MKI67

SAN DIEGO, March 19, 2024 (GLOBE NEWSWIRE) -- Bionano Genomics, Inc. (Nasdaq: BNGO) today announced the publication of a study of optical genome mapping (OGM) in hereditary breast and ovarian cancer (HBOC) syndrome showing that when tumors exhibited higher overall numbers of structural variations (SVs) they tended to have more mutated genes and altered signaling pathways, which may correlate with poor prognosis, tumor progression and chemotherapy resistance. Researchers also found that OGM was able to detect chromothripsis events and novel gene fusions in cancer tissues with high accuracy, including novel gene fusions that were not detected by other methods. HBOC syndrome is estimated to cause 5-10% of all breast cancers and is commonly characterized by harmful germline mutations in the BRCA1 or BRCA2 genes. Due to limitations inherent in common methods of genome analysis, researchers have limited knowledge regarding the potential impact of structural abnormalities and SV heterogeneity in HBOC-related cancers. The study authors selected OGM for this analysis due to its ability to detect multiple classes of SVs with genome-wide coverage, high resolution and accuracy. Study authors categorized the HBOC-related breast cancer samples into two groups, SVhigh and SVlow, based on the number of SVs detected by OGM, high or low Ki-67 expression, and the number of mutated genes and altered signaling pathways. The authors noted that SVhigh samples were associated with higher Ki-67 expression and higher homologous recombination deficiency (HRD) scores, indicating that genetic alterations may have potential predictive and therapeutic significance. The SVhigh samples also showed higher numbers of chromothripsis events and novel gene fusions than the SVlow samples. Eight novel gene fusions were identified by OGM, including three that had not previously been detected by other methods of analysis. These gene fusions may be involved in drug resistance and tumor development. “We are pleased to see the publication of this study, which highlights OGM as a promising tool for detecting novel variants in HBOC-related breast cancer that have oncogenic potential. We believe the comprehensive assessment of the role SVs play in breast cancers with abnormal DNA repair functions might expand our current understanding of disease progression and precision medicine in breast cancer," commented Erik Holmlin, PhD, president and chief executive officer of Bionano. The paper is available at: About Bionano Bionano is a provider of genome analysis solutions that can enable researchers and clinicians to reveal answers to challenging questions in biology and medicine. The Company’s mission is to transform the way the world sees the genome through OGM solutions, diagnostic services and software. The Company offers OGM solutions for applications across basic, translational and clinical research. Through its Lineagen, Inc. d/b/a Bionano Laboratories business, the Company also provides diagnostic testing for patients with clinical presentations consistent with autism spectrum disorder and other neurodevelopmental disabilities. The Company also offers an industry-leading, platform-agnostic software solution, which integrates next-generation sequencing and microarray data designed to provide analysis, visualization, interpretation and reporting of copy number variants, single-nucleotide variants and absence of heterozygosity across the genome in one consolidated view. The Company additionally offers nucleic acid extraction and purification solutions using proprietary isotachophoresis (ITP) technology. For more information, visit , or . Bionano’s OGM products are for research use only and not for use in diagnostic procedures. Forward-Looking Statements of Bionano This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “believe,” “may,” “potential” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) convey uncertainty of future events or outcomes and are intended to identify these forward-looking statements. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the ability and utility of OGM to detect SVs in samples suspected of HBOC syndrome; and the ability and utility of OGM to detect chromothripsis events and novel gene fusions in cancer tissues with high accuracy, including novel gene fusions that were not detected by other methods. Each of these forward-looking statements involves risks and uncertainties. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include the risks and uncertainties associated with: the impact of geopolitical and macroeconomic developments, such as recent and potential future bank failures, supply chain disruptions, global pandemics, inflation and the ongoing conflicts between Ukraine and Russia and Israel and Hamas, on our business and the global economy; general market conditions; the failure of OGM to detect SVs in samples suspected of HBOC syndrome; the failure of OGM to detect chromothripsis events and novel gene fusions in cancer tissues with high accuracy, including novel gene fusions that were not detected by other methods; study results that differ or contradict the results reported in the study referenced in this press release; changes in the competitive landscape and the introduction of competitive technologies or improvements to existing technologies; changes in our strategic and commercial plans; our need and ability to obtain sufficient financing to fund our strategic plans and commercialization efforts, our ability to effectively manage our uses of cash, and our ability to continue as a “going concern”; the ability of medical and research institutions to obtain funding to support adoption or continued use of our technologies; and the risks and uncertainties associated with our business and financial condition in general, including the risks and uncertainties described in our filings with the Securities and Exchange Commission, including, without limitation, our Annual Report on Form 10-K for the year ended December 31, 2023 and in other filings subsequently made by us with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. We do not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise. CONTACTS Company Contact: Erik Holmlin, CEO Bionano Genomics, Inc. +1 (858) 888-7610 eholmlin@bionano.com Investor Relations: David Holmes Gilmartin Group +1 (858) 888-7625 IR@bionano.com

Updated American Society of Colposcopy and Cervical Pathology ( ASCCP) guidelines recognize the importance of dual-stain biomarkers in managing early diagnosis of HPV- positive cervical precancer and cancer. Earlier detection may significantly reduce the number of women expected to be diagnosed with cervical cancer. CINtec® PLUS Cytology is the only FDA-approved dual-stain triage test for HPV-positive cervical cancer screening results. INDIANAPOLIS, March 11, 2024 /PRNewswire/ -- Roche Diagnostics today announced the release of new guidelines from ASCCP and other members of the Enduring Guidelines for Cervical Cancer Screening and Management Committee that now recognize dual-stain biomarkers as an important technology in helping clinicians triage patients to determine if their human papillomavirus (HPV) infection is transforming into cervical pre-cancer. Roche's CINtec® PLUS Cytology is the only FDA-approved dual-stain triage test for HPV-positive cervical cancer screening results. Continue Reading Dual stain is a robust marker of CIN3+ risk and can be incorporated into clinical management strategies, according to the guidelines.∗ Existing clinical decision support tools (e.g., the ASCCP app) plan to incorporate these recommendations for use of DS. The guidelines examine data from the Kaiser Permanente Northern California cohort and the STudying Risk to Improve DisparitiES study, and outline new recommendations on how to manage patients using dual-stain technology. The guidelines also note that compared with cytology, dual stain requires fewer colposcopies and detects cervical intraepithelial neoplasia grade 3 or greater earlier. "There is robust evidence that proves the use of dual-staining to risk stratify and triage patients is superior to cytology, making it a valuable tool for OB-GYNs," said Dr. Tamera Paczos, an OB-GYN and senior vice president, chief laboratory officer for BioReference, which operates large reference facilities nationwide. "Dual-stain triage provides excellent discrimination between HPV-positive individuals requiring direct colposcopy and those who can be safely followed in one year. It can provide peace of mind to women who are often asked to wait a year until their next screening before knowing whether their HPV infection may resolve on its own, or remain persistent and transform into cancer." When detected at an early stage, the five-year survival rate for women with invasive cervical cancer is 92%.1 In the IMPACT clinical trial, testing with CINtec PLUS Cytology as a triage detected cervical disease earlier than Pap cytology in seven out of 10 women who were already identified as HPV positive.2,3 The biomarker-based CINtec PLUS Cytology test showed a significantly higher sensitivity in detecting cervical pre-cancers, compared to Pap cytology when used for the triage of HPV-positive women. This allows clinicians to treat disease earlier, a critical factor in improving cancer patient outcomes. "For the first time, ASCCP has included dual-stain testing as an option for the triage of HPV-positive women in HPV primary screening and co-testing settings," said Laura Shields, chief medical partner, Pathology Oncology at Roche Diagnostics. "With more advanced technologies, such as dual-stain, better access and more awareness, we can change the course of this disease with earlier detection, save lives and eventually eliminate cervical cancer." CINtec® PLUS Cytology detects the simultaneous presence within a single cell of the p16 and Ki-67 biomarkers, which are associated with HPV infections that are transforming and may lead to cervical cancer. A positive test result signals that a patient has a significantly higher risk for the disease. The dual-stain test is performed with the same sample as used for HPV or Pap cytology tests, so it does not require a repeat office visit for the patient. The Roche cobas ® HPV Test is the only test approved by the FDA for use with CINtec PLUS. ∗Please see ASCCP website (acssp.org) for full details on the updated guidelines. About the Roche Cervical Cancer Portfolio Roche's cervical cancer portfolio includes the cobas HPV Test, used for primary screening and co-testing, which tests for 14 types of high-risk HPV genotypes in cervical cancer. It includes results for HPV 16, HPV 18 and 12 other high-risk pooled genotypes.4 The portfolio also includes CINtec PLUS Cytology, the only FDA-approved dual-stain product and CINtec® Histology, the only FDA-cleared p16 biomarker technology that can help pathologists confirm the presence of precancerous cervical lesions. The IMPACT trial design, used to validate the clinical benefits of the Roche cervical cancer portfolio, had representation from diverse patient segments, including 21 percent Black, 24 percent Hispanic-Latino and .3 percent American Indian or Alaskan Native participants. This diversity was critical to accurately assess the performance of dual stain in patient populations with higher incident rates of HPV.5 About Roche Founded in Basel, Switzerland, in 1896 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. In recognizing our endeavor to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for the thirteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work. 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 . All trademarks used or mentioned in this release are protected by law. Roche Diagnostics U.S. Media Relations Krystina Monaco (317) 850-7521 [email protected] Lori McLaughlin (463) 207-2395 [email protected] [email protected] SOURCE Roche Diagnostics

- Potent topical MPC inhibitor, based on discovery of a metabolic switch, reawakens dormant hair follicle stem cells to stimulate hair growth - PP405 demonstrates statistically significant activation of Ki67 in the hair follicle, a well-established marker of stem cell proliferation LOS ANGELES, March 9, 2024 /PRNewswire/ -- Pelage Pharmaceuticals, a clinical-stage regenerative medicine company pioneering a new generation of treatments for hair loss, today presented positive translational and Phase 1 clinical data demonstrating the company's novel small molecule therapy PP405 reactivates dormant hair follicle stem cells to trigger hair growth. Data were presented in a late-breaking oral session of the American Academy of Dermatology (AAD) 2024 Annual Meeting in San Diego, titled Inhibition of pyruvate oxidation activates human hair follicle stem cells ex vivo. "The translational data derived from our ex vivo studies on human facelift skin have been further validated in a Phase 1 first-in-human clinical trial demonstrating PP405 effectively reactivates dormant hair follicle stem cells," said Daniel Gil, Ph.D., CEO of Pelage Pharmaceuticals. "This therapy represents an exciting new option for not only treating but reversing hair loss. We look forward to advancing PP405 to Phase 2 clinical studies this year." PP405 is a potent topical mitochondrial pyruvate carrier (MPC) inhibitor that acts on the cellular metabolic pathway to upregulate lactate dehydrogenase (LDH), which stem cells are particularly sensitive to, resulting in their activation and hair growth. Data presented at AAD showed in human facelift skin, single topical applications of 0.006% and 0.06% PP405 led to an increase in LDH activity in hair follicle stem cells within 24 hours. The LDH activity corresponded with a significant increase in Ki67 signal in the hair bulge, indicating a proliferative response of the hair follicle stem cells. The findings demonstrated proof of mechanism in human explanted skin consistent with the results in animal models. The data informed Pelage's Phase 1 clinical trial that concluded in January 2024, which demonstrated that PP405 was safe and well-tolerated, with the target pharmacokinetic profile achieved. Additionally, the Phase 1 study demonstrated proof of mechanism and target engagement in patients with androgenetic alopecia. There was a statistically significant increase in the Ki67 signal compared to baseline after just seven days of 0.05% PP405 topical treatment. Evidence of newly emerging hair germs – the hallmark of the telogen to anagen transition - was also observed. The topical molecule also received positive formulation reviews from patients. "We are incredibly excited about this data, and PP405 offers an opportunity to change the landscape of alopecia treatment through directly targeting hair follicle stem cells at the source through a clear mechanistic pathway," said Qing Yu Christina Weng, M.D., CMO of Pelage Pharmaceuticals. "The Phase 1b study of PP405 demonstrates a strong safety profile, confirms daily topical dosing with no detectable drug levels in the blood, and demonstrates proof of mechanism with statistically significant activation of hair follicle stem cells. We can also see the structural architecture of the follicle on biopsy moving through the hair cycle from resting to growing as the stem cells become activated." Pelage will begin its multi-center Phase 2a trial of PP405 in mid-2024, recruiting both men and women with androgenetic alopecia. PP405 may also have applications for other forms of alopecia, including telogen effluvium (stress-induced hair loss) and chemotherapy-induced hair loss. About Pelage Pharmaceuticals Pelage Pharmaceuticals is a clinical-stage regenerative medicine company developing novel treatments for hair loss including androgenetic alopecia and chemotherapy-induced-alopecia. With a focus on molecular and stem cell biology, Pelage is advancing a new class of treatments designed to reactivate dormant hair follicle stem cells and restore the body's ability to naturally grow hair. Its lead program, PP405, is currently in clinical trials. Through its rigorous scientific foundation, topical formulation, and novel mechanism of action, Pelage is pioneering first-in-class hair growth solutions for people of all hair types experiencing hair loss. About PP405 PP405 is a novel, non-invasive, topical small molecule designed to reactivate dormant hair follicle stem cells and restart hair growth. Through a regenerative medicine approach, the treatment focuses on addressing the metabolic processes that regulate the activation and inactivation phases of hair follicle stem cells. Early results from a Phase 1 trial show that PP405 was well-tolerated and demonstrated statistically significant activation of hair follicle stem cells. In 2018, Pelage Pharmaceuticals licensed the intellectual property to PP405 and related topical small molecules from the UCLA Technology Development Group. SOURCE Pelage Pharmaceuticals