ReShape Lifesciences® Receives Notice of Allowance for U.S. Patent Related to Its Proprietary Diabetes Neuromodulation Technology
'Allowance for this newest patent, on the heels of the recently announced Israeli patent, serves as strong evidence of the promise of this groundbreaking technology, which has shown the potential to reduce dependence on medications for diabetics through a personalized approach. By optimizing glucose control, the technology aims to lower treatment costs and minimize complications related to poorly managed blood sugar and medication non-compliance,' stated Paul F. Hickey, President and Chief Executive Officer of ReShape Lifesciences®. 'Like other patent families within ReShape, the Diabetes Neuromodulation technology is supported by a robust intellectual property portfolio, comprising 62 issued or pending patents. These cover vagal neuromodulation, glucose control, AI, and Bluetooth applications, ensuring a clear path to commercialization while providing strong protection against competitive threats.'
'Type 2 diabetes is a worldwide issue and continues to be difficult to treat effectively, despite the availability of medication, surgery, and dietary interventions,' stated Jonathan Waataja, Ph.D. Director of Research at ReShape Lifesciences. 'ReShape's Diabetes Neuromodulation technology regulates blood glucose by selectively modulating vagal block and stimulation to the liver and pancreas. Studies have shown improved glycemic control in both a Zucker rat model of Type 2 Diabetes Mellitus (T2DM) and an alloxan-treated swine model of T2DM. To date, our team has successfully completed the pre-clinical development of the device, employing bioelectronics to optimize insulin production and manage blood glucose levels in a personalized manner, with the potential to treat Type 2 diabetes and hypoglycemia.'
About The ReShape Diabetes Neuromodulation Device
The ReShape Diabetes Neuromodulation system (formerly, Diabetes Bloc-Stim Neuromodulation™ (DBSN™) is a novel minimally invasive therapeutic implant concept that delivers bio-electronic neuromodulation of vagus nerve branches that are innervating organs which regulate plasma glucose. The system stimulates vagus celiac fibers of the pancreas to release insulin during stimulation, while blocking the hepatic vagal branch, innervating the liver, to decrease glucose release and decrease insulin resistance following ligation. The system utilizes a proprietary, reversable and adjustable electrical blockade that may represent the future of personalized medicine. Reshape Lifesciences believes its system is superior to both standalone stimulation of the vagus nerve, and vagus nerve ligation which has undesirable side effects and causes irreversible damage to the nerve.
About ReShape Lifesciences®
ReShape Lifesciences® is America's premier weight loss and metabolic health-solutions company, offering an integrated portfolio of proven products and services that manage and treat obesity and metabolic disease. The FDA-approved Lap-Band® and Lap-Band® 2.0 Flex Systems provide minimally invasive, long-term treatment of obesity and are an alternative to more invasive surgical stapling procedures such as the gastric bypass or sleeve gastrectomy. The Obalon® balloon technology is a non-surgical, swallowable, gas-filled intra-gastric balloon that is designed to provide long-lasting weight loss. For more information, please visit www.reshapelifesciences.com.
As previously announced ReShape has entered into an asset purchase agreement with Biorad Medisys, Pvt. Ltd., pursuant to which ReShape has agreed to sell substantially all of its assets to Biorad (or an affiliate thereof), including ReShape's Lap-Band® System, Obalon® Gastric Balloon System and the DBSN™ system (but excluding cash). Therefore, at the closing of the transactions contemplated by the asset purchase agreement, the DBSN™ system will be owned by Biorad.
Forward-Looking Safe Harbor Statement
This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results could differ materially from those discussed due to known and unknown risks, uncertainties, and other factors. These forward-looking statements generally can be identified by the use of words such as 'expect,' 'plan,' 'anticipate,' 'could,' 'may,' 'intend,' 'will,' 'continue,' 'future,' other words of similar meaning and the use of future dates. Forward-looking statements in this press release include statements about the promise of the Diabetes Neuromodulation technology and the potential path to commercialization of the technology. These and additional risks and uncertainties are described more fully in the company's filings with the Securities and Exchange Commission, including those factors identified as 'risk factors' in our most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q. We are providing this information as of the date of this press release and do not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise, except as required by law.
