Abortion, Spontaneous

The world's first non-surgical cervical HSIL treatment validated by an international Phase III clinical study with proven efficacy; The response rate increased by 89.4% compared to the placebo control group, with a low incidence of adverse events; The China new drug application submission is expected in Q2 2024, while ex-China product development is in active progress. SHANGHAI, March 18, 2024 /PRNewswire/ -- Asieris Pharmaceuticals (Stock Code: 688176.SH), a global biopharmaceutical leader in the discovery, development, and commercialization of innovative drugs for genitourinary tumors and related diseases announced that the multicenter Phase III global clinical study data of its non-surgical treatment for cervical HSIL product APL-1702 demonstrated significant efficacy and good safety profile, with new advancements in clearance rate of high-risk HPV16 and/or HPV18. Key data from the study were presented in oral presentations at the 2024 European Research Organization on Genital Infection and Neoplasia (EUROGIN) Congress and the 2024 Society of Gynecologic Oncology (SGO) Annual Meeting. APL-1702 is a pioneering cold light photodynamic drug-device combination product, used as a non-surgical therapy for treating cervical HSIL. This study is a prospective, randomized, double-blinded, placebo-controlled multicenter Phase III global clinical study designed to evaluate the efficacy and safety of APL-1702 for the treatment of cervical HSIL. Primary endpoint of the study is the proportion of responders at 6 months after the initial treatment. The study is led by Dr. Jinghe Lang, an academician at Peking Union Medical College Hospital, Chinese Academy of Medical Sciences. Response is defined as the conversion of cervical epithelial tissue pathology to normal or the conversion to low-grade squamous intraepithelial lesion (LSIL) while achieving baseline HPV clearance. According to the study results, between November 2020 and July 2022, a total of 402 eligible patients from various countries including China, Germany, the Netherlands et al. were randomized and enrolled in this study. The response rate in the APL-1702 treatment group showed a statistically significant improvement of 89.4% (41.1% vs. 21.7%, p = 0.0001) compared to that in the placebo control group, indicating a remarkable therapeutic effect. Additionally, APL-1702 showed an improved clearance rate of high-risk HPV16 and/or HPV18, with a 103.9% increase in the APL-1702 treatment group compared to the control group (31.4% vs. 15.4%)[1]. The incidence of treatment-emergent adverse events (TEAEs) was comparable between the treatment group and the control group, with the majority being mild and self-healing without requiring intervention. The occurrence rates of treatment-related adverse events (TRAEs) and serious adverse events (SAEs) were both low in both groups[2]. According to the "Global Cancer Statistics 2020" report, there were 604,127 new cases of cervical cancer in women worldwide in 2020, with 341,831 deaths, ranking it as the fourth most common cancer among women. Cervical cancer incidence ranks second among malignant tumors in Chinese women. According to the "National Cancer Report 2024" released by the National Cancer Center, there were 150,700 new cases of cervical cancer in China in 2022, with 55,700 deaths from cervical cancer. The main cause of cervical cancer is persistent infection with human papillomavirus (HPV), which leads to precancerous lesions of the cervix. Approximately 25% of individuals with HSIL may progress to invasive cervical cancer within 10 years[3]. According to Frost Sullivan analysis, it is projected that by 2030, the number of HSIL patients worldwide and in China will reach 16.6 million and 2.2 million, respectively. With the increasing popularity of dual-cancer screening and cervical cytology tests, more and more patients with cervical precancerous lesions are being detected at early stages before cancer develops, and it is expected that the number of patients will continue to increase. Women with cervical precancerous lesions have unmet clinical needs for non-surgical therapies. Currently, invasive procedures such as loop electrosurgical excision procedure (LEEP) and cold knife conization remain the primary treatment options for high-grade cervical lesions. However, these surgical treatments are associated with adverse reactions including bleeding, infection, and cervical structural damage, which may lead to complications such as preterm birth and miscarriage. Furthermore, cervical precancerous lesions require long-term monitoring and management because even after surgical treatment, there is a risk of persistent disease or recurrence, with a higher risk of developing cervical cancer compared to the general population (5 times higher risk of invasive cancer within 10 years). Therefore, post-operative follow-up for at least 25 years is necessary. Importantly, if cervical precancerous lesions recur, subsequent surgical interventions become more challenging and carry higher risks, potentially resulting in total hysterectomy. Thus, early surgical intervention increases the difficulty of long-term management. Non-surgical therapies that preserve the intact cervix and avoid or delay cervical trauma are of significant importance for the long-term management of patients with cervical precancerous lesions. Professor Chen Fei, Chief Physician of the Department of Obstetrics and Gynecology at Peking Union Medical College Hospital, expressed her delight with the research findings, stating, "I am extremely pleased with the results of this study. Treating HSIL serves as the final barrier against cervical cancer. Previous international studies on HSIL have not been successful, but this study, utilizing a multicenter trial design and strict definition of efficacy endpoints, has achieved positive results, which is no easy feat. As a clinician, I have encountered many HSIL patients who desire to preserve their intact cervix while receiving treatment. The emergence of APL-1702 will fulfill the wishes of these patients, allowing them to avoid or delay cervical trauma to the maximum extent possible." Professor Qiao Youlin, a member of the WHO Global Expert Group for Cervical Cancer Elimination and a professor at the School of Population Medicine and Public Health at the Chinese Academy of Medical Sciences/Peking Union Medical College, believes that in addition to vaccination and screening, treatment of cervical precancerous lesions is a crucial component of secondary prevention for cervical cancer. However, progress in the field of medication for cervical precancerous lesions has been relatively slow, with high barriers to overcome, and there are currently no approved treatment drugs worldwide. "It is gratifying to see the emergence of innovative products like APL-1702, which simultaneously possess clinical value in addressing the treatment gap, public health value in cervical cancer prevention and control, and social value in promoting fertility-friendly options. This breakthrough will safeguard women's health and make a positive contribution to the acceleration of the 2030 global and Chinese action plans for cervical cancer elimination". Dr. Linda Wu, Chief Development Officer of Asieris Pharmaceuticals, said, "We are extremely proud of the results from the international multicenter Phase III clinical study of APL-1702. The study not only demonstrates remarkable efficacy but also exhibits a favorable safety profile, offering a new powerful artillery for the national cervical cancer prevention and control system. We express our gratitude to all the patients, physicians, and researchers who participated in this study, as their support and dedication have been invaluable. We are actively preparing the new drug application for APL-1702 and plan to submit it in the second quarter of this year. Additionally, we are making significant progress in product development overseas, aiming to bring this innovative treatment to more patients as soon as possible." References ： EUROGIN: Photodynamic therapy with APL-1702 for high-grade squamous intraepithelial lesions (HSIL): results from a randomized phase Ⅲ global study (YHGT-CEV-1/APRICITY) SGO: APL-1702 long-term efficacy and safety for cervical histologic high-grade squamous intraepithelial lesions (HSIL): results from a randomized phase Ⅲ global study Gao Shujun, Sui Long. Standardized management and follow-up of high-grade squamous intraepithelial lesions of the cervix[J]. Chinese Journal of Practical Gynecology and Obstetrics. 2020,36(07):604-608. About APL-1702(Cevira ® ) APL-1702(Cevira ®) is a breakthrough photodynamic drug-device combination product that is being developed for non-surgical treatment of high-grade precancerous lesions of the cervix. Cevira ® holds the potential to serve the high unmet medical need for non-invasive treatment options for patients with HSIL in an outpatient setting, especially for young women of reproductive age. Asieris Pharmaceuticals entered into a license agreement with Photocure ASA (Photocure, PHO: OSE) to obtain the worldwide development and commercialization of Cevira ® in July 2019. Cevira ® is a registered trademark of Photocure ASA, based in Oslo, Norway. About Asieris Asieris Pharmaceuticals(688176.SH), founded in March 2010, is a global biopharma company specializing in discovering, developing and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases. We