Common use of PROSPECTUS SUMMARY Clause in Contracts

PROSPECTUS SUMMARY. This summary highlights selected information that is presented in greater detail elsewhere, or incorporated by reference, in this prospectus. It does not contain all of the information that may be important to you and your investment decision. Before investing in our securities, you should carefully read this entire prospectus, including the matters set forth under the section of this prospectus captioned “Risk Factors” and the financial statements and related notes and other information that we incorporate by reference herein, including our Annual Report on Form 10-K and our Quarterly Reports on Form 10-Q. Unless the context indicates otherwise, references in this prospectus to “Edgewise Therapeutics, Inc.,” “Edgewise,” “we,” “our” and “us” refer, collectively, to Edgewise Therapeutics, Inc., a Delaware corporation. Company Overview At Edgewise, patients are at the core of everything we do. We recognize that for patients with rare and debilitating diseases, every day without an effective treatment is a day too late and we are driven by this urgency to evolve disease knowledge with an aim to develop novel precision medicines for severe and rare disorders driven by muscle dysfunction. Our intimate knowledge of muscle biology and biophysics along with our ability to identify and design muscle specific precision small molecules have enabled us to rapidly advance our lead product candidate into clinical development while advancing our preclinical pipeline. From this foundation, we continue to build a leading, global biopharmaceutical company focused on rare diseases involving muscle in order to develop transformative precision medicines to treat and possibly cure these disorders. In less than five years, we have matured into a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of innovative treatments for severe, rare muscle disorders for which there is significant unmet medical need. Guided by our holistic drug discovery approach to targeting the muscle as an organ, we have combined our foundational expertise in muscle biology and small molecule engineering to build our proprietary, muscle-focused drug discovery platform. Our platform utilizes custom-built high throughput and translatable systems that measure integrated muscle function in whole organ extracts to identify small molecule precision medicines regulating key proteins in muscle tissue, initially focused on addressing rare neuromuscular and cardiac diseases. Since our inception in 2017, our precision medicine muscle platform has generated several programs to address a variety of muscle disorders. We are advancing one clinical-stage program and two preclinical programs. Our lead product candidate, EDG-5506, is an orally administered allosteric, selective, fast myofiber (type II) myosin small molecule inhibitor designed to address the root cause of dystrophinopathies including Duchenne muscular dystrophy (DMD) and Xxxxxx muscular dystrophy (BMD). Both of these disorders are rare and often debilitating diseases, and we estimate that in the United States there are approximately 12,000 to 15,000 DMD patients and 4,000 to 5,000 BMD patients. As a selective fast myosin inhibitor, EDG-5506 presents a novel mechanism of action designed to selectively limit injurious stress caused by lack of dystrophin by moderating fast skeletal muscle myosin force development and thereby compensating for the absence of functional dystrophin. Our preclinical data with EDG-5506 in animal models of muscular dystrophy demonstrated that selective regulation of fast (type II) myofiber contraction protected muscle from damage, reduced systemic fibrosis and improved measures of muscle function including strength and ability to engage in physical activities, which we believe may provide evidence of a disease modifying effect. A unique observation from our preclinical work is that EDG-5506 led to pronounced prevention of cardiac fibrosis. This is a highly relevant finding, particularly if replicated in clinical observations, since cardiac myopathy is a major driver of mortality in both DMD and BMD. EDG-5506 was evaluated in a Phase 1 clinical trial designed to assess the safety, tolerability and pharmacokinetics (PK) of EDG-5506 in adult healthy volunteers (HVs) (Phase 1a) and in adults with BMD (Phase 1b). Our Phase 1a data in HVs demonstrated that EDG-5506 was generally well-tolerated and amenable to daily dosing. Our Phase 1b data in BMD patients demonstrated proof of concept by showing a significant reduction in key biomarkers of muscle damage. We believe EDG-5506 has potential therapeutic utility as either a standalone or combination therapy for patients suffering from rare muscular dystrophies, if approved. We also intend to develop two other muscle-focused precision medicines. Our second program, EDG-5440, is a next generation myosin ATPase modulator designed to target skeletal muscle in a specific set of rare neuromuscular diseases. Our third program, EDG-002, focuses on identification of novel mechanism cardiac modulators. We are initially pursuing a new target for inherited hypertrophic cardiomyopathy (HCM) in addition to exploring the potential of this novel mechanism across other cardiac disorders. Our preliminary preclinical studies offer evidence that our EDG-002 program has the potential to yield molecules that could become a new therapeutic option for the treatment of HCM as well as other cardiac disorders. We anticipate candidate selection of a novel cardiac modulator for inherited hypertrophic cardiomyopathy from our EDG-002 cardiac muscle program in the second half of 2022. We believe our programs also offer substantial opportunities for us to expand into related rare diseases for which there are limited or no approved treatments. We are currently focusing on the development of EDG-5506 and anticipate advancing our preclinical programs into the next stage of development in the near term. While EDG-5440 and EDG-002 are important preclinical programs to us, we have not needed to devote significant financial resources to these programs to date since they are still in preclinical development and have not yet advanced into clinical trials. Corporate Information We were incorporated in Delaware in May 2017. Our principal executive offices are located at 0000 Xxxxxxxx Xxx., Xxxxxxx, Xxxxxxxx 00000. Our telephone number is 000-000-0000. Our website address is xxx.xxxxxxxxxx.xxx. Information contained on, or that can be accessed through, our website or any website is not incorporated by reference into this prospectus and should not be considered to be part of this prospectus unless expressly noted. We may use our website (xxx.xxxxxxxxxx.xxx), press releases, public conference calls, public webcasts, Twitter and LinkedIn as means of disclosing material non-public information and for complying with our disclosure obligations under Regulation FD. We also make available on or through our website certain reports and amendments to those reports that we file with or furnish to the SEC in accordance with the Securities Exchange Act of 1934, as amended (Exchange Act). These include our Annual Reports on Form 10-K, our quarterly reports on Form 10-Q, and our current reports on Form 8- K, and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act. We make this information available on or through our website free of charge as soon as reasonably practicable after we electronically file the information with, or furnish it to, the SEC. The SEC also maintains a website that contains our SEC filings. The address for the SEC website is xxx.xxx.xxx. We use the Edgewise Therapeutics logo and other marks as trademarks in the United States and other countries. This prospectus contains references to our trademarks and service marks and to those belonging to other entities. Solely for convenience, trademarks and trade names referred to in this prospectus, including logos, artwork and other visual displays, may appear without the TM symbol, but such references are not intended to indicate in any way that we will not assert, to the fullest extent under applicable law, our rights or the rights of the applicable licensor to these trademarks and trade names. We do not intend our use or display of other entities’ trade names, trademarks or service marks to imply a relationship with, or endorsement or sponsorship of us by, any other entity. The Securities That May Be Offered We may offer or sell common stock, preferred stock, depositary shares, debt securities, warrants, subscription rights, purchase contracts and units in one or more offerings and in any combination. The aggregate offering price of the securities we sell pursuant to this prospectus will not exceed $400,000,000. Each time securities are offered with this prospectus, we will provide a prospectus supplement that will describe the specific amounts, prices and terms of the securities being offered and the net proceeds we expect to receive from that sale. The securities may be sold to or through underwriters, dealers or agents or directly to purchasers or as otherwise set forth in the section of this prospectus captioned “Plan of Distribution.” Each prospectus supplement will set forth the names of any underwriters, dealers, agents or other entities involved in the sale of securities described in that prospectus supplement and any applicable fee, commission or discount arrangements with them. Common Stock We may offer shares of our common stock, par value $0.0001 per share, either alone or underlying other registered securities convertible into our common stock. Holders of our common stock are entitled to receive dividends declared by our board of directors out of funds legally available for the payment of dividends, subject to rights, if any, of preferred stockholders. We have not paid dividends in the past and have no current plans to pay dividends. Each holder of common stock is entitled to one vote per share. The holders of common stock have no preemptive rights.