CONTACTS
Paul F. Hickey
949-276-7223
[email protected]
Investor Relations Contact:
Rx Communications Group
Michael Miller
917-633-6086
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
22 minutes ago
- Yahoo
Neurogene Reports Second Quarter 2025 Financial Results and Highlights Recent Updates
Announced design of Embolden™ registrational clinical trial of NGN-401 gene therapy for Rett syndrome; trial initiation activities underway Completed dosing in Phase 1/2 NGN-401 trial, and remains on track to report updated clinical efficacy and safety data in the second half of 2025 Cash runway into early 2028 NEW YORK, August 11, 2025--(BUSINESS WIRE)--Neurogene Inc. (Nasdaq: NGNE), a clinical-stage company founded to bring life-changing genetic medicines to patients and families affected by rare neurological diseases, today announced second quarter 2025 financial results and highlighted recent corporate updates. "In the first half of 2025, we made significant progress in our NGN-401 program for Rett syndrome. We completed dosing of the last five participants in the Phase 1/2 trial and received written agreement from the U.S. FDA on the key elements of the Embolden™ registrational trial, in which we have already begun initiation activities," stated Rachel McMinn, Ph.D., Founder and Chief Executive Officer of Neurogene. "We are pleased to be moving forward with Embolden, which was purposefully and rigorously designed to differentiate NGN-401 by evaluating participants as young as three years of age with a primary endpoint that incorporates measures that KOLs, caregivers and payors believe to be clinically meaningful. Our previously announced reallocation of capital provides us runway into early 2028, enabling us to focus our resources on advancement of this potential therapy for the patients and families who urgently need new treatment options." Dr. McMinn continued, "In leveraging the continual dialogue under the START program, the FDA encouraged the analysis of the Embolden primary endpoint to remain at 12 months as the basis for full approval, noting that a 6-month endpoint may not be considered clinically meaningful. In further maintaining the rigorous design of the Embolden trial, we are electing to dose the last planned participant from the Phase 1/2 trial as part of the registrational Embolden trial and add one more participant to complete the proposed sample size at 20 patients." Second Quarter 2025 and Recent Highlights, and Anticipated Milestones NGN-401 Gene Therapy for Treatment of Rett Syndrome Received written agreement from the U.S. Food and Drug Administration (FDA) on key elements of the Embolden registrational trial of NGN-401 and refined the sample size to propose 20 participants Initiated Embolden clinical trial activities to support the conversion of the Phase 1/2 trial to a registrational trial Completed enrollment in the Phase 1/2 trial, with the last 5 additional participants dosed in the first half of 2025 Remains on track to report updated clinical efficacy and safety data from the Phase 1/2 trial in the second half of 2025 Presented at scientific conferences the hemophagocytic lymphohistiocytosis (HLH) monitoring and treatment algorithm incorporated into the NGN-401 clinical trial, which has been acknowledged as valuable information by the Rett syndrome and gene therapy communities There has been no evidence of HLH/hyperinflammatory syndrome in any NGN-401 trial participant at the 1E15 vg dose level, as of the date of this press release Upcoming Events Stifel Biotech Summer Summit: Management will participate in a fireside chat at 12:00 p.m. ET on August 12 (not webcast) H.C. Wainwright Annual Global Investment Conference: Management will participate in a fireside chat at 2:30 p.m. ET on September 8 and participate in 1x1 meetings Second Quarter 2025 Financial Results Cash, Cash Equivalents and Short-Term Investments: Cash, cash equivalents and short-term investments as of June 30, 2025 were $274.5 million. We currently expect cash, cash equivalents and short-term investments to fund planned operations into early 2028. Research & Development (R&D) Expenses: R&D expenses were $19.4 million for the three months June 30, 2025 compared to $15.7 million for the three months ended June 30, 2024. The increase in R&D expenses for the three months ended June 30, 2025 was primarily driven by an increase in Rett syndrome clinical trial costs and employee-related expenses due to an increase in R&D headcount. General & Administrative (G&A) Expenses: G&A expenses were $6.7 million for the three months ended June 30, 2025 compared to $5.3 million for the three months ended June 30, 2024. The increase in G&A expenses for the three months ended June 30, 2025 was primarily driven by an increase in employee-related expenses due to an increase in stock-based compensation, headcount and other corporate expenses. Net Loss: Net loss was $22.0 million for the three months ended June 30, 2025 compared to $18.5 million for the three months ended June 30, 2024. About Neurogene The mission of Neurogene is to treat devastating neurological diseases to improve the lives of patients and families impacted by these rare diseases. Neurogene is developing novel approaches and treatments to address the limitations of conventional gene therapy in central nervous system disorders. This includes selecting a delivery approach to maximize distribution to target tissues and designing products to maximize potency and purity for an optimized efficacy and safety profile. The Company's novel and proprietary EXACT™ transgene regulation platform technology allows for the delivery of therapeutic levels while limiting transgene toxicity associated with conventional gene therapy. Neurogene has constructed a state-of-the-art gene therapy manufacturing facility in Houston, Texas. CGMP production of NGN-401 was conducted in this facility and will support pivotal clinical development activities. For more information, visit About NGN-401 NGN-401 is an investigational AAV9 gene therapy being developed as a one-time treatment for Rett syndrome. It is the first clinical candidate to deliver the full-length human MECP2 gene under the control of Neurogene's EXACT™ transgene regulation technology. EXACT technology is an important advancement in gene therapy for Rett syndrome, specifically because the disorder requires a treatment approach that enables targeted levels of MECP2 transgene expression without causing overexpression-related toxic effects associated with conventional gene therapy. NGN-401 was selected by the U.S. Food and Drug Administration (FDA) for its START Pilot Program and has also received Regenerative Medicine Advance Therapy (RMAT) designation, orphan drug designation, Fast Track designation and rare pediatric designation from the FDA. Neurogene was previously