strive to improve human health to preserve patient's dignity. We aim to become a global pharma leader that integrates R&D, manufacturing and commercialization in our areas of focus, as we provide best-in-class integrated diagnosis and treatment solutions for patients in China and worldwide. The company has been developing its proprietary R&D platform and core technologies, exploring new mechanisms of action, and efficiently screening and evaluating drug candidates. With a well-established in-house R&D system and expertise in global drug development, Asieris is committed to launching first-in-class drugs and other innovative products to address huge unmet needs in its areas of focus. Asieris is also enhancing its pipeline for genitourinary diseases via proprietary R&D and strategic partnerships, while closely following cutting-edge technologies and therapeutics. The company strives to discover and identify unmet clinical needs, and adopts a forward-looking approach in product planning and life-cycle management. We aim to establish an outstanding portfolio that covers diagnosis and treatment in a bid to benefit more patients in China and globally. SOURCE Asieris

Potential vadadustat U.S. approval on PDUFA date of March 27, 2024 Strengthened balance sheet with $55.0 million term loan financing and $26.0 million in proceeds from ATM Reported 2023 Auryxia (ferric citrate) net product revenue of $170.3 million CAMBRIDGE, Mass., March 14, 2024 /PRNewswire/ -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today reported financial results for the fourth quarter and full year ended December 31, 2023 and recent business highlights. Akebia is preparing for a potential launch of vadadustat, which is currently under review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) date of March 27, 2024. "We are eagerly awaiting the PDUFA date for vadadustat, now within weeks, and we believe the progress we have made over the past 12 months has positioned our team to successfully launch vadadustat in the U.S., if approved," said John P. Butler, Chief Executive Officer of Akebia. "A U.S. approval for vadadustat will be transformational for Akebia and a significant step toward our goal of bettering the lives of people impacted by kidney disease. Our team remains dedicated to delivering an innovative oral therapeutic treatment for anemia due to chronic kidney disease for patients on dialysis." Fourth Quarter 2023 and Recent Business Highlights: Appointed Nicholas Grund as Chief Commercial Officer, who brings years of expertise in customer-facing roles to Akebia. Mr. Grund's operational, commercial and strategic leadership experience across renal and specialty markets will be critical as Akebia prepares for the vadadustat launch in the U.S., if approved. Introduced new pipeline programs in acute care settings, potentially for acute kidney injury or acute respiratory distress syndrome (AKB-9090) and retinopathy of prematurity in neonates (AKB-10108). Closed a new debt facility with BlackRock that provides access to up to $55.0 million in borrowing capacity and used the proceeds from the first tranche of $37.0 million to pay down principal outstanding under the then loan agreement with Pharmakon Advisors, LP. The BlackRock debt facility, which closed on January 29, 2024, also extends the interest-only period in the event of vadadustat approval in the U.S. on or prior to June 30, 2024 without requiring any principal repayment until December 31, 2026. Concluded its offering of common stock under its "at-the-market" (ATM) sales agreement. Akebia raised approximately $26.0 million in gross proceeds. Akebia reported fourth quarter 2023 Auryxia® (ferric citrate) net product revenues of $53.2 million and full year 2023 revenues of $170.3 million, within Akebia's 2023 Auryxia net product revenue guidance of $170.0 - $175.0 million. "We are approaching a potential U.S. launch of vadadustat from an extremely strong financial position. We expect Auryxia net product revenue growth in 2024, with a quarterly revenue cadence that is similar to 2023, we executed a term loan with BlackRock and implemented other financial strategies that together we believe will support our business operations for at least two years if vadadustat is approved. As we move forward, we will continue to carefully manage expenses, while investing appropriately for a successful potential launch of vadadustat," Mr. Butler added. Financial Results Revenues: Total revenues were $56.2 million for the fourth quarter of 2023 compared to $55.8 million for the fourth quarter of 2022, and $194.6 million for the full-year 2023 compared to $292.5 million for the full-year 2022. Net product revenues were $53.2 million for the fourth quarter of 2023 compared to $50.3 million for the fourth quarter of 2022, and $170.3 million for the full-year 2023 compared to $176.9 million for the full-year 2022. License, collaboration and other revenues were $3.0 million for the fourth quarter of 2023 compared to $5.5 million for the fourth quarter of 2022, and $24.3 million for the full-year 2023 compared to $115.5 million for the full-year 2022. COGS: Cost of goods sold was $18.7 million for the fourth quarter of 2023 compared to a benefit of $3.4 million for the fourth quarter of 2022, and $74.1 million for the full-year 2023 compared to $85.6 million for the full-year 2022. Akebia continues to record a non-cash intangible amortization charge of $9.0 million per quarter through the fourth quarter of 2024. R&D Expenses: Research and development expenses were $9.9 million for the fourth quarter of 2023 compared to $32.1 million for the fourth quarter of 2022, and $63.1 million for the full-year 2023 compared to $130.0 million for the full-year 2022. SG&A Expenses: Selling, general and administrative expenses were $25.4 million for the fourth quarter of 2023 compared to $29.9 million for the fourth quarter of 2022, and $100.2 million for the full-year 2023 compared to $138.6 million for the full-year 2022. Net Income / Loss: Net income was $0.6 million for the fourth quarter of 2023 compared to a net loss of $6.1 million for the fourth quarter of 2022, and $51.9 million for the full-year 2023 compared to $94.2 million for the full-year 2022. Cash Position: Cash and cash equivalents as of December 31, 2023, were approximately $42.9 million. Akebia believes its existing cash resources and the cash it expects to generate from product, royalty, supply and license revenues as well as the borrowings and potential future borrowings that are available under the BlackRock debt facility and the working capital liability are sufficient to fund our current operating plan for at least twenty-four months if vadadustat is approved. About Akebia Therapeutics Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease. Akebia was founded in 2007 and is headquartered in Cambridge, Massachusetts. For more information, please visit our website at , which does not form a part of this release. About Vadadustat Vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor designed to mimic the physiologic effect of altitude on oxygen availability. At higher altitudes, the body responds to lower oxygen availability with stabilization of hypoxia-inducible factor, which can lead to increased red blood cell production and improved oxygen delivery to tissues. Vadadustat is not approved by the U.S. Food and Drug Administration. Vadadustat is approved in Europe and Australia for the treatment of symptomatic anemia due to CKD in adult patients on chronic maintenance dialysis and in Taiwan for the treatment of anemia due to CKD in adult patients on dialysis. In Japan, vadadustat is approved as a treatment for anemia due to CKD in both dialysis-dependent and non-dialysis dependent adult patients. IMPORTANT SAFETY INFORMATION FOR VAFSEO (vadadustat) For safety information, view the European Summary of Product Characteristics (SPC/SmPC) for Vafseo® (vadadustat) at , and and will be available via the Australian Therapeutic Goods Administration website. IMPORTANT U.S. SAFETY INFORMATION FOR AURYXIA (ferric citrate) CONTRAINDICATION AURYXIA (ferric citrate) is contraindicated in patients with iron overload syndromes, e.g., hemochromatosis. WARNINGS AND PRECAUTIONS Iron Overload: Increases in serum ferritin and transferrin saturation (TSAT) were observed in clinical trials with AURYXIA in patients with chronic kidney disease (CKD) on dialysis treated for hyperphosphatemia, which may lead to excessive elevations in iron stores. Assess iron parameters prior to initiating AURYXIA and monitor while on therapy. Patients receiving concomitant intravenous (IV) iron may require a reduction in dose or discontinuation of IV iron therapy. Risk of Overdosage in Children Due to Accidental Ingestion: Accidental ingestion and resulting overdose of iron-containing products is a leading cause of fatal poisoning in children under 6 years of age. Advise patients of the risks to children and to keep AURYXIA out of the reach of children. ADVERSE REACTIONS Most common adverse reactions with AURYXIA were: Hyperphosphatemia in CKD on Dialysis: Diarrhea (21%), discolored feces (19%), nausea (11%), constipation (8%), vomiting (7%) and cough (6%). Iron Deficiency Anemia in CKD Not on Dialysis: Discolored feces (22%), diarrhea (21%), constipation (18%), nausea (10%), abdominal pain (5%) and hyperkalemia (5%). SPECIFIC POPULATIONS Pregnancy and