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Samples: Prospectus Supplement

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PROSPECTUS SUMMARY. This summary highlights selected information that is presented contained elsewhere in greater detail elsewhere, this prospectus or incorporated by reference, reference in this prospectus. It , and does not contain all of the information that may be important you need to you and consider in making your investment decision. Before investing in our securities, you You should carefully read this the entire prospectus and any related free writing prospectus, including the matters set forth risks of investing in our securities discussed under the section of this prospectus captioned titled “Risk Factors” contained in this prospectus and any related free writing prospectus, and under similar headings in the financial statements and related notes and other information documents that we incorporate are incorporated by reference hereininto this prospectus. You should also carefully read the information incorporated by reference into this prospectus, including our Annual Report on Form 10-K financial statements, and our Quarterly Reports on Form 10-Q. the exhibits to the registration statement of which this prospectus is a part. Unless the context indicates otherwiseotherwise requires, references in this prospectus to we use the terms Edgewise Therapeutics, Inc.Immunovant,” “Edgewisecompany,” “we,” “ourus” and “usourreferin this prospectus to refer to Immunovant, collectively, to Edgewise Therapeutics, Inc., a Delaware corporation. Company Overview At Edgewise, patients are at the core of everything we do. We recognize that for patients with rare Inc. and debilitating diseases, every day without an effective treatment is a day too late and we are driven by this urgency to evolve disease knowledge with an aim to develop novel precision medicines for severe and rare disorders driven by muscle dysfunctionour wholly owned subsidiaries. Our intimate knowledge of muscle biology and biophysics along with our ability to identify and design muscle specific precision small molecules have enabled us to rapidly advance our lead product candidate into clinical development while advancing our preclinical pipelinefiscal year ends on March 31. From this foundationImmunovant, we continue to build a leading, global biopharmaceutical company focused on rare diseases involving muscle in order to develop transformative precision medicines to treat and possibly cure these disorders. In less than five years, we have matured into Inc. Overview We are a clinical-stage biopharmaceutical company focused on enabling normal lives for patients with autoimmune diseases. We are developing a novel, fully human monoclonal antibody, IMVT-1401 (formerly referred to as RVT-1401), that selectively binds to and inhibits the discoveryneonatal fragment crystallizable receptor, or FcRn. IMVT-1401 is the product of a multistep, multi-year research program conducted by HanAll Biopharma Co., Ltd., or HanAll, to design a highly potent anti-FcRn antibody optimized for subcutaneous delivery. These efforts have resulted in a product candidate that has been dosed in small volumes (e.g. 2 mL) and with a 27-gauge needle, while still generating therapeutically relevant pharmacodynamic activity, important attributes that we believe will drive patient preference and market adoption. In nonclinical studies and in clinical trials conducted to date, IMVT-1401 has been observed to reduce immunoglobulin G, or IgG, antibody levels. High levels of pathogenic IgG antibodies drive a variety of autoimmune diseases and, as a result, we believe IMVT-1401 has the potential for broad application in these disease areas. We intend to develop IMVT-1401 in autoimmune diseases for which there is robust evidence that pathogenic IgG antibodies drive disease manifestation and for which reduction of IgG antibodies should lead to clinical benefit. We are developing IMVT-1401 as a fixed-dose, self-administered subcutaneous injection on a convenient weekly, or less frequent, dosing schedule. As a result of our rational design, we believe that IMVT-1401, if developed and approved for commercial sale, would be differentiated from currently available, more invasