 4 children in the U.S. are in a family with at least one immigrant parent. In 2023, 86% of those children were born in the U.S., making them U.S. citizens, according to Migration Policy Institute, an immigration think tank. (President Donald Trump also wants to change such birthright citizenship.) Even if a U.S. citizen child is entitled to use a program, the Trump administration's restrictions are likely to cause confusion and misunderstanding, Cadena said, because of the many children who are in families whose members have different types of immigration status. "This is going to have long-term consequences we cannot begin to grasp," she said. In response to an NBC News request for comment, the White House sent a link to a July 10 news release by HHS announcing the new restrictions. The administration said in the release that it was ensuring that public benefits were not 'diverted to subsidize illegal aliens.' 'For too long, the government has diverted hardworking Americans' tax dollars to incentivize illegal immigration,' HHS Secretary Robert F. Kennedy, Jr., stated in the July 10 release. 'Today's action changes that — it restores integrity to federal social programs, enforces the rule of law, and protects vital resources for the American people.' Expanding the programs restricted to 'qualified' immigrants The 1996 Personal Responsibility Reconciliation Act restricted the eligibility for federal public benefits to certain 'qualified' immigrants, according to KFF, a health policy group. Qualified immigrants have been defined as those lawfully present in the U.S. and do not include people with Temporary Protected Status, those who have Deferred Action for Childhood Arrivals (DACA) and others, KFF reported. The HHS has added 13 more programs to the list of programs open only to qualified immigrants. Those newly added by the administration include Head Start, some of the funding for community health centers, family planning services, child welfare prevention, kinship guardian assistance, substance abuse prevention, treatment and recovery and mental health services and the Community Services Block Grant, the groups said. The federal government has said the list is not comprehensive and more programs could be added later. The groups argue that the programs and immigrants' access to them have a larger benefit to society as a whole and that "reducing access to these vital programs will make all of our communities less healthy, less safe, less stable, less able to thrive." Restrictions on the HHS programs announced in July were to be effective immediately. Groups said little guidance has been given to providers regarding their implementation, creating confusion and having a chilling effect on people who are eligible for the programs and benefits as well as on the nonprofits, local governments and others who provide them. Several states have sued over the changes, which they said would also affect programs such as Meals on Wheels, domestic violence shelters, housing assistance and more. A lawsuit also was filed by the American Civil Liberties Union and others on behalf of parent groups challenging Trump's policies on Head Start. The administration provided a 30-day comment period for the new restrictions. "We do not necessarily expect that there is a real interest from the administration to seek comment on public policy that will impact millions of people," Cadena said. "This is all about the Trump administration's governmentwide attack on immigrant families, and to dismantle the safety net system that many Americans rely on," she said.
Yahoo
an hour ago
- Yahoo
Opus Genetics Announces Financial Results for Second Quarter 2025 and Provides Corporate Update
- Positive 12-month Phase 1/2 clinical data in adult cohort and early pediatric clinical data support potential for meaningful vision restoration with OPGx-LCA5 -- FDA grants Regenerative Medicine Advanced Therapy (RMAT) designation for OPGx-LCA5 - - Positive topline results reported from VEGA-3 and LYNX-2 Phase 3 trials with Phentolamine Ophthalmic Solution 0.75% - - OPGx-BEST1 on track to enter Phase 1/2 trial in H2 2025 for the treatment of bestrophin-1 related inherited retinal disease - - Non-dilutive funding from patient advocacy groups secured to advance multiple early-stage gene therapy programs - RESEARCH TRIANGLE PARK, N.C., Aug. 13, 2025 (GLOBE NEWSWIRE) -- Opus Genetics, Inc. (Nasdaq: IRD) (the 'Company' or 'Opus Genetics'), a clinical-stage biopharmaceutical company developing gene therapies for the treatment of inherited retinal diseases (IRDs) and small molecule therapies for other ophthalmic disorders, today announced financial results for the second quarter ended June 30, 2025, and provided a corporate update. 'We've made significant progress across our pipeline, with multiple clinical and regulatory milestones achieved this quarter,' said George Magrath, M.D., Chief Executive Officer, Opus Genetics. 