Lactation: There are no available data on AURYXIA use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. However, an overdose of iron in pregnant women may carry a risk for spontaneous abortion, gestational diabetes and fetal malformation. Data from rat studies have shown the transfer of iron into milk, hence, there is a possibility of infant exposure when AURYXIA is administered to a nursing woman. To report suspected adverse reactions, contact Akebia Therapeutics at 1-844-445-3799. Please see full Prescribing Information Forward-Looking Statements Statements in this press release regarding Akebia Therapeutics, Inc.'s ("Akebia's") strategy, plans, prospects, expectations, beliefs, intentions and goals are forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended, and include, but are not limited to, statements regarding: Akebia's financial results for the fourth quarter and full year ended December 31, 2023; the anticipated scheduled PDUFA date for vadadustat and the potential approval of vadadustat; Akebia's ability to enable a successful commercial launch of vadadustat, if approved; statements that a U.S. approval for vadadustat will be transformational for Akebia; Akebia's expectations and beliefs regarding the impact that the BlackRock debt facility will have on Akebia; Akebia's expectations for Auryxia revenue growth in 2024 and assumptions related thereto; Akebia's plans with respect to vadadustat as a treatment of anemia due to chronic kidney disease in patients on dialysis in the U.S.; Akebia's expectations with respect to Akebia's pipeline in acute care settings for acute kidney injury or acute respiratory distress syndrome (AKB-9090) and retinopathy of prematurity in neonates (AKB-10108) and market potential; and Akebia's goals, objectives and expectations with respect to its operating plan, expenses, cash resources and sources of funding for its cash runway, including its belief that its existing cash resources and the cash it expects to generate from product, royalty, supply and license revenues as well as the borrowings and potential future borrowings that are available under the BlackRock debt facility and the working capital liability are sufficient to fund our current operating plan for at least twenty-four months if vadadustat is approved. The terms "intend," "believe," "plan," "goal," "potential," "anticipate, "estimate," "expect," "future," "will," "continue," derivatives of these words, and similar references are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results, performance or experience may differ materially from those expressed or implied by any forward-looking statement as a result of various risks, uncertainties and other factors, including, but not limited to, risks associated with: the potential demand and market potential and acceptance of, as well as coverage and reimbursement related to, Auryxia, including estimates regarding the potential market opportunity; the competitive landscape for Auryxia, including potential generic entrants; the ability of Akebia to attract and retain qualified personnel; Akebia's ability to implement cost avoidance measures and reduce operating expenses; decisions made by health authorities, such as the FDA, with respect to regulatory filings, including the anticipated FDA decision on the NDA for vadadustat and the potential effects of a negative decision on Akebia's cash runway; the potential therapeutic benefits, safety profile, and effectiveness of vadadustat; the results of preclinical and clinical research; the direct or indirect impact of the COVID-19 pandemic on regulators and Akebia's business, operations, and the markets and communities in which Akebia and its partners, collaborators, vendors and customers operate; manufacturing, supply chain and quality matters and any recalls, write-downs, impairments or other related consequences or potential consequences; and early termination of any of Akebia's collaborations. Other risks and uncertainties include those identified under the heading "Risk Factors" in Akebia's Quarterly Report on Form 10-Q for the quarter ended September 30, 2023, and other filings that Akebia may make with the U.S. Securities and Exchange Commission in the future. These forward-looking statements (except as otherwise noted) speak only as of the date of this press release, and, except as required by law, Akebia does not undertake, and specifically disclaims, any obligation to update any forward-looking statements contained in this press release. Akebia Therapeutics®, Auryxia® and Vafseo® are registered trademarks of Akebia Therapeutics, Inc. and its affiliates. Akebia Therapeutics Contact Mercedes Carrasco [email protected] SOURCE Akebia Therapeutics, Inc.