granted an INTERACT meeting with the FDA regarding the EXACT technology. NGN-401 also received Priority Medicines (PRIME) designation, orphan designation and advanced therapy medicinal product designation from the European Medicines Agency (EMA) and the Innovative Licensing and Application Pathway (ILAP) designation from the United Kingdom (UK) Medicines and Healthcare products Regulatory Agency (MHRA). Cautionary Note Regarding Forward-Looking Statements Statements in this press release are made as of the date of this press release. Neurogene does not undertake any obligation to make any updates to these statements to reflect events that occur or circumstances that arise after the date of this press release, except as may be required under applicable U.S. securities law. Statements in this press release which are not historical in nature are intended to be, and hereby are identified as, forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current expectations and beliefs of the management of Neurogene, as well as assumptions made by, and information currently available to, management of Neurogene, including, but not limited to, statements regarding: the therapeutic potential and utility, efficacy and clinical benefits of NGN-401; trial designs, clinical development plans and timing for NGN-401, including elements of the registrational clinical study trial design subject to final approval of the FDA, such as the proposed number of participants in the Embolden trial, and the timing of the conversion of the NGN-401 Phase 1/2 clinical trial to a registrational clinical trial, anticipated timing of additional updates for the Embolden registrational trial of NGN-401 for Rett syndrome; expected timing for additional interim data from the Company's NGN-401 Phase 1/2 trial for Rett Syndrome, expected future interactions with or positions of the FDA; and the time period over which existing cash resources may be sufficient to fund the Company's operations. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "anticipate," "plan," "likely," "believe," "estimate," "project," "intend," "on track," and other similar expressions or the negative or plural of these words, or other similar expressions that are predictions or indicate future events or prospects, although not all forward-looking statements contain these words. Forward-looking statements are based on current beliefs and assumptions that are subject to risks, uncertainties and assumptions that are difficult to predict with regard to timing, extent, likelihood, and degree of occurrence, which could cause actual results to differ materially from anticipated results and many of which are outside of Neurogene's control. Such risks, uncertainties and assumptions include, among other things: the expected timing of additional results from the NGN-401 clinical trial; the potential for negative impacts to participants in the Phase 1/2 clinical trial of NGN-401 for the treatment of Rett syndrome; the risk that the Company may not be able to report data on the predicted timeline; risks related to the Company's ability to obtain regulatory approval for, and ultimately commercialize, its product candidates, including NGN-401; risks related to timing of initiating the Embolden trial of NGN-401 for Rett syndrome; and other risks and uncertainties identified under the heading "Risk Factors" included in Neurogene's Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, filed with the Securities and Exchange Commission ("SEC") on August 11, 2025, and other filings that the Company has made and may make with the SEC in the future. Nothing in this communication should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that the contemplated results of any such forward-looking statements will be achieved. Forward-looking statements in this communication speak only as of the day they are made and are qualified in their entirety by reference to the cautionary statements herein. Except as required by applicable law, Neurogene 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. This communication contains hyperlinks to information that is not deemed to be incorporated by reference into this communication. - Financial Tables Follow - Neurogene Inc. Condensed Consolidated Balance Sheet Data (In thousands of U.S. dollars) June 30,2025 December 31,2024 Assets Cash and cash equivalents $ 58,813 $ 136,586 Short-term investments 215,706 175,819 Other current assets 4,467 3,518 Non-current assets 18,330 19,807 Total assets $ 297,316 $ 335,730 Liabilities Current liabilities 15,440 15,157 Non-current liabilities 8,621 10,198 Total liabilities 24,061 25,355 Stockholders' equity 273,255 310,375 Total liabilities and stockholders' equity $ 297,316 $ 335,730 Neurogene Inc. Condensed Consolidated Statements of Operations (In thousands of U.S. dollars, except share information) Three Months EndedJune 30, Six Months EndedJune 30, 2025 2024 2025 2024 Revenue under licensing agreements — 925 — 925 Operating expenses: Research and development expenses 19,366 15,744 37,131 29,285 General and administrative expenses 6,715 5,315 14,869 10,553 Total operating expenses 26,081 21,059 52,000 39,838 Loss from operations (26,081 ) (20,134 ) (52,000 ) (38,913 ) Other income, net 4,065 1,642 7,337 3,500 Net loss $ (22,016 ) $ (18,492 ) $ (44,663 ) $ (35,413 ) Per share information: Net loss per share, basic and diluted $ (1.05 ) $ (1.09 ) $ (2.12 ) $ (2.09 ) Weighted-average shares of common stock outstanding, basic and diluted 21,055,378 16,941,524 21,025,996 16,922,630 View source version on Contacts Company Contact: Cara MayfieldVice President, Corporate Investor Contact: Melissa ForstArgot PartnersNeurogene@ Sign in to access your portfolio
Business Wire
an hour ago
- Business Wire
Summit Therapeutics Reports Financial Results and Operational Progress for the Second Quarter Ended June 30, 2025
MIAMI--(BUSINESS WIRE)--Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") today reports its financial results and provides an update on operational progress for the second quarter ended June 30, 2025. Operational & Corporate Updates Operational progress continues with ivonescimab (SMT112), an investigational, potentially first-in-class bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule: Since in-licensing ivonescimab (SMT112), from Akeso Inc. (Akeso, HKEX Code: in January 2023, over 2,800 patients have been treated in clinical studies globally. Summit has rights to develop and commercialize ivonescimab in the United States, Canada, Europe, Japan, Latin America, including Mexico and all countries in Central America, South America, and the Caribbean, the Middle East, and Africa while Akeso retains development and commercialization rights for the rest of the world, including China. Summit is developing ivonescimab in non-small cell lung cancer ('NSCLC'), specifically conducting Phase III clinical trials in the following proposed indications: HARMONi: Ivonescimab combined with chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI) HARMONi-3: Ivonescimab combined with chemotherapy in first-line patients with metastatic NSCLC HARMONi - 7: Ivonescimab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression In May 2025, we announced topline results from our multiregional, double-blinded, placebo-controlled, Phase III study, HARMONi. At the prespecified primary data analysis, ivonescimab in combination with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS), with a hazard ratio of 0.52 (95% CI: 0.41 – 0.66; p<0.00001). PFS was measured by blinded independent central radiology review committee (BICR) compared to placebo in combination with chemotherapy. A clinically meaningful hazard ratio was observed in both Asia and ex-Asia sub-populations. The primary analysis demonstrated the consistency of the magnitude of the PFS benefit between patients randomized in Asia and ex-Asia, as well as the consistency in a single-region study (HARMONi-A) with this multiregional study. Ivonescimab in combination with chemotherapy showed a positive trend in overall survival (OS) in the primary analysis without achieving a statistically significant benefit with a hazard ratio of 0.79 (95% CI: 0.62 – 1.01; p=0.057). This trend provides further support for its use in 2L+ EGFRm NSCLC, a setting where high unmet need continues to exist with limited approved options in the United States and other western territories. Currently there are no FDA-approved regimens that have demonstrated a statistically significant OS benefit in this patient setting. The median follow-up time for western patients was less than the median OS at the time of the analysis, and these patients may continue to be followed for long-term outcomes. Both Asian and North American patients demonstrated a positive trend in OS. The results of the primary analysis in this multiregional study were consistent with that of the single-region HARMONi-A study, which demonstrated an OS hazard ratio of 0.80 at 52% data maturity in a similar patient population. The safety profile of ivonescimab in combination with chemotherapy was acceptable and manageable in the context of the observed clinical benefit. Based on the results of the HARMONi clinical trial, Summit, at present time, intends to file a Biologics License Application (BLA) in order to seek approval for ivonescimab plus chemotherapy in this setting. Based on discussions with the United States Food & Drug Administration (FDA), under our determination and subject to our review, Summit will consider the timing of the filing of this BLA. A more complete data presentation from HARMONi is intended to be shared at a future major medical conference. In April 2025, Akeso announced that HARMONi-6 met its primary endpoint of PFS. This trial, conducted in China by our partners at Akeso with all relevant data exclusively generated, managed, and analyzed by Akeso, evaluated ivonescimab combined with platinum-based chemotherapy against tislelizumab, a PD-1 inhibitor, with the same chemotherapy in patients with locally advanced or metastatic squamous NSCLC, regardless of PD-L1 expression. HARMONi-6 showed statistically significant and clinically meaningful improvement in PFS for ivonescimab plus chemotherapy, and no new safety signals were identified. This marks the first known Phase III trial in NSCLC to show significant improvement over PD-(L)1 inhibitor therapy combined with chemotherapy in a head-to-head setting. Following the success of Akeso's HARMONi-2 study in China, this is the second instance where ivonescimab-based regimens have demonstrated a statistically significant benefit compared to standard-of-care PD-(L)1 inhibitor-based regimens in a Phase III. The full data set for HARMONi-6 is planned to be presented at an upcoming major medical conference. Also in April 2025, Akeso announced that ivonescimab was approved by the Chinese Health Authorities, the National Medical Products Administration (NMPA), for a second indication based on the results of the Phase III clinical trial, HARMONi-2. HARMONi-2 evaluated monotherapy ivonescimab against monotherapy pembrolizumab in patients with locally advanced or metastatic NSCLC whose tumors have positive PD-L1 expression. In conjunction with the approval announcement, Akeso announced that the results of a NMPA-requested interim OS analysis included a hazard ratio of 0.777. The analysis was conducted at 39% data maturity, with a nominal alpha level of 0.0001. HARMONi-2 is a single region, multi-center, Phase III study conducted in China sponsored by Akeso with all relevant data exclusively generated, managed, and analyzed by Akeso. Clinical trial collaborations and investigator sponsored trials with leading organizations, including MD Anderson, the Memorial Sloan Kettering Cancer Center, and the Dana Farber Cancer Institute, among others, continue to progress and expand evaluating ivonescimab in solid tumor settings outside of metastatic NSCLC. In June 2025, we announced a clinical collaboration with Revolution Medicines to evaluate ivonescimab in combination with three RAS(ON) inhibitors, including the multi-selective inhibitor daraxonrasib (RMC-6236), G12D-selective inhibitor zoldonrasib (RMC-9805), and G12C-selective inhibitor elironrasib (RMC-6291), in solid tumor settings with RAS mutations. Enrollment continues in Summit's global Phase III trials, HARMONi-3 and HARMONi-7. In addition to the enrollment in multiregional studies conducted and sponsored by Summit, our partners at Akeso are also enrolling several single-region Phase III studies exclusively in China in multiple indications, including biliary-tract cancer, triple-negative breast cancer, head and neck squamous cell carcinoma, microsatellite stable colorectal cancer, and pancreatic cancer. Financial Highlights Cash and Cash Equivalents and Short-term Investments Aggregate cash and cash equivalents and short-term investments were $297.9 million and $412.3 million at June 30, 2025 and December 31, 2024, respectively. On August 11, 2025, the Company amended its Distribution Agreement with J.P. Morgan Securities LLC, (the 'Sales Agent'), pursuant to which the Company may offer and sell, in an at-the-market (ATM) offering, from time to time, through the Sales Agent, additional shares of the Company's common stock, having an aggregate offering price of up to $360.0 million. The Company filed a prospectus supplement with the SEC on August 11, 2025 in connection with this offer and sale of the shares pursuant to the Distribution Agreement. The Company has no obligation to sell any of the shares under the Distribution Agreement and may at any time suspend solicitations and