MK677 for Lean Muscle Gains: Does It Really Work?
MK-677, also known as Ibutamoren, is a growth hormone secretagogue. This means it helps the body produce more growth hormone. Growth hormone plays a big role in muscle growth, fat loss, and recovery. MK-677 is popular because it is taken orally, unlike other substances that require injections.
MK-677 works by increasing the levels of growth hormone (GH) and insulin-like growth factor 1 (IGF-1) in the body. These hormones are important for muscle growth and repair. Here's how MK-677 supports lean muscle gains: Boosts Growth Hormone Naturally
MK-677 tells the pituitary gland to release more growth hormone. This natural increase helps in muscle growth without the need for synthetic hormones.
Improves Muscle Recovery
Faster recovery means you can train harder and more often. MK-677 helps muscles repair after workouts, which is essential for building lean muscle over time.
Increases Muscle Fullness
Many users report that their muscles look fuller and feel denser after using MK-677. This effect is due to improved water retention in muscles, which also supports joint health.
Prevents Muscle Wasting
MK-677 is often studied for its role in preventing muscle wasting. It helps preserve muscle mass, especially during calorie deficits or cutting phases.
Unlike anabolic steroids, MK-677 does not directly bind to androgen receptors. This means it does not carry the same side effects like hair loss, acne, or liver toxicity. People prefer MK-677 because it boosts natural hormone levels without harsh side effects.
However, it's important to understand that MK-677 is not a magic pill. You still need a proper diet and exercise to see results. It works best as a support to your hard work in the gym.
Most users notice changes in muscle fullness and better sleep within the first 2 to 3 weeks. For noticeable muscle gains, it can take 8 to 12 weeks of consistent use. Results can vary depending on your workout routine, diet, and body type.
When it comes to research compounds, quality and purity are very important. This is why many people choose to buy MK-677 from PureRawz. Here are some reasons: Lab-Tested for Purity
PureRawz provides lab reports to prove the purity of their products. You know exactly what you are getting.
PureRawz provides lab reports to prove the purity of their products. You know exactly what you are getting. Trusted by Athletes and Researchers
PureRawz is a known name in the fitness and research community. Their products are used by those who are serious about quality.
PureRawz is a known name in the fitness and research community. Their products are used by those who are serious about quality. Easy and Safe Online Purchase
You can easily order MK-677 from PureRawz through their website. They ensure fast shipping and discreet packaging.
Like any supplement, MK-677 may have some side effects, especially if taken in high doses. Common side effects can include: Increased appetite
Mild water retention
Temporary numbness or tingling in hands and feet
Tiredness during the first week (as the body adjusts)
Most of these effects are mild and go away as your body gets used to MK-677.
For muscle building, a common dosage is between 20mg to 25mg per day. Some people start with 10mg to see how their body reacts. It is usually taken once a day, as MK-677 has a long half-life.
It's best to start with a lower dose and gradually increase it. Always listen to your body and consult a healthcare professional if unsure.
Yes, MK-677 can help improve lean muscle gains by boosting growth hormone levels naturally. It supports muscle growth, improves recovery, and helps maintain muscle mass. However, it is not a replacement for a proper workout routine and diet.
If you are planning to buy MK-677, make sure you choose a trusted source like PureRawz to ensure you get a high-quality product. With patience, hard work, and the right product, MK-677 can be a helpful tool in your muscle-building journey.
TIME BUSINESS NEWS
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Business Wire
5 hours 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
8 hours ago
- Yahoo
Lilly first to opt for confidential reimbursement price in Germany
Eli Lilly has announced that it will take up the option of a confidential discount in Germany for Mounjaro in Type 2 diabetes (T2D). The announcement has reignited controversies around the disputed policy, and the alleged link between its implementation and Lilly's large new investment in Germany, announced in 2024. Eli Lilly (US) has confirmed that it intends to take up the option of a confidential reimbursement price for its dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist Mounjaro (tirzepatide) in the treatment of T2D in Germany. This will be the first time the option has been taken up since it was introduced at the beginning of 2025, under the Medical Research Act (Medizinforschungsgesetz, MFG). Lilly's plan to opt for confidential pricing was first reported by German newspaper Süddeutsche Zeitung and the public broadcasters Norddeutscher Rundfunk and Westdeutsche Rundfunk, which referred to a communication from the company to physicians in Germany, explaining its plans and reportedly asserting that the price negotiated with the statutory health insurance (Gesetzliche Krankenversicherung, GKV) funds would be favourable for the GKV system. The introduction of the option of confidential reimbursement prices has been highly controversial, with GKV funds particularly concerned that it would lead to a surge in reimbursement spending. It has also been controversial because of Germany's established position as a champion of price transparency: Germany stands more or less alone as a European country in which discounted reimbursement prices of new originator therapies can be publicly accessed, and it has, until now, held out against attempts to introduce confidential pricing. It should be emphasised here that the situation is different in the case of off-patent medicines, which are predominantly subject to discount contracts between manufacturers and GKV funds, details of which are strictly confidential. Such was the controversy around the proposal to introduce confidential pricing that in the final version of the MFG, thanks mainly to the lobbying of the GKV funds, the confidential pricing option was made so unattractive that the main pharmaceutical industry associations predicted vanishingly small interest in taking it up. The imposition of an additional 9% discount — on top of the negotiated discount — and the requirement to pay back overcharged trade surcharges and sales tax (when paying back the difference between the realised price and the publicly available higher price) made it economically unappealing. And until now, not one single company has requested a confidential reimbursement price. The German Association of Research-Based Pharmaceutical Companies (Verband Forschender Arzneimittelhersteller, VFA) confirmed in an 11 July 2025 press release that no single company had opted for a confidential reimbursement price during the first half of 2025. The controversy does not end there. Soon after the proposal for confidential pricing was put forward as part of the early iterations of the MFG, in an article published by RedaktionsNetzwerk Deutschland (RND) — the joint corporate newsroom of the German Madsack Media Group — it was claimed that the inclusion of confidential pricing in the MFG was directly related to Eli Lilly's decision to build a large new production facility in Alzey, in Germany's Rhineland-Palatinate federal state. It was suggested that Lilly stood to gain in particular from having the option of a confidential reimbursement price, given that Mounjaro is approved both for T2D and obesity, and if the considerably lower price resulting from negotiations between the company and the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) for the T2D indication were to be made publicly available, it would be difficult to maintain a significantly higher price for the obesity indication. In Germany, as in most other European countries, obesity therapies do not, as a rule, benefit from reimbursement. In a later report in Süddeutsche Zeitung, it was claimed that internal government documents had been made available showing that the confidential pricing measure was included in the MFG as a condition for the decision to build the factory. The allegations were dismissed by Lilly and former health minister Karl Lauterbach, although in the meantime, the MFG has been given the widely quoted sobriquet 'Lex Lilly.' Price negotiations between the GKV-Spitzenverband and the company for Mounjaro in T2D have already been concluded, according to the news website of the television news program Tagesschau, although at this stage, there is no official notification of a reimbursement price on the GKV-Spitzenverband website. Predictably, the news of Lilly taking up the option of a confidential reimbursement price for Mounjaro has prompted numerous sensationalist reports in German media, in which Lilly is presented as having used its influence to bring confidential pricing into effect. Tabloid newspaper Bild and popular news weekly Focus both ran articles presenting this view, both also presenting the view that ordinary people paying GKV contributions would have to pick up large additional costs, thanks to the law change. However, the reality is that price transparency remains the rule in Germany, and this is a very isolated exception. And there are unlikely to be many repeats. "Lilly first to opt for confidential reimbursement price in Germany" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error 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
Yahoo
8 hours ago
- Yahoo
Can Eli Lilly Keep Up as NVO Eyes First Oral Obesity Pill Approval?
The two main players in the global obesity market are Eli Lilly LLY and Novo Nordisk NVO, with their respective GLP-1 injectable therapies, Zepbound and Wegovy, leading the field. Although Zepbound entered the market after Wegovy, it has achieved rapid sales growth, fueled by strong demand. LLY had been enjoying a significant edge over Novo Nordisk, after Zepbound outperformed Wegovy in weight-loss efficacy in a head-to-head clinical study. In the first half of 2025, Zepbound generated $5.69 billion in revenues, prompting Lilly to raise its full-year sales guidance to $60-$62 billion from its prior expectation of $58-$61 billion. By comparison, Wegovy recorded sales of $5.41 billion (DKK 36.9 billion) during the same period. Novo Nordisk revised its 2025 sales and operating profit outlook downward due to lower sales expectations from Wegovy as a result of intensified competition, including from compounded GLP-1 alternatives, and slower-than-anticipated market expansion, causing its stock price to plummet. However, Lilly's dominant position in the obesity market faced a setback last week following underwhelming efficacy results from the ATTAIN-1 study, the first of two pivotal phase III studies of its oral GLP-1 candidate, orforglipron. While the study met its primary and all key secondary endpoints across all three doses at 72 weeks, the 12.4% weight loss achieved with the highest 36 mg dose fell short of investor expectations, who had likely anticipated that orforglipron's efficacy would be more comparable to that of currently approved injectable GLP-1 treatments such as Zepbound and Wegovy. Investor sentiment was further dampened by the study's high patient discontinuation rates, stemming from both side effects and personal reasons, raising doubts about orforglipron's long-term utility in chronic obesity management. Given the strategic importance of orforglipron within Lilly's obesity pipeline, the perceived performance gap triggered an 18.6% decline in LLY shares over the past week. In response to LLY's setback, Novo Nordisk stock staged a modest recovery, suggesting a shift in market confidence toward its advancing oral obesity treatment programs. In the past week, NVO shares gained 4.7%. Oral Obesity Pills Emerge as the Next Battleground Eli Lilly's setback with its oral obesity pill has brought focus to oral treatment options for obesity. Oral pills have the potential to significantly reduce the treatment burden for obesity patients, which is expected to boost adherence over injections. NVO has already completed a regulatory filing seeking the approval of a 25 mg oral semaglutide for obesity, currently under review by the FDA. A decision from the regulatory body is expected by year-end. Potential approval would give Novo Nordisk a notable advantage as the sole manufacturer of a marketed oral obesity pill, positioning it to capture significant market share. Novo Nordisk is also developing a small-molecule oral CB1 inverse agonist, monlunabant, in a mid-stage study for obesity. The company is currently gearing up to advance Amycretin, an investigational unimolecular GLP-1 and amylin receptor agonist, for weight management into late-stage development. The phase III program on amycretin is planned to be initiated during the first quarter of 2026. Several other companies, like Viking Therapeutics VKTX, are also making rapid progress in the development of GLP-1-based candidates in their clinical pipeline. Recently, Viking Therapeutics started two late-stage studies evaluating the subcutaneous formulation of its investigational obesity drug, VK2735. A mid-stage study is currently ongoing, evaluating an oral version of this obesity drug, with a data readout expected later this year. LLY's Stock Price, Valuation and Estimates Shares of Eli Lilly have lost 19% so far this year compared with the industry's decline of 8.3%. The stock has also underperformed the sector and the S&P 500 index during the same time frame, as seen in the chart below. LLY Stock Price Movement Image Source: Zacks Investment Research From a valuation standpoint, Lilly's stock is expensive. Going by the price/earnings ratio, the company's shares currently trade at 22.85 forward earnings, higher than 13.71 for the industry. However, the stock is trading much below its five-year mean of 34.54. LLY Stock Valuation Image Source: Zacks Investment Research Estimates for Eli Lilly's 2025 earnings have improved from $21.92 to $22.11 per share in the past 30 days, and estimates for 2026 earnings have declined from $30.84 to $30.74 over the same timeframe. LLY Estimate Movement Image Source: Zacks Investment Research Eli Lilly currently carries a Zacks Rank #3 (Hold). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Novo Nordisk A/S (NVO) : Free Stock Analysis Report Eli Lilly and Company (LLY) : Free Stock Analysis Report Viking Therapeutics, Inc. (VKTX) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research