Bionano will host a pre-conference scientific session that will include a live product demonstration of the Stratys™ system for high throughput optical genome mapping (OGM) and findings from early access customersThe pre-conference event will also include a 2024 corporate overview from Bionano’s chief executive officer, Dr. Erik Holmlin, presentations from Dr. Brynn Levy at Columbia University Medical Center, Dr. Ulrich Broeckel at Medical College of Wisconsin, Dr. Susan Crocker at Kingston Health Sciences Centre, Dr. Liz McCready at Hamilton Health Science Center, and Dr. Zeid Hamadeh at Vancouver General Hospital covering the utility of OGM and VIA™ software and the adoption, implementation, and advanced research capabilities of the Stratys system, and will conclude with a fireside chat with panelists hosted by Bionano’s chief medical officer, Dr. Alka ChaubeyIn a sponsored session, Dr. Chaubey will cover findings from large multi-site clinical studies using OGM as well as features of the Stratys system. Dr. Tara Spence from Vancouver General Hospital will present insights into her laboratory’s adoption of Stratys and its potential impact on hematological malignancy analysis A scientific platform presentation will feature Drs. Hamadeh and Spence discussing OGM’s utility for the genotyping of hematological neoplasmsDr. Holmlin will participate with Dr. Nancy Mendelsohn, president of the ACMG Foundation, in the foundation’s educational and clinical laboratory genetics and genomics (LGG) awards ceremony by presenting the fellowship awards sponsored by BionanoEleven scientific posters featuring results from OGM applications in cancer, postnatal applications and genetic disorders will be presented at the conference SAN DIEGO, March 07, 2024 (GLOBE NEWSWIRE) -- Bionano Genomics, Inc. (Nasdaq: BNGO) today announced its participation in the American College of Medical Genetics and Genomics (ACMG) Annual Clinical Genetics Meeting 2024 with a broad range of content covering optical genome mapping’s (OGM) utility for research areas including cancer, rare genetic disease and constitutional disorders. ACMG’s Annual Meeting brings together industry, medical, and academic professionals to discuss advances in clinical genetics research. The ACMG conference will be held March 12-16, 2024, in Toronto, Canada. All scientific posters will be presented in Exhibit Halls DE. Poster presentations and scientific workshop sessions on OGM include: Poster Number Title AuthorsPresentedP573 Genome-wide short tandem repeat expansion screening using optical genome mapping Yu J.March 14, 202410:30 AM-12:00 PM ETP583 Clinical utility of optical genome mapping as an additional test to standard cytogenetic workup of hematological malignancies Toruner G.March 14, 202410:30 AM- 12:00 PM ETP839 A curated research catalogue of structural variation detected by optical genome mapping Pang A.March 14, 202410:30 AM-12:00 PM ETP088 A comprehensive approach to evaluate genetic abnormalities in plasma cell neoplasms using optical genome mapping and next-generation sequencing Zou Y.March 15, 202410:30 AM-12:00 PM ETP608 Optical genome mapping for genome-wide structural variation analysis in hematologic malignancies: results of a prospective study and potential impact on diagnosis and management Sahoo T.March 15, 202410:30 AM-12:00 PM ETP656 Improved diagnostic paradigm using optical genome mapping (OGM) for cytogenomic testing for recurrent pregnancy loss and infertility Crocker S.March 15, 202410:30 AM-12:00 PM ETP694 Case report: unraveling a complex chromosomal rearrangement case using optical genome mapping Ozcan Z.March 15, 202410:30 AM- 12:00 PM ETP742 Assessing stability of frozen samples for Bionano optical single DNA mapping for diagnosis of Facioscapulohumeral Muscular Dystrophy Type 1 Cook S.March 15, 202410:30 AM-12:00 PM ETP746 Genome wide, high-throughput, high-resolution structural variation detection at low variant allele fraction for oncology samples Hastie A.March 15, 202410:30 AM-12:00 PM ETP842 Unified comprehensive analysis of NGS and optical genome mapping data for constitutional applications using Bionano VIA™ software Norgaard Z.March 15, 202410:30 AM-12:00 PM ETP850 Accelerated optical genome mapping analysis with Stratys Compute and Guided Assembly Senol Cali D.March 15, 202410:30 AM-12:00 PM ETSession Title PresenterPresentedSponsored Workshop LIVE Bionano product showcase – Stratys™ revealed: exclusive first look at the future of OGM Chaubey A., Broeckel U., Crocker S., Hamadeh Z., Holmlin E., Jiandani D., Levy B., McCready L., Sahoo T.March 12, 20248:00 AM- 12:30 PM ETDelta Hotel by Marriott- Kensington BallroomPlenary Session 2024 ACMG Foundation Awards and Presidential Plenary Session Holmlin E.March 13, 202410:00-12:00 PM ETExhibit Hall FGPlatform Presentation A Canadian lab’s clinical validation experience with optical genome mapping as a front-line diagnostic test for hematological neoplasms Hamadeh Z., Spence T.March 14, 20244:15-5:45 PM ETMTCC- 714/716Sponsored Workshop Revolutionizing cytogenomics with Stratys™: unveiling a new frontier in structural variant assessment through optical genome mapping at scale Chaubey A., Spence T.,March 15, 202410:45-11:15 AM ETExhibit Theater 2 Erik Holmlin, PhD, president and chief executive officer of Bionano, added, “We are proud to debut our new high throughput system for OGM, Stratys, at ACMG this year, and to host sessions featuring customers from our Stratys early access program presenting data from work conducted on the system. Researchers and scientists continue to push forward cutting-edge research in the human genetics space and we believe the capabilities of the Stratys system will unlock even more exciting research advancements. We look forward to these customers sharing their findings with the ACMG community.” More details on Bionano’s conference events can be found here. 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. Bionano’s mission is to transform the way the world sees the genome through OGM solutions, diagnostic services and software. Bionano offers OGM solutions for applications across basic, translational and clinical research. Through its Lineagen, Inc. d/b/a Bionano Laboratories business, Bionano also provides diagnostic testing for patients with clinical presentations consistent with autism spectrum disorder and other neurodevelopmental disabilities. Bionano 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. Bionano additionally offers nucleic acid extraction and purification solutions using proprietary isotachophoresis technology. 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,” “potential,” “will,” 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: OGM’s utility for applications in cancer, rare genetic disease and constitutional disorder research and in the areas reported in the presentations given and the posters made available at ACMG’s 2024 Annual Meeting; the ability of the Stratys system to unlock research advancements; and the growth and adoption of OGM. 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 adverse geopolitical and macroeconomic events, such as the ongoing conflicts between Ukraine and Russia and Israel and Gaza and uncertain market conditions, including bank failures, inflation and supply chain disruptions, on our business and the global economy; general market conditions; changes in the competitive landscape and the introduction of competitive technologies or improvements to existing technologies; failure of OGM to prove useful in areas including applications in cancer, rare genetic disease and constitutional disorder research and in the areas reported in the presentations given and the posters made available at ACMG’s Annual Meeting; failure of the Stratys system to unlock research advancements; failure of laboratories to adopt OGM; the ability of our OGM solutions to offer the anticipated benefits for and contributions to the areas reported in the presentations given and posters made available at the ACMG’s 2024 Annual Meeting; future study results contradicting the results reported in the presentations given and posters made available at the ACMG’s 2024 Annual Meeting; changes in our strategic and commercial plans; our ability to obtain sufficient financing to fund our strategic plans and commercialization efforts; 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. CONTACTSCompany Contact:Erik Holmlin, CEOBionano Genomics, Inc.+1 (858) 888-7610eholmlin@bionano.com Investor Relations:David HolmesGilmartin Group+1 (858) 888-7625IR@bionano.com