offers under the Distribution Agreement. Stock-Based Compensation Modification Expense On April 29, 2025, the compensation committee of the board of directors approved a modification to the Company's outstanding unvested performance-based stock option awards for certain employees and executives in order to require only service-based vesting requirements to continue vesting considering the overall performance of the company including achievement of the performance goals related to market capitalization of the company for a sustained period of time. As a result, certain options immediately vested on the date of modification, and the remaining options continue to vest over a designated period of time. On the modification date, 44.5 million options were valued. These 44.5 million options which were modified represent approximately 6% of total shares outstanding as of June 30, 2025. There had been no prior expense recognized for these unvested performance-based stock options. Based on generally accepted accounting principles in the U.S. (US GAAP), total non-cash stock-based compensation expense for this modification was calculated based on the closing share price of $23.62 on the date of modification. Non-cash stock-based compensation expense for the stock options which were immediately vested on the modification date was calculated based on their intrinsic value. For the options which will continue to vest over the future service period, non-cash stock-based compensation expense was calculated using the Black-Scholes valuation methodology. For this modification, total non-cash stock-based compensation expense of $466.6 million was recognized during the three months ended June 30, 2025. The unrecognized non-cash stock-based compensation expense of $454.6 million will be recognized over the future remaining service period. GAAP and Non-GAAP Operating Expenses GAAP operating expenses were $568.4 million for the second quarter of 2025, compared to $59.6 million for the same period of the prior year. The increase in GAAP operating expenses was primarily due to the increase in stock-based compensation expense of approximately $466.6 million as a result of the stock option modification noted above. Non-GAAP operating expenses were $89.6 million for the second quarter of 2025, compared to $48.5 million for the same period of the prior year. The increase in Non-GAAP operating expenses due to expansion of clinical studies and development costs related to ivonescimab. GAAP and Non-GAAP Research and Development (R&D) Expenses GAAP R&D expenses were $208.0 million for the second quarter of 2025, compared to $30.8 million for the same period of the prior year. This increase was primarily due to the increase in stock-based compensation expense of approximately $123.7 million as a result of the stock option modification noted above. Non-GAAP R&D expenses were $79.4 million for the second quarter of 2025, compared to $27.3 million for the same period of the prior year. The increase is primarily related due to expansion of clinical studies and development costs related to ivonescimab. GAAP and Non-GAAP General and Administrative (G&A) Expenses GAAP G&A expenses were $360.4 million for the second quarter of 2025, compared to $13.8 million for the same period of the prior year. The increase was primarily due to the increase in stock-based compensation expense of approximately $342.9 million as a result of the stock option modification noted above. Non-GAAP G&A expenses were $10.2 million for the second quarter of 2025, compared to $6.2 million for the same period of the prior year. The increase is related to building our infrastructure to support development of ivonescimab. GAAP and Non-GAAP Net Loss GAAP net loss in the second quarter of 2025 and 2024 was $565.7 million or $(0.76) per basic and diluted share, and $60.4 million or $(0.09) per basic and diluted share, respectively. Non-GAAP net loss in the second quarter of 2025 and 2024 was $86.9 million or $(0.12) per basic and diluted share, and $49.3 million or $(0.07) per basic and diluted share, respectively. Use of Non-GAAP Financial Measures This release includes measures that are not in accordance with U.S. generally accepted accounting principles ('Non-GAAP measures'). These Non-GAAP measures should be viewed in addition to, and not as a substitute for, Summit's reported GAAP results, and may be different from Non-GAAP measures used by other companies. In addition, these Non-GAAP measures are not based on any comprehensive set of accounting rules or principles. Summit management uses these non-GAAP measures for internal budgeting and forecasting purposes and to evaluate Summit's financial performance. Summit management believes the presentation of these Non-GAAP measures is useful to investors for comparing prior periods and analyzing ongoing business trends and operating results. For further information regarding these Non-GAAP measures, please refer to the tables presenting reconciliations of our Non-GAAP results to our U.S. GAAP results and the 'Notes on our Non-GAAP Financial Information' that accompany this press release. About Ivonescimab Ivonescimab, known as SMT112 in Summit's license territories, North America, South America, Europe, the Middle East, Africa, and Japan, and as AK112 in China and Australia, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity to PD-1 when in the presence of VEGF. This could differentiate ivonescimab as there is potentially higher expression (presence) of both PD-1 and VEGF in tumor tissue and the tumor microenvironment (TME) as compared to normal tissue in the body. Ivonescimab's tetravalent structure (four binding sites) enables higher avidity (accumulated strength of multiple binding interactions) in the TME (Zhong, et al, SITC, 2023). This tetravalent structure, the intentional novel design of the molecule, and bringing these two targets into a single bispecific antibody with cooperative binding qualities have the potential to direct ivonescimab to the tumor tissue versus healthy tissue. The intent of this design, together with a half-life of 6 to 7 days after the first dose (Zhong, et al, SITC, 2023), is to improve upon previously established efficacy thresholds, in addition to side effects and safety profiles associated with these targets. Ivonescimab was engineered by Akeso Inc. (HKEX Code: and is currently engaged in multiple Phase III clinical trials. Over 2,800 patients have been treated with ivonescimab in clinical studies globally. Summit began its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), commencing enrollment in 2023 in two multiregional Phase III clinical trials, HARMONi and HARMONi-3. Additionally, in early 2025 the Company began enrolling clinical trial sites in the United States for