MKI67

Ribociclib (Kisqali) plus aromatase inhibitor (AI) recommended for HR+/HER2- early breast cancer (EBC) node-positive and high-risk node-negative patients, as studied in the NATALEE trial and indicated by the FDA1 Recommendation comes after recent FDA approval and positive CHMP Opinion for ribociclib (Kisqali) to help reduce the risk of recurrence in EBC Ribociclib (Kisqali) is also the only Category 1 preferred CDK4/6 inhibitor for first-line treatment of patients with HR+/HER2- metastatic breast cancer in combination with an AI1 EAST HANOVER, N.J., Oct. 24, 2024 /PRNewswire/ -- This month, the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for breast cancer were updated to recommend ribociclib (Kisqali®) as a Category 1 preferred CDK4/6 inhibitor (CDK4/6i) adjuvant therapy for patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer (EBC) in combination with an aromatase inhibitor (AI)1. Ribociclib (Kisqali) is the only CDK4/6i recommended for both all node-positive disease as well as for patients with no nodal involvement with high-risk disease characteristics, such as tumor size >5 cm, or for tumors sized 2-5 cm, either Grade 2 with high genomic risk/Ki-67 ≥20% or Grade 31. "These evidence-based guidelines are helpful to clinicians when determining optimal treatment options for patients," said Shreeram Aradhye, M.D., President, Development and Chief Medical Officer, Novartis. "Importantly, the NCCN Guideline recommendation of ribociclib in this broad population reaffirms the importance of offering eligible patients with early breast cancer, including those with limited nodal involvement and high-risk N0 disease, a CDK4/6i treatment like ribociclib in addition to endocrine therapy to reduce their risk of recurrence." A Category 1 recommendation by the NCCN Guidelines indicates high levels of clinical evidence and uniform consensus among NCCN on ribociclib (Kisqali) as an appropriate treatment for these patients. This recommendation comes after the presentation of longer-term results from the Phase III NATALEE trial at the European Society for Medical Oncology (ESMO) Congress 2024, which showed a deepening efficacy benefit beyond the Kisqali treatment duration in a broad population of patients, including those with node-negative disease; as well as the recent FDA approval and CHMP positive opinion for Kisqali in the EBC indication2. The updated guidelines, consistent with the FDA indication per the NATALEE trial, approximately double the number of patients that could benefit from treatment with a CDK4/6i in the adjuvant setting3. NCCN Guidelines also continue to recommend ribociclib (Kisqali) as the only Category 1 preferred CDK4/6i for first-line treatment of patients with HR+/HER2- metastatic breast cancer in combination with an AI; ribociclib (Kisqali) is also recommended as a Category 1 preferred regimen for first- and subsequent-line therapies** in HR+/HER2- MBC in combination with fulvestrant1. To access NCCN Guidelines, visit . * Adjuvant treatment with Kisqali has only been studied in high-risk patients. ** If CDK4/6 inhibitor was not previously used. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. About Kisqali® (ribociclib) Kisqali ® (ribociclib) is a selective cyclin-dependent kinase inhibitor, a class of drugs that help slow the progression of cancer by inhibiting two proteins called cyclin-dependent kinase 4 and 6 (CDK4/6). These proteins, when over-activated, can enable cancer cells to grow and divide too quickly. Targeting CDK4/6 with enhanced precision may play a role in ensuring that cancer cells do not continue to replicate uncontrollably. In addition to the recent FDA approval of Kisqali for EBC patients in the US and CHMP positive opinion in Europe, regulatory reviews for Kisqali as an EBC treatment are ongoing worldwide. Kisqali has been approved as a treatment for metastatic breast cancer (MBC) patients in 99 countries worldwide, including by the US FDA and the European Commission4,5. In the US, Kisqali is indicated for the treatment of adults with HR+/HER2- advanced or MBC in combination with an AI as initial ET or fulvestrant as initial ET or following disease progression on ET in post-menopausal women or in men4. In MBC, Kisqali has consistently demonstrated statistically significant overall survival benefit across three Phase III trials6-16. Kisqali was developed by Novartis under a research collaboration with Astex Pharmaceuticals. Please see full Prescribing Information for Kisqali, available at About Novartis in Breast Cancer For more than 35 years, Novartis has been at the forefront of driving scientific advancements for people touched by breast cancer and improving clinical practice in collaboration with the global community. With one of the most comprehensive breast cancer portfolios and pipeline, Novartis leads the industry in discovery of new therapies and combinations in HR+/HER2- breast cancer, the most common form of the disease. Indication What is KISQALI? KISQALI® (ribociclib) is a prescription medicine used to treat adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer: in combination with an aromatase inhibitor for stage II and III early breast cancer with a high risk of coming back that has gotten worse or has spread to other parts of the body (advanced or metastatic breast cancer) in combination with: an aromatase inhibitor as the first endocrine-based therapy; or fulvestrant as the first endocrine-based therapy or following disease progression on endocrine therapy It is not known if KISQALI is safe and effective in children. IMPORTANT SAFETY INFORMATION KISQALI may cause serious side effects, including: Lung problems. KISQALI may cause severe or life-threatening inflammation of the lungs during treatment that may lead to death. Tell your health care provider right away if you have any new or worsening symptoms, including: trouble breathing or shortness of breath cough with or without mucus chest pain Severe skin reactions. Tell your health care provider or get medical help right away if you get severe rash or rash that keeps getting worse; reddened skin; flu-like symptoms; skin pain or burning, blistering of the lips, eyes, or mouth, blisters on the skin or skin peeling, with or without fever. Heart rhythm problems (QT prolongation). KISQALI can cause a heart problem known as QT prolongation. This condition can cause an abnormal heartbeat and may lead to death. Your health care provider should check your heart and do blood tests before and during treatment with KISQALI Tell your health care provider right away if you have a change in your heartbeat (a fast or irregular heartbeat), or if you feel dizzy or faint Liver problems. KISQALI can cause serious liver problems. Your health care provider should do blood tests to check your liver before and during treatment with KISQALI. Tell your health care provider right away if you get any of the following signs and symptoms of liver problems: yellowing of your skin or the whites of your eyes (jaundice) dark or brown (tea-colored) urine feeling very tired loss of appetite pain on the upper right side of your stomach area (abdomen) bleeding or bruising more easily than normal Low white blood cell counts (neutropenia). Low white blood cell counts are very common during treatment with KISQALI and may result in infections that may be severe. Your health care provider should check your white blood cell counts before and during treatment with KISQALI. Tell your health care provider right away if you have signs and symptoms of low white blood cell counts or infections, such as fever and chills. Your health care provider may tell you to decrease your dose, temporarily stop, or completely stop taking KISQALI if you develop certain serious side effects during treatment with KISQALI. What should I tell my health care provider before taking KISQALI? Before you take KISQALI, tell your health care provider if you: have any heart problems, including heart failure, irregular heartbeats, and QT prolongation have ever had a heart attack have a slow heartbeat (bradycardia) have high blood pressure that is not controlled have decreased thyroid gland (hypothyroidism) have problems with the amount of potassium, calcium, phosphorus, or magnesium in your blood have fever, chills, or any other signs or symptoms of infection have liver problems have kidney problems are pregnant, or plan to become pregnant. KISQALI can harm your unborn baby If you are able to become pregnant, your health care provider should do a pregnancy test before you start treatment with KISQALI Females who are able to become pregnant and who take KISQALI should use effective birth control during treatment and for at least 3 weeks after the last dose of KISQALI Talk to your health care provider about birth control methods that may be right for you during this time If you become pregnant or think you are pregnant, tell your health care provider right away are breastfeeding or plan to breastfeed. It is not known if KISQALI passes into your breast milk. Do not breastfeed during treatment with KISQALI and for at least 3 weeks after the last dose of KISQALI Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. KISQALI and other medicines may affect each other, causing side effects. Know the medicines you take. Keep a list of them to show your health care provider or pharmacist when you get a new medicine. What should I avoid while taking KISQALI? Avoid eating grapefruit and avoid drinking grapefruit juice during treatment with KISQALI since these may increase the amount of KISQALI in your blood. The most common side effects of KISQALI in people with early breast cancer include: decreased white blood cell counts decreased red blood cell counts increased liver function tests infections increased kidney function test decreased platelet counts nausea headache tiredness The most common side effects of KISQALI in people with advanced or metastatic breast cancer include: decreased white blood cell counts decreased red blood cell counts increased liver function tests infections nausea increased kidney function test tiredness decreased platelet counts diarrhea vomiting headache constipation hair loss cough rash back pain low blood sugar level KISQALI may cause fertility problems in males, which may affect your ability to father a child. Talk to your health care provider if this is a concern for you. Tell your health care provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of KISQALI. For more information, ask your health care provider or pharmacist. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit , or call 1-800-FDA-1088. Please see accompanying full Prescribing Information including Patient Information . Disclaimer This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "potential," "can," "will," "plan," "may," "could," "would," "expect," "anticipate," "look forward," "believe," "committed," "investigational," "pipeline," "launch," or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise. About Novartis Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people's lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide. Reimagine medicine with us: Visit us at and , and connect with us on LinkedIn, LinkedIn US, Facebook, X/Twitter, X/Twitter US and Instagram. References NCCN Guidelines. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) - Breast Cancer. Accessed October 2024. Fasching PA. Adjuvant Ribociclib (RIB) Plus Nonsteroidal Aromatase Inhibitor (NSAI) in Patients (Pts) With HR+/HER2− Early Breast Cancer (EBC): 4-Year Outcomes From the NATALEE Trial. LBA13. Proffered Paper presented at the European Society for Medical Oncology Congress; September 16, 2024; Barcelona, Spain. Tarantino P, Rugo HS, Curigliano G, et al. Characteristics of real-world NATALEE and monarchE eligible populations: A US electronic health records database analysis. Poster presented at the European Society for Medical Oncology Congress; September 13-17, 2024; Barcelona, Spain. Kisqali (ribociclib) Prescribing information. East Hanover, New Jersey, USA: Novartis Pharmaceuticals Corporation; October 2024. Kisqali. Summary of product characteristics (SmPC). Novartis Europharm Limited; 2017. Accessed September 2024. . Yardley DA, Yap YS, et al. Pooled exploratory analysis of survival in patients (pts) with HR+/HER2- advanced breast cancer (ABC) and visceral metastases (mets) treated with ribociclib (RIB) + endocrine therapy (ET) in the MONALEESA (ML) trials. Poster presented at the European Society of Medical Oncology Congress; September 9-13, 2022; Paris, France. Neven P, Fasching PA, et al. Updated overall survival (OS) results from the first-line (1L) population in the Phase III MONALEESA-3 trial of postmenopausal patients with HR+/HER2- advanced breast cancer (ABC) treated with ribociclib (RIB) + fulvestrant (FUL). Mini oral presented at the European Society for Medical Oncology Breast Cancer Congress; May 4, 2022; Paris, France. Hortobagyi GN, Stemmer SM, Burris HA, et al. Overall Survival with Ribociclib plus Letrozole in Advanced Breast Cancer. N Engl J Med. 2022;386(10):942-950. doi:10.1056/NEJMoa2114663 Hortobagyi GN, et al. Overall survival (OS) results from the phase III MONALEESA (ML)-2 trial of postmenopausal patients with hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2−) advanced breast cancer (ABC) treated with endocrine therapy (ET) ± ribociclib. Proffered paper presented at the European Society of Medical Oncology Congress; September 16-21, 2021; Lugano, Switzerland. Im S-A, Lu Y-S, Bardia A, et al. Overall survival with ribociclib plus endocrine therapy in breast cancer. N Engl J Med. 2019;381(4):307-316. doi:10.1056/nejmoa1903765 Slamon DJ, Neven P, Chia S, et al. Overall Survival with Ribociclib plus Fulvestrant in Advanced Breast Cancer. N Engl J Med. 2020;382(6):514-524. doi:10.1056/NEJMoa1911149 Slamon DJ, Neven P, Chia S, et al. Overall survival (OS) results of the Phase III MONALEESA-3 trial of postmenopausal patients (pts) with hormone receptor–positive (HR+), human epidermal growth factor 2–negative (HER2−) advanced breast cancer (ABC) treated with fulvestrant (FUL) ± ribociclib (RIB). Presented at the European Society of Medical Oncology Congress; September 29, 2019; Barcelona, Spain. Slamon DJ, Neven P, Chia S, et al. Updated overall survival (OS) results from the Phase III MONALEESA-3 trial of postmenopausal patients (pts) with HR+/HER2− advanced breast cancer (ABC) treated with fulvestrant (FUL) ± ribociclib (RIB. Presented at the American Society of Clinical Oncology Annual Meeting; June 5, 2021; Chicago, USA. Tripathy D, Im S-A, Colleoni M, et al. Updated overall survival (OS) results from the phase III MONALEESA-7 trial of pre- or perimenopausal patients with HR+/HER2− advanced breast cancer (ABC) treated with endocrine therapy (ET) ± ribociclib. Presented at the San Antonio Breast Cancer Symposium; December 9, 2020; San Antonio, USA. Yardley D, Nusch A, Yap YS, et al. Overall survival (OS) in patients (pts) with advanced breast cancer (ABC) with visceral metastases (mets), including those with liver mets, treated with ribociclib (RIB) plus endocrine therapy (ET) in the MONALEESA (ML) -3 and -7 trials. Presented at the American Society of Clinical Oncology (ASCO) Annual Meeting; June 2020; Chicago, USA. O'Shaughnessy J, Stemmer SM, Burris HA, et al. Overall survival subgroup analysis by metastatic site from the Phase III MONALEESA-2 study of first-line ribociclib + letroz21ole in postmenopausal patients with HR+/HER2− advanced breast cancer. Presented at the San Antonio Breast Cancer Symposium; December 7-10, 2021; San Antonio, USA. CONTACT: Novartis Media Relations: E-mail: [email protected] North America: Michael Meo, +1 862 274 5414 Novartis Investor Relations: E-mail: [email protected] North America: Sloan Simpson, +1 862 345 4440 Jonathan Graham, +1 201 602 9921 Parag Mahanti, +1 973 876 4912 SOURCE Novartis Pharmaceuticals Corporation WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Roche’s CINtec PLUS Cytology is the only FDA-approved and CE-marked dual-stain test to triage human papillomavirus (HPV)-positive cervical cancer screening test results Dual-stain biomarkers aid in detection of cervical precancer and may reduce the number of women who undergo unnecessary colposcopy procedures while allowing earlier intervention for those who are at higher risk of developing cervical cancer.This recognition follows the American Society for Colposcopy and Cervical Pathology (ASCCP)’s recent inclusion of dual-stain testing in cervical cancer screening guidelines, as well as other WHO prequalifications of Roche’s cobas HPV test Basel, 23 September 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the World Health Organization (WHO) has included dual-stain cytology testing in its cervical cancer prevention guideline.1 The Roche CINtec® PLUS Cytology test is the only FDA-approved and CE-marked dual-stain test that helps identify human papillomavirus (HPV)-positive individuals who are most at risk of developing cervical precancer and cancer. The WHO joins the American Society for Colposcopy and Cervical Pathology (ASCCP), which in March also updated its cervical cancer screening guidelines2 to include dual-stain as a triage test for HPV-positive individuals. If the dual-stain test is positive, the patient is at higher risk of having or developing precancer or cancer, and clinicians should recommend immediate colposcopy. However, if the dual-stain test is negative, the risk of precancer is low and individuals may follow up by retesting at a later time to determine if their body has taken care of the infection and eliminated the risk on its own. This may result in fewer women unnecessarily undergoing colposcopy procedures. “Adding dual-stain cytology to the WHO guidelines further reinforces the value of our biomarker-based CINtec PLUS Cytology test to identify patients with an elevated risk of cervical cancer,” said Matt Sause, CEO of Roche Diagnostics. “HPV infections can cause cervical cancer, a potentially deadly disease that is highly preventable. Consequently, it is critical to determine who is most at risk.” The CINtec PLUS Cytology test can simultaneously detect when two biomarkers (p16 and Ki-67) are present within the same cell – a strong indicator that it is undergoing transformation and may turn cancerous. By identifying those individuals who are at higher risk of developing cervical disease, CINtec PLUS Cytology helps provide labs, clinicians and patients with important information to guide patient management. This could reduce the number and frequency of follow-up visits, saving worry, time and money. The test can be performed using the same liquid sample that is used for HPV or Pap cytology testing, eliminating the need for additional or repeat sample collection. The revised WHO guidelines represent an important step forward in achieving the organisation’s three cervical cancer elimination goals3, and a catalyst for ensuring that 90% of those identified with cervical disease receive appropriate treatment. With the recent news that the WHO has awarded prequalification designation to the cobas® HPV test on the cobas 4800, Roche’s entire portfolio of HPV tests on the 4800, 5800, 6800 and 8800 systems is now WHO prequalification-approved for both clinician-collected and self-collected samples. About the Roche Cervical Cancer PortfolioHPV is the known cause of more than 95% of all cervical cancers.4 Roche’s cervical cancer portfolio includes the cobas HPV test, used for primary screening and co-testing. While Pap cytology can potentially detect abnormalities in the cervix, cobas HPV detects 14 types of high-risk HPV genotypes that put patients at higher risk of developing cervical cancer. It includes results for HPV 16, HPV 18 and 12 other high-risk pooled genotypes.3 The HPV self-collection solution is approved for use with Roche's cobas HPV test. The cobas HPV test runs on the cobas 4800 and the fully automated cobas 5800/6800/8800 Systems, which offer the fastest time to results, providing up to 96 results in about three hours, and 384 results for the cobas 6800 System and 1,056 results for the cobas 8800 System in an