'Receiving RMAT designation for our OPGx-LCA5 program underscores the strength of our clinical data and the urgent need for effective gene therapies to treat inherited retinal diseases. We are encouraged by the sustained functional vision improvements observed in adult patients in our clinical trial to date and the early signs of efficacy in the pediatric cohort. In parallel, our advancement of OPGx-BEST1 toward the clinic and the nomination of two additional development candidates in partnership with the Retinal Degeneration Fund and the Global RDH12 Alliance highlight the breadth of our IRD pipeline.' 'Beyond gene therapy, the positive readouts from our two Phase 3 Phentolamine trials represent a major step toward our goal of bringing a new treatment option to millions of patients living with vision challenges. With several upcoming key milestones, including new clinical data, a supplemental New Drug Application (sNDA) submission, and the launch of a pivotal study, we remain focused on execution to deliver transformative treatments to patients with significant unmet needs,' Dr. Magrath concluded. Pipeline Updates OPGx-LCA5 – Gene Therapy for Leber Congenital Amaurosis (LCA) The U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation for OPGx-LCA5, for the treatment of Leber Congenital Amaurosis (LCA) due to genetic variations in the LCA5 gene, signifying the program's potential to address a serious condition and providing a pathway for accelerated development and review. Twelve-month clinical data from adult participants in the Phase 1/2 trial demonstrated sustained improvements in visual function, including visual acuity gains and improved mobility testing scores. This data was presented at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting in May. Initial pediatric data at one-month post-treatment showed vision improvement with no drug-related adverse events; three-month pediatric data is expected to be reported in Q3 2025. OPGx-BEST1 – Gene Therapy for BEST1-Related IRD Preclinical data presented at the American Ophthalmological Society (AOS) in May demonstrated restoration of the retinal pigment epithelium-photoreceptor interface in a canine model of BEST1 using AAV-mediated gene delivery. Investigational New Drug (IND) submission and Phase 1/2 trial initiation remain on track for the second half of 2025. OPGx-RDH12 and OPGx-MERTK – Advancing with Non-Dilutive Support Partnership with the Global RDH12 Alliance provides up to $1.6 million in non-dilutive funding to accelerate development of OPGx-RDH12 for Leber congenital amaurosis (RDH12-LCA). Non-dilutive funding up to $2 million received from the Retinal Degeneration Fund to advance OPGx-MERTK, targeting retinitis pigmentosa caused by MERTK mutations. Preclinical OPGx-MERTK data presented at the American Society of Gene & Cell Therapy (ASGCT) in May showed preservation of retinal function in animal models. Phentolamine Ophthalmic Solution 0.75% – Advancing Toward sNDA Submissions VEGA-3 Phase 3 trial met its primary and multiple secondary endpoints in presbyopia, with 27.2% of treated patients achieving a ≥15-letter gain in near visual acuity (vs. 11.5% on placebo, p<0.0001) and favorable participant reported outcomes and safety profile. LYNX-2 Phase 3 trial met its primary and multiple secondary endpoints in keratorefractive patients with night vision disturbances. Patients showed statistically significant gains in mesopic low contrast vision and improvements in night-driving related symptoms. sNDA submission for presbyopia indication planned for the second half of 2025. LYNX-3 Phase 3 trial expected to initiate enrollment in the second half of 2025 targeting reduced low light vision and nighttime visual disturbances. Additional Medical Meeting Presentations Virtual reality-guided functional testing to support meaningful clinical endpoints in IRD trials was presented at the Retinal Imaging Biomarkers Summit. Upcoming Expected Data Readouts and Program Advancements Report three-month pediatric data from OPGx-LCA5 Phase 1/2 trial in Q3 2025. Initiate enrollment in Phase 1/2 trial for OPGx-BEST1 in H2 2025. Submit Phentolamine sNDA for presbyopia in H2 2025. Initiate enrollment in Phentolamine LYNX-3 Phase 3 trial in H2 2025. Financial Results for the Second Quarter Ended June 30, 2025 Cash Position: As of June 30, 2025, Opus Genetics had cash and cash equivalents of $32.4 million. Based on current operating plans, the Company expects its existing cash resources will fund operations into the second half of 2026. Revenue: License and collaboration revenue totaled $2.9 million for the second quarter of 2025, compared to $1.1 million in the same period in 2024. Revenue in both periods was driven by the Company's collaboration with Viatris, Inc., primarily from reimbursement of R&D services. General and Administrative (G&A) Expenses: G&A expenses were $5.8 million for the second quarter of 2025, compared to $3.4 million for the same period in 2024. The increase was mainly due to higher costs associated with legal and patent-related expenses, payroll, and business development activities. G&A expenses included $0.6 million and $0.5 million in stock-based compensation in the second quarters of 2025 and 2024, respectively. Research and Development (R&D) Expenses: R&D expenses were $6.0 million for the second quarter of 2025, compared to $6.1 million in the prior-year period. The slight decrease was primarily due to lower manufacturing and consulting costs, partially offset by increased clinical trial, toxicology, and payroll-related expenses. R&D expenses related to Phentolamine Ophthalmic Solution 0.75% were fully reimbursed under the Viatris License Agreement. Stock-based compensation within R&D expenses was $0.3 million in both periods. Net Loss: Net loss for the second quarter of 2025 was $7.4 million, or $(0.12) per basic and diluted share, compared to a net loss of $7.8 million, or $(0.30) per basic and diluted share, for the second quarter of 2024. SEC Filing: Additional details on the Company's financial results will be available in its Quarterly Report on Form 10-Q for the period ended June 30, 2025, to be filed with the U.S. Securities and Exchange Commission (SEC). About Opus Genetics Opus Genetics is a clinical-stage biopharmaceutical company developing gene therapies for the treatment of inherited retinal diseases (IRDs) and small molecule therapies for other ophthalmic disorders. The Company's pipeline features AAV-based gene therapies targeting inherited retinal diseases including Leber congenital amaurosis (LCA), bestrophinopathy, and retinitis pigmentosa. Its lead gene therapy candidates are OPGx-LCA5, which is in an ongoing Phase 1/2 trial for LCA5-related mutations, and OPGx-BEST1, a gene therapy targeting BEST1-related retinal degeneration. Opus is also advancing Phentolamine Ophthalmic Solution 0.75%, a partnered therapy currently approved in one indication and being studied in two Phase 3 programs for presbyopia and reduced low light vision and nighttime visual disturbances. The Company is based in Research Triangle Park, NC. For more information, visit Forward Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements related to cash runway, the clinical development, clinical results, preclinical data, and future plans for Phentolamine Ophthalmic Solution 0.75%, OPGx-LCA5, OPGx-BEST1, RDH12, and earlier stage programs, and expectations regarding us, our business prospects, and our results of operations and are subject to certain risks and uncertainties posed by many factors and events that could cause our actual business, prospects and results of operations to differ materially from those anticipated by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those described under the heading 'Risk Factors' included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and in our other filings with the U.S. Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. These forward-looking statements are based upon our current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties. In some cases, you can identify forward-looking statements by the following words: 'anticipate,' 'believe,' 'continue,' 'could,' 'estimate,' 'expect,' 'intend,' 'aim,' 'may,' 'ongoing,' 'plan,' 'potential,' 'predict,' 'project,' 'should,' 'will,' 'would' or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. We undertake no obligation to revise any forward-looking statements in order to reflect events or circumstances that might subsequently arise. Contacts: InvestorsJenny KobinRemy BernardaIR Advisory Solutionsir@ MediaKimberly HaKKH Opus Genetics, Consolidated Balance Sheets(in thousands, except share amounts and par value) As of June 30, December 31, 2025 2024 Assets (Unaudited) Current assets: Cash and cash equivalents $ 32,429 $ 30,321 Accounts receivable 3,399 3,563 Contract assets and unbilled receivables 1,178 2,209 Prepaids and other current assets 1,433 515 Short-term investments — 2 Total current assets 38,439 36,610 Property and equipment, net 226 252 Total assets $ 38,665 $ 36,862 Liabilities and stockholders' equity Current liabilities: Accounts payable $ 1,465 $ 3,148 Accrued expenses and other liabilities 6,927 8,147 Warrant liabilities 11,800 — Total current liabilities 20,192 11,295 Long-term funding agreement, related party 1,000 — Total liabilities 21,192 11,295 Commitments and contingencies Series A preferred stock, par value $0.0001; 14,146 shares were designated as of June 30, 2025 and December 31, 2024; zero and 14,145.374 shares issued and outstanding at June 30, 2025 and December 31, 2024, respectively. — 18,843 Stockholders' equity: Preferred stock, par value $0.0001; 9,985,854 shares authorized as of June 30, 2025 and December 31, 2024; no shares issued and outstanding at June 30, 2025 and December 31, 2024. — — Common stock, par value $0.0001; 125,000,000 shares authorized as of June 30, 2025 and December 31, 2024; 59,908,055 and 31,574,657 shares issued and outstanding at June 30, 2025 and December 31, 2024, respectively. 6 3 Additional paid-in capital 172,079 145,719 Accumulated deficit (154,612 ) (138,998 ) Total stockholders' equity 17,473 6,724 Total liabilities, series A preferred stock and stockholders' equity $ 38,665 $ 36,862 Opus Genetics, Consolidated Statements of Comprehensive Loss(in thousands, except share and per share amounts)(Unaudited) For the Three Months EndedJune 30, For the Six Months EndedJune 30, 2025 2024 2025 2024 License and collaborations revenue $ 2,882 $ 1,112 $ 7,252 $ 2,823 Operating expenses: General and administrative 5,766 3,354 12,112 8,024 Research and development 6,022 6,086 13,975 10,835 Total operating expenses 11,788 9,440 26,087 18,859 Loss from operations (8,906 ) (8,328 ) (18,835 ) (16,036 ) Fair value change in warrant and other derivative liabilities 917 — 3,722 — Financing costs 35 — (1,337 ) — Other income, net 534 563 836 1,165 Loss before income taxes (7,420 ) (7,765 ) (15,614 ) (14,871 ) Benefit (provision) for income taxes — — — — Net loss (7,420 ) (7,765 ) (15,614 ) (14,871 ) Other comprehensive loss, net of tax — — Comprehensive loss $ (7,420 ) $ (7,765 ) $ (15,614 ) $ (14,871 ) Net loss per share: Basic and diluted $ (0.12 ) $ (0.30 ) $ (0.32 ) $ (0.59 ) Number of shares used in per share calculations: Basic and diluted 63,376,392 25,827,265 48,712,124 25,175,596 Source: Opus Genetics, in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
an hour ago
- Business Wire
Lantern Pharma Reports Second Quarter 2025 Financial Results and Business Updates
DALLAS--(BUSINESS WIRE)--Lantern Pharma Inc. (NASDAQ: LTRN), a clinical-stage biopharmaceutical company leveraging its proprietary RADR® artificial intelligence (AI) and machine learning (ML) platform to transform the cost, pace, and timeline of oncology drug discovery and development, today announced operational highlights and financial results for the second quarter 2025 ended June 30, 2025, and provided an update on its portfolio of AI-driven drug candidates and AI platform, RADR®. ' This quarter we observed complete responses in patients across two of our clinical trials, delivering meaningful patient benefit and providing further validation of both the mechanisms and therapeutic potential of our drug candidates, ' said Panna Sharma, CEO & President of Lantern Pharma. Simultaneously, our team is transforming our AI platform into functional, accessible modules for the broader oncology community. These parallel advances mark a pivotal inflection point in our clinical and technological evolution, reinforcing our fiscally disciplined, AI-driven approach to addressing critical unmet patient needs with a clear pathway to commercialization and value creation. ' Clinical Pipeline Developments LP-184: Successful Completion of Enrollment for Phase 1a & Advancing Toward Phase 1b/2 Studies Lantern successfully completed enrollment of its LP-184 Phase 1a first-in-human trial with 65 patients across multiple solid tumor indications. The trial established both the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), positioning LP-184 for advancement of planned Phase 1b/2 studies in indications with large multi-billion dollar annual market potential, including recurrent TNBC and recurrent bladder cancer. LP-184 has received Fast Track Designations from the FDA for both glioblastoma multiforme (GBM) and triple negative breast cancer (TNBC), along with four Rare Pediatric Disease Designations for hepatoblastoma, rhabdomyosarcoma, malignant rhabdoid tumors, and atypical teratoid rhabdoid tumors (ATRT). Through its wholly-owned subsidiary Starlight Therapeutics, Lantern is developing LP-184 as STAR-001 for central nervous system cancers. During the quarter, Lantern announced findings from independent research conducted at Johns Hopkins validating Lantern's data used to secure the FDA Rare Pediatric Disease Designation for LP-184 in ATRT and support planned pediatric clinical trials. The data demonstrated that LP-184, a next-generation acylfulvene clinical-stage drug candidate, significantly extended survival in mouse models of ATRT. In the CHLA06 model, median survival increased from 20 days in the control group to 89 days in the LP-184 treatment group, representing a 345% improvement (p<0.0001). In the BT37 model, median survival increased from 68 days to 98 days (p=0.0422). LP-184 is a next-generation acylfulvene drug candidate, a synthetic small molecule belonging to a class of naturally-derived anti-cancer agents. LP-184 works by preferentially damaging DNA in cancer cells that overexpress specific biomarkers or that harbor mutations in DNA damage repair pathways. LP-184 is the product of years of research, including insights from RADR ®, Lantern's proprietary AI platform that leverages over 200 billion oncology-focused data points. LP-184 is a prodrug that is converted to its bioactive form inside the cancer cell by PTGR1 (prostaglandin reductase 1), an enzyme that is overexpressed in certain cancers. Once activated, LP-184 creates cytotoxic metabolites that form adducts with DNA, leading to irreparable DNA damage and ultimately tumor cell death. LP-300 HARMONIC™ Trial: Complete Response Observed Demonstrating Clinical Activity & Successful Completion of Enrollment in Japan The Phase 2 HARMONIC™ trial continues to advance with enrollment across the United States and expansion sites in Asia. A remarkable complete response was observed in a 70-year-old never-smoker patient with advanced NSCLC who had exhausted three prior treatment regimens. This outcome builds on previously reported data showing an 86% clinical benefit rate and 43% objective response rate in the initial safety lead-in cohort. Additionally the Phase 2 HARMONIC™ trial made advancements in Asia with completion of the Japanese cohort of 10 patients. Multiple centers in Japan participated in the clinical trial including The National Cancer Center Tokyo. The study is strategically positioned in regions with high prevalence of never-smoker lung cancer patients, with active sites in Taiwan where over 40% of new lung cancer diagnoses occur in never-smokers. Additional clinical data and findings are anticipated in September 2025, including initial safety and response evaluations from the Asian expansion cohort. The treatment of never-smokers with NSCLC represents a market opportunity estimated at over $4 billion annually. There are no approved therapies specifically targeted at the treatment of never-smokers with NSCLC currently. Lantern is actively exploring collaboration and partnering opportunities to maximize LP-300's commercial potential in multiple geographies. LP-284: Phase 1a Clinical Trial in Refractory Lymphoma Observed a Complete Response LP-284 exhibited remarkable clinical activity in a heavily pretreated 41-year-old patient with aggressive Grade 3 diffuse large B-cell lymphoma (DLBCL). Following failure of standard R-CHOP/Pola-R-CHP chemotherapy, CAR-T cell therapy (liso-cel), and CD3xCD20 bispecific antibody therapy (glofitamab), the patient achieved complete metabolic response with non-avid lesions after completing just two doses of LP-284. This represents the first complete response observed with LP-284. The complete response provides support to the mechanistic rationale and the potential for further future clinical activity in one of the most therapeutically challenging hematological malignancies. Lantern believes that this supports LP-284's synthetic lethal mechanism and potential paradigm-shifting role in treating refractory aggressive lymphomas. The complete metabolic response achievement positions LP-284 to seek a future role within a global blood cancer market focused on B-cell cancer that is estimated at $4 billion annually, with DLBCL representing the largest aggressive lymphoma subtype affecting approximately 200,000 patients globally each year. The critical unmet need in refractory/relapsed settings represents a substantial commercial opportunity for innovative therapeutic approaches that can deliver meaningful clinical benefit to therapeutically exhausted patient populations. Intellectual Property Advancements Lantern significantly strengthened its global intellectual property portfolio during the second quarter with two major patent developments: European Patent Allowance for LP-284: The European Patent Office (EPO) issued a notice of allowance for a composition of matter patent covering LP-284, expected to be granted with exclusivity through early 2039. This EU patent complements existing composition of matter patents granted in the U.S. (April 2023) and Japan (June 2024), with additional patent allowances in India and Mexico, and applications pending in China, Australia, Canada, and Korea. This expanding international IP portfolio positions LP-284 for global commercialization and strategic partnerships. Blood-Brain Barrier Prediction Patent Application: Lantern announced the publication of its PCT patent application (PCT/US2024/019851) covering a novel machine learning solution for predicting blood-brain barrier (BBB) permeability, which received a favorable PCT search report indicating no significant prior art. The technology powering predictBBB™ demonstrates exceptional performance, processing up to 100,000 molecules per hour with industry-leading accuracy. Lantern's AI algorithms currently hold five of the top eleven positions on the Therapeutic Data Commons Leaderboard. The PCT application, if granted, will enable multi-country patent protection for 20 years from the filing date. RADR ® AI Platform Enhancements Lantern continues to expand the capabilities of its RADR ® platform, which now leverages over 200 billion oncology-focused data points and a library of 200+ advanced machine learning algorithms. Key enhancements this quarter include: Module Public Launch: The public release of an AI module for predicting blood-brain barrier permeability with 94% prediction accuracy, 95% sensitivity and 89% specificity. This addresses a critical pharmaceutical development challenge where only 2-6% of small-molecule drugs can successfully cross the blood-brain barrier. Drug Combination Prediction Module: An innovative AI-powered module to improve prediction of synergistic cancer drug combinations, with framework and analytics based on peer-reviewed research. The module focuses initially on DNA damaging agents and DNA repair inhibitors, aimed at a market opportunity where approximately $50 billion is spent annually on the development of combination therapies for cancer. The AI module, trained on 221 clinical trials, will be incorporated as part of Lantern's AI platform, RADR®, and will initially focus on tailored combinations of DNA damaging agents and DNA repair inhibitors. The framework and foundational data for the module was published in a peer-reviewed study published in Frontiers in Oncology, ' Clinical outcomes of DNA-damaging agents and DNA damage response inhibitors combinations in cancer: a data-driven review '. The company plans to make select RADR ® modules available to the broader scientific and research community, fostering collaborative, open-source innovation in oncology drug development while creating potential new revenue streams. Financial Results for Second Quarter 2025 Balance Sheet: Cash, cash equivalents, and marketable securities were approximately $15.9 million as of June 30, 2025, compared to approximately $24.0 million as of December 31, 2024. The company believes that its existing cash, cash equivalents, and marketable securities as of June 30, 2025 and anticipated expenditures will enable funding of operating expenses and capital expenditure requirements at least into June 2026. Research and Development Expenses: R&D expenses were approximately $3.1 million for the quarter ended June 30, 2025, compared to approximately $3.9 million for the quarter ended June 30, 2024, reflecting continued disciplined cost management while advancing multiple clinical programs. General and Administrative Expenses: G&A expenses were approximately $1.6 million for the quarter ended June 30, 2025, compared to approximately $1.5 million for the quarter ended June 30, 2024. Net Loss: Net loss was approximately $4.33 million (or $0.40 per share) for the quarter ended June 30, 2025, compared to a net loss of approximately $4.96 million (or $0.46 per share) for the quarter ended June 30, 2024. Capitalization: As of June 30, 2025, the Company had 10,784,725 shares of common stock outstanding, and options to purchase 1,239,766 shares of common stock at a weighted average exercise price of $5.72 per share were outstanding. There were no outstanding warrants as of June 30, 2025. Quarterly Earnings Calls: Lantern has determined not to host a quarterly earnings call at the present time given the concentration of resources required for a live video based webinar style call. In addition to quarterly press releases with earnings information, and more frequent updates regarding the progress of our portfolio and platform, we plan to focus our resources on other distribution channels that we believe will be more effective in conveying information to stockholders, including webinars, digital media resources and broader social media channels. June 30, 2025 December 31, 2024 (Unaudited) CURRENT ASSETS Cash and cash equivalents $ 6,061,408 $ 7,511,079 Marketable securities 9,840,366 16,501,984 Prepaid expenses & other current assets 1,299,016 1,234,566 Total current assets 17,200,790 25,247,629 Property and equipment, net 39,524 47,440 Operating lease right-of-use assets 143,240 239,985 Other assets 36,738 36,738 TOTAL ASSETS $ 17,420,292 $ 25,571,792 CURRENT LIABILITIES Accounts payable and accrued expenses $ 4,752,848 $ 4,140,361 Operating lease liabilities, current 131,515 190,814 Total current liabilities 4,884,363 4,331,175 Operating lease liabilities, net of current portion 13,524 52,843 TOTAL LIABILITIES 4,897,887 4,384,018 COMMITMENTS AND CONTINGENCIES (NOTE 4) STOCKHOLDERS' EQUITY Preferred Stock (1,000,000 authorized at June 30, 2025 and December 31, 2024; $.0001 par value) (Zero shares issued and outstanding at June 30, 2025 and December 31, 2024) - - Common Stock (25,000,000 authorized at June 30, 2025 and December 31, 2024; $.0001 par value) (10,784,725 shares issued and outstanding at June 30, 2025 and December 31, 2024) 1,078 1,078 Additional paid-in capital 97,366,699 97,058,323 Accumulated other comprehensive income 48,043 153,990 Accumulated deficit (84,893,415 ) (76,025,617 ) Total stockholders' equity 12,522,405 21,187,774 TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ $ 25,571,792 Expand About Lantern Pharma Lantern Pharma (NASDAQ: LTRN) is an AI company transforming the cost, pace, and timeline of oncology drug discovery and development. Our proprietary AI and machine learning (ML) platform, RADR®, leverages over 200 billion oncology-focused data points and a library of 200+ advanced ML algorithms to help solve billion-dollar, real-world problems in oncology drug development. By harnessing the power of AI and with input from world-class scientific advisors and collaborators, we have accelerated the development of our growing pipeline of drug candidates that span multiple cancer indications, including both solid tumors and blood cancers and an antibody-drug conjugate (ADC) program. On average, our newly developed drug programs have been advanced from initial AI insights to first-in-human clinical trials in 2-3 years and at approximately $1.0 - 2.5 million per program. Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include, among other things, statements relating to: future events or our future financial performance; the potential advantages of our RADR ® platform in identifying drug candidates and patient populations that are likely to respond to a drug candidate; our strategic plans to advance the development of our drug candidates and antibody drug conjugate (ADC) development program; estimates regarding the development timing for our drug candidates and ADC development program; expectations and estimates regarding clinical trial timing and patient enrollment; our research and development efforts of our internal drug discovery programs and the utilization of our RADR ® platform to streamline the drug development process; our intention to leverage artificial intelligence, machine learning and genomic data to streamline and transform the pace, risk and cost of oncology drug discovery and development and to identify patient populations that would likely respond to a drug candidate; estimates regarding patient populations, potential markets and potential market sizes; sales estimates for our drug candidates and our plans to discover and develop drug candidates and to maximize their commercial potential by advancing such drug candidates ourselves or in collaboration with others. Any statements that are not statements of historical fact (including, without limitation, statements that use words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "model," "objective," "aim," "upcoming," "should," "will," "would," or the negative of these words or other similar expressions) should be considered forward-looking statements. There are a number of important factors that could cause our actual results to differ materially from those indicated by the forward-looking statements, such as (i) the risk that we may not be able to secure sufficient future funding when needed and as required to advance and support our existing and planned clinical trials and operations, (ii) the risk that observations in preclinical studies and early or preliminary observations in clinical studies do not ensure that later observations, studies and development will be consistent or successful, (iii) the risk that our research and the research of our collaborators may not be successful, (iv) the risk that we may not be successful in licensing potential candidates or in completing potential partnerships and collaborations, (v) the risk that none of our product candidates has received FDA marketing approval, and we may not be able to successfully initiate, conduct, or conclude clinical testing for or obtain marketing approval for our product candidates, (vi) the risk that no drug product based on our proprietary RADR ® AI platform has received FDA marketing approval or otherwise been incorporated into a commercial product, and (vii) those other factors set forth in the Risk Factors section in our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission on March 27, 2025. You may access our Annual Report on Form 10-K for the year ended December 31, 2024 under the investor SEC filings tab of our website at or on the SEC's website at Given these risks and uncertainties, we can give no assurances that our forward-looking statements will prove to be accurate, or that any other results or events projected or contemplated by our forward-looking statements will in fact occur, and we caution investors not to place undue reliance on these statements. All forward-looking statements in this press release represent our judgment as of the date hereof, and, except as otherwise required by law, we disclaim any obligation to update any forward-looking statements to conform the statement to actual results or changes in our expectations. Lantern Pharma Disclosure Channels to Disseminate Information: Lantern Pharma's investors and others should note that we announce material information to the public about our company and its technologies, clinical developments, licensing matters and other matters through a variety of means, including Lantern Pharma's website, press releases, SEC filings, digital newsletters, and social media, in order to achieve broad, non-exclusionary distribution of information to the public. We encourage our investors and others to review the information we make public in the locations above as such information could be deemed to be material information. Please note that this list may be updated from time to time.