HARMONi-7. HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g., osimertinib). Enrollment in HARMONi was completed in the second half of 2024, and top-line results were announced in May of 2025. HARMONi-3 is a Phase III clinical trial which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic, squamous or non-squamous NSCLC, irrespective of PD-L1 expression. HARMONi-7 is a Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression. In addition, Akeso has recently had positive read-outs in three single-region (China), randomized Phase III clinical trials for ivonescimab in NSCLC: HARMONi-A, HARMONi-2, and HARMONi-6. HARMONi-A was a Phase III clinical trial which evaluated ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with an EGFR TKI. HARMONi-2 is a Phase III clinical trial evaluating monotherapy ivonescimab against monotherapy pembrolizumab in patients with locally advanced or metastatic NSCLC whose tumors have positive PD-L1 expression. HARMONi-6 is a Phase III clinical trial evaluating ivonescimab in combination with platinum-based chemotherapy compared with tislelizumab, an anti-PD-1 antibody, in combination with platinum-based chemotherapy in patients with locally advanced or metastatic squamous NSCLC, irrespective of PD-L1 expression. Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit's license territories, including the United States and Europe. Ivonescimab was initially approved for marketing authorization in China in May 2024. Ivonescimab was granted Fast Track designation by the US Food & Drug Administration (FDA) for the HARMONi clinical trial setting. About Summit Therapeutics Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on the discovery, development, and commercialization of patient-, physician-, caregiver- and societal-friendly medicinal therapies intended to improve quality of life, increase potential duration of life, and resolve serious unmet medical needs. Summit was founded in 2003 and our shares are listed on the Nasdaq Global Market (symbol "SMMT"). We are headquartered in Miami, Florida, and we have additional offices in Menlo Park, California, and Oxford, UK. For more information, please visit and follow us on X @SMMT_TX. Summit Forward-looking Statements Any statements in this press release about the Company's future expectations, plans and prospects, including but not limited to, statements about the clinical and preclinical development of the Company's product candidates, entry into and actions related to the Company's partnership with Akeso Inc., the Company's anticipated spending and cash runway, the therapeutic potential of the Company's product candidates, the potential commercialization of the Company's product candidates, the timing of initiation, completion and availability of data from clinical trials, the potential submission of applications for marketing approvals, potential acquisitions, statements about the previously disclosed At-The-Market equity offering program ('ATM Program'), the expected proceeds and uses thereof, the Company's estimates regarding stock-based compensation, and other statements containing the words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "would," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the Company's ability to sell shares of our common stock under the ATM Program, the conditions affecting the capital markets, general economic, industry, or political conditions, the results of our evaluation of the underlying data in connection with the development and commercialization activities for ivonescimab, the outcome of discussions with regulatory authorities, including the Food and Drug Administration, the uncertainties inherent in the initiation of future clinical trials, availability and timing of data from ongoing and future clinical trials, the results of such trials, and their success, global public health crises, that may affect timing and status of our clinical trials and operations, whether preliminary results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials or preclinical studies will be indicative of the results of later clinical trials, whether business development opportunities to expand the Company's pipeline of drug candidates, including without limitation, through potential acquisitions of, and/or collaborations with, other entities occur, expectations for regulatory approvals, laws and regulations affecting government contracts and funding awards, availability of funding sufficient for the Company's foreseeable and unforeseeable operating expenses and capital expenditure requirements and other factors discussed in the "Risk Factors" and 'Management's Discussion and Analysis of Financial Condition and Results of Operations' sections of filings that the Company makes with the Securities and Exchange Commission. Any change to our ongoing trials could cause delays, affect our future expenses, and add uncertainty to our commercialization efforts, as well as to affect the likelihood of the successful completion of clinical development of ivonescimab. Accordingly, readers should not place undue reliance on forward-looking statements or information. In addition, any forward-looking statements included in this press release represent the Company's views only as of the date of this release and should not be relied upon as representing the Company's views as of any subsequent date. The Company specifically disclaims any obligation to update any forward-looking statements included in this press release. Summit Therapeutics and the Summit Therapeutics logo are trademarks of Summit Therapeutics Inc. Copyright 2025, Summit Therapeutics Inc. All Rights Reserved Summit Therapeutics Inc. GAAP Condensed Consolidated Balance Sheet Information (in millions) Unaudited December 31, 2024 Cash and cash equivalents and short-term investments $ 297.9 $ 412.3 Total assets $ 324.0 $ 435.6 Total liabilities $ 64.6 $ 46.8 Total stockholders' equity $ 259.4 $ 388.7 Expand Summit Therapeutics Inc. GAAP Condensed Consolidated Statement of Cash Flows Information (in millions) Unaudited Six Months Ended June 30, 2025 2024 Net cash used in operating activities $ (127.9 ) $ (63.1 ) Net cash provided by (used in) investing activities 310.9 (180.2 ) Net cash provided by financing activities 9.9 200.7 Effect of exchange rates on cash and cash equivalents 0.1 — Increase (decrease) in cash, cash equivalents and restricted cash $ 193.0 $ (42.6 ) Expand Summit Therapeutics Inc. Schedule Reconciling Selected Non-GAAP Financial Measures (Unaudited) (in millions, except per share data) Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024 Reconciliation of GAAP to Non-GAAP Research and Development Expense GAAP Research and development $ 208.0 $ 30.8 $ 259.3 $ 61.7 Stock-based compensation (Note 1) (128.6 ) (3.5 ) (132.7 ) (5.9 ) Non-GAAP Research and development $ 79.4 $ 27.3 $ 126.6 $ 55.8 