eight hour shift. The portfolio also includes CINtec PLUS Cytology, the only FDA-approved dual-stain cytology product and CINtec Histology, the only FDA-cleared p16 biomarker technology that can help pathologists confirm the presence of pre-cancerous cervical lesions. The CINtec PLUS Cytology test can run on the BenchMark ULTRA IHC/ISH system. In countries accepting the CE mark, the CINtec PLUS Cytology test can be used to triage HPV-positive results. The IMPACT trial, used to validate the clinical performance of the Roche cervical cancer portfolio, had representation from diverse patient segments, including 21 percent Black, 24 percent Hispanic-Latino and 0.3 percent American Indian or Alaskan Native participants.5 This diversity was critical to accurately assess the performance of the cobas HPV test and dual stain cytology in patient populations with higher incident rates of HPV. Learn more now: http://diagnostics.roche.com. Roche is piloting a disease management software called navify® Cervical Screening. It aims to support health systems to increase adherence to clinical guidelines, reduce under- and over-testing and optimise healthcare resources with an organised approach to screening. About Roche Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice. For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com. All trademarks used or mentioned in this release are protected by law.References[1] World Health Organization. WHO guideline for screening and treatment of cervical pre-cancer lesions for cervical cancer prevention: use of dual-stain cytology to triage women after a positive test for human papillomavirus (‎HPV)‎. Brochure [Internet; updated 2024 June 4; cited 2024 July 3] Available from: https://www.who.int/publications/i/item/9789240091658 [2] American Society for Colposcopy and Cervical Pathology [Internet; updated 2024 March 11 ; cited August 14] Available from: https://www.asccp.org/enduring-guidelines-process[3] World Health Organization. Global strategy to accelerate the elimination of cervical cancer as a public health problem. Article [Internet; updated 2020 November 17; cited 2023 Jan 3] Available from: https://www.who.int/publications/i/item/9789240014107[4] National Cancer Institute. HPV and Cancer. Fact sheet [Internet; cited 2024 June 4] https://www.cancer.gov/about-cancer/causes-prevention/risk/infectious-agents/hpv-and-cancer#:~:text=Sexually%20transmitted%20HPV%20types%20fall,for%20most%20HPV%2Drelated%20cancers[5] Safaeian M, Wright TC Jr, Stoler MH, Ranger-Moore J, Rehm S, Aslam S, Fang Q, Volkir P, Ridder R. The IMproving Primary Screening And Colposcopy Triage trial: human papillomavirus, cervical cytology, and histopathologic results from the baseline and 1-year follow-up phase. Am J Obstet Gynecol. 2021 Sep;225(3):278.e1-278.e16. doi: 10.1016/j.ajog.2021.03.047. Epub 2021 Apr 20. PMID: 33852886 Roche Global Media RelationsPhone: +41 61 688 8888 / e-mail: media.relations@roche.com Hans Trees, PhDPhone: +41 79 407 72 58Sileia UrechPhone: +41 79 935 81 48 Nathalie AltermattPhone: +41 79 771 05 25Lorena CorfasPhone: +34 620 29 25 51 Simon GoldsboroughPhone: +44 797 32 72 915Karsten KleinePhone: +41 79 461 86 83 Nina MählitzPhone: +41 79 327 54 74Kirti PandeyPhone: +49 172 6367262 Yvette PetillonPhone: +41 79 961 92 50Dr. Rebekka SchnellPhone: +41 79 205 27 03 Attachment 23092024_MR_CINtec PLUS_en

Just six months after closing its Google Ventures-led series A, Pelage Pharmaceuticals has gone back to the VC for more. The hair–loss-focussed biotech raised a $14-million A-1 round from GV on Tuesday and also announced that the first patients have been dosed in a Phase IIa trial of its androgenetic alopecia hopeful, PP405. According to Pelage, the latest funding was triggered by proof of mechanism and target engagement data from the Phase I study of PP405, a mitochondrial pyruvate carrier inhibitor that upregulates lactate dehydrogenase to activate stem cells and trigger hair growth.The topical treatment was well-tolerated and led to a statistically significant increase in Ki67 signalling — indicative of a proliferative response of the hair follicle stem cells — compared to baseline at one week, and also showed evidence of newly emerging hair germs.Cathy Friedman, executive venture partner at GV, commented that the firm is “encouraged by Pelage's prior Phase I data readouts and robust clinical safety profile.” She also serves on the biotech’s board.The VC led the company’s $16.8-million series A in February along with Main Street Advisors, Visionary Ventures and YK BioVentures, who all also participated in the A-1 round.Study protocolTuesday’s financing will support the Phase II programme, which will randomise 60 men and women to receive either a daily topical application of PP405 or placebo. Chief Medical Officer Qing Yu Christina Weng added that the trial will “include women and men of all skin tones and hair textures, which has not always been the case in hair loss studies."According to ClinicalTrials.org, the study is expected to conclude in December.