Reconciliation of GAAP to Non-GAAP General and Administrative Expenses GAAP General and administrative $ 360.4 $ 13.8 $ 376.0 $ 25.3 Stock-based compensation (Note 1) (350.2 ) (7.6 ) (357.2 ) (14.7 ) Non-GAAP General and administrative $ 10.2 $ 6.2 $ 18.8 $ 10.6 Reconciliation of GAAP to Non-GAAP Operating Expenses GAAP Operating expenses $ 568.4 $ 59.6 $ 635.3 $ 102.0 Stock-based compensation (Note 1) (478.8 ) (11.1 ) (489.9 ) (20.6 ) Non-GAAP Operating expense $ 89.6 $ 48.5 $ 145.4 $ 81.4 Reconciliation of GAAP Net Loss to Non-GAAP Net Loss GAAP Net Loss $ (565.7 ) $ (60.4 ) $ (628.6 ) $ (103.9 ) Stock-based compensation (Note 1) 478.8 11.1 489.9 20.6 Non-GAAP Net Loss $ (86.9 ) $ (49.3 ) $ (138.7 ) $ (83.3 ) Reconciliation of GAAP Net Loss to Non-GAAP Net Loss Per Common Share GAAP Net Loss Per Basic and Diluted Common Share $ (0.76 ) $ (0.09 ) $ (0.85 ) $ (0.15 ) Stock-based compensation (Note 1) 0.64 0.02 0.66 0.03 Non-GAAP Net loss Per Basic and Diluted Common Share $ (0.12 ) $ (0.07 ) $ (0.19 ) $ (0.12 ) Basic and Diluted Common Shares 742.6 707.9 740.4 704.8 Expand Summit Therapeutics Inc. Schedule Reconciling Selected Non-GAAP Financial Measures (in millions) Unaudited June 30, 2025 March 31, 2025 December 31, 2024 September 30, 2024 June 30, 2024 Reconciliation of GAAP to Non-GAAP Operating Expenses GAAP Operating expenses $ 568.4 $ 66.8 $ 65.6 $ 58.4 $ 59.6 Stock-based compensation (Note 1) (478.8 ) (11.1 ) (11.0 ) (19.4 ) (11.1 ) Non-GAAP Operating Expense (Note 2) $ 89.6 $ 55.7 $ 54.6 $ 39.0 $ 48.5 Reconciliation of GAAP Net Loss to Non-GAAP Net Loss GAAP Net Loss $ (565.7 ) $ (62.9 ) $ (61.2 ) $ (56.3 ) $ (60.4 ) Stock-based compensation (Note 1) 478.8 11.1 11.0 19.4 11.1 Non-GAAP Net Loss (Note 2) $ (86.9 ) $ (51.8 ) $ (50.2 ) $ (36.9 ) $ (49.3 ) Expand Summit Therapeutics Inc. Notes on our Non-GAAP Financial Information Non-GAAP financial measures adjust GAAP financial measures for the items listed below. These Non-GAAP measures should be viewed in addition to, and not as a substitute for Summit's reported GAAP results, and may be different from Non-GAAP measures used by other companies. In addition, these Non-GAAP measures are not based on any comprehensive set of accounting rules or principles. Summit management uses these non-GAAP measures for internal budgeting and forecasting purposes and to evaluate Summit's financial performance. Summit management believes the presentation of these Non-GAAP measures is useful to investors for comparing prior periods and analyzing ongoing business trends and operating results. Each of non-GAAP Research and Development Expense, non-GAAP General and Administrative Expenses, non-GAAP Operating Expenses, Non-GAAP Net Loss and Non-GAAP EPS differ from GAAP in that such measures exclude the non-cash charges and costs associated with stock-based compensation. Note 1: Stock-based compensation is a non-cash charge and costs calculated for this expense can vary year-over-year depending on the stock price of awards on the date of grant as well as the timing of compensation award arrangements. Note 2: Beginning in the fourth quarter of 2024, the Company's non-GAAP financial measures will no longer exclude acquired in-process research and development expenses ('IPR&D'). Non-GAAP financial measures for the three months ended June 30, 2024 previously excluded $15.0 million of IPR&D which represented an upfront payment made to Akeso under an amendment to the Collaboration and License Agreement. Prior period amounts have been revised to conform to the current period presentation. Appendix: Glossary of Critical Terms Contained Herein Affinity – Affinity is the strength of binding of a molecule, such as a protein or antibody, to another molecule, such as a ligand. Avidity – Avidity is the accumulated strength of multiple binding interactions. Angiogenesis – Angiogenesis is the development, formation, and maintenance of blood vessel structures. Without sufficient blood flow, tissue may experience hypoxia (insufficient oxygen) or lack of nutrition, which may cause cell death. 1 Cooperative binding – Cooperative binding occurs when the number of binding sites on the molecule that can be occupied by a specific ligand (e.g., protein) is impacted by the ligand's concentration. For example, this can be due to an affinity for the ligand that depends on the amount of ligand bound or the binding strength of the molecule to one ligand based on the concentration of another ligand, increasing the chance of another ligand binding to the compound. 2 Immunotherapy – Immunotherapy is a type of treatment, including cancer treatments, that help a person's immune system fight cancer. Examples include anti-PD-1 therapies. 3 Intracranial - Within the cranium or skull. PD-1 – Programmed cell Death protein 1 is a protein on the surface of T cells and other cells. PD-1 plays a key role in reducing the regulation of ineffective or harmful immune responses and maintaining immune tolerance. However, with respect to cancer tumor cells, PD-1 can act as a stopping mechanism (a brake or checkpoint) by binding to PD-L1 ligands that exist on tumor cells and preventing the T cells from targeting cancerous tumor cells. 4 PD-L1 – Programmed cell Death Ligand 1 is expressed by cancerous tumor cells as an adaptive immune mechanism to escape anti-tumor responses, thus believed to suppress the immune system's response to the presence of cancer cells. 5 PD-L1 TPS – PD-L1 Tumor Proportion Score represents the percentage of tumor cells that express PD-L1 proteins. PFS – Progression-Free Survival. RANO – Response Assessment in Neuro-Oncology, the standard for assessing the response of a brain or spinal cord tumor to therapy. SQ-NSCLC – Non-small cell lung cancer tumors of squamous histology. T Cells – T cells are a type of white blood cell that is a component of the immune system that, in general, fights against infection and harmful cells like tumor cells. 6 Tetravalent – A tetravalent molecule has four binding sites or regions. Tumor Microenvironment – The tumor microenvironment is the ecosystem that surrounds a tumor inside the body. It includes immune cells, the extracellular matrix, blood vessels and other cells, like fibroblasts. A tumor and its microenvironment constantly interact and influence each other, either positively or negatively. 7 VEGF – Vascular Endothelial Growth Factor is a signaling protein that promotes angiogenesis. 8 __________________ 1 Shibuya M. Vascular Endothelial Growth Factor (VEGF) and Its Receptor (VEGFR) Signaling in Angiogenesis: A Crucial Target for Anti- and Pro-Angiogenic Therapies. Genes Cancer. 2011 Dec;2(12):1097-105 2 Stefan MI, Le Novère N. Cooperative binding. PLoS Comput Biol. 2013;9(6) 3 US National Cancer Institute, a part of the National Institute of Health (NIH). Accessed April 2024. 4 Han Y, et al. PD-1/PD-L1 Pathway: Current Researches in Cancer. Am J Cancer Res. 2020 Mar 1;10(3):727-742. 5 Han Y, et al. PD-1/PD-L1 Pathway: Current Researches in Cancer. Am J Cancer Res. 2020 Mar 1;10(3):727-742. 6 Cleveland Clinic. Accessed April 2024. 7 MD Anderson Cancer Center. Accessed April 2024. 8 Shibuya M. Vascular Endothelial Growth Factor (VEGF) and Its Receptor (VEGFR) Signaling in Angiogenesis: A Crucial Target for Anti- and Pro-Angiogenic Therapies. Genes Cancer. 2011 Dec;2(12):1097-105. Expand
Yahoo
an hour ago
- Yahoo
Nuvectis Pharma Announces the Initiation of the Phase 1b Program for NXP900
The Phase 1b program is designed to evaluate the clinical activity of NXP900 as a single agent in patients with advanced solid tumors whose cancers harbor specific genetic alterations, and in combination with EGFR and ALK inhibitors in patients with NSCLC whose cancers developed resistance to these treatments Nuvectis will hold a conference call tomorrow, Tuesday, August 12 at 8:30 AM ET to discuss the elements of the Phase 1b program and the overall market opportunity for NXP900 Fort Lee, NJ, Aug. 11, 2025 (GLOBE NEWSWIRE) -- Nuvectis Pharma, Inc. (NASDAQ: NVCT), a clinical stage biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology, today announced the initiation of the Phase 1b program for NXP900. NXP900 Phase 1b clinical program The Phase 1b program was initiated following the successful completion of a dose escalation study in patients with advanced solid tumors and a clinical drug-drug interaction study in healthy volunteer, and is intended to include a single agent component, which is now underway, and a combination component that is expected to commence later this year. Single agent: We will evaluate patients with specific genetic alterations selected based on their characteristics as either direct (YES1 amplification), or dependent (Hippo Pathway alterations) targets of NXP900, and the tumor types were selected based on the prevalence of the relevant genetic alterations and supporting scientific data. These include: YES1 amplified or FAT1 mutated non-small cell lung cancer (NSCLC) NF2 mutated mesothelioma and renal cancer Other advanced solid tumors with any of the genetic alterations mentioned above or other relevant Hippo Pathway alterations Combination: We plan to evaluate NXP900 in combination with market-leading epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) inhibitors for the treatment of non-small cell lung cancer, in patients who have initially responded to treatment and subsequently developed acquired resistance and experienced disease progression. Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis commented, "We are very excited to announce the initiation of the NXP900 Phase 1b program, starting with the single agent segment. We believe that NXP900 represents a unique 'pipeline in a pill' opportunity with the potential to address several substantial areas of unmet medical need in oncology. The Phase 1b protocol was designed to showcase the potential of NXP900 as an important treatment option for various types of cancer and increase the likelihood of observing a therapeutic effect, building on an extensive scientific program to understand the underlying biology of specific cancers that may confer sensitivity to treatment with NXP900. We have high expectations for the Phase 1b program for NXP900 based on a robust dataset comprised of early mechanistic studies, preclinical proof of concept results and the emerging clinical profile from the completed Phase 1a and drug-drug interaction clinical studies,' added Mr. Bentsur. 'Additionally, we believe that the recent acquisition of shares by a highly regarded healthcare-specialized institutional investor is a vote of confidence in this Phase 1b program, and that we are well funded to execute on our ambitious plans for NXP900.' Conference Call and Webcast Information Date: Tuesday, August 12, 2025, at 8:30 AM ET Participant Dial-in (U.S.): 1-877-407-0784 Participant Dial-in (International): 1-201-689-8560 Webcast Access: Click Here A replay of the webcast will be available on the Investors section of the Nuvectis website at About Nuvectis Pharma, Inc. Nuvectis Pharma, Inc. is a biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology. The Company's assets include two clinical-stage drug candidates, NXP900 and NXP800. NXP900 is an oral small molecule inhibitor of the SRC Family of Kinases (SFK), including SRC and YES1. Its unique mechanism of action enables inhibition of both the catalytic and scaffolding functions of the SRC kinase, providing comprehensive shutdown of the signaling pathway. NXP900 has completed a Phase 1a dose escalation study and the Phase 1b program has been initiated. NXP800 is an oral small molecule GCN2 activator that has demonstrated anti-cancer activity in recurrent, platinum-resistant, ARID1a-mutated ovarian cancer, and may be explored in the future in other cancer types. For additional information about Nuvectis Pharma please visit: Forward Looking Statements This press release contains "forward-looking statements" within the meaning of the U.S. federal securities laws, which are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate', "believe', "contemplate', "could', "estimate', "expect', "intend', "seek', "may', "might', "plan', "potential', "predict', "project', "target', "aim', "should', "will', "would', or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Nuvectis Pharma, Inc.'s current expectations and interpretations of data and information available, including preclinical and clinical safety, pharmacokinetics, pharmacodynamics, and efficacy data generated to date for NXP900 and the timing and data expectations for the NXP900 Phase 1b study and estimates and projections regarding our financial condition. The outcomes of the events described in these forward-looking statements are subject to inherent uncertainties, risks, assumptions, market and other conditions, and other factors that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties may also be subject to market and other conditions and described more fully in the section titled "Risk Factors" in our Q2 2025 Form 10-Q and our other public filings with the U.S. Securities and Exchange Commission ("SEC"). However, these risks are not exhaustive and new risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this press release or other filings with the SEC. Any forward-looking statements contained in this press release speak only as of the date of this press release. 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 may be required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Company ContactRon BentsurChairman, Chief Executive Officer and Presidentrbentsur@ Media Relations ContactKevin GardnerLifeSci Advisorskgardner@ Sign in to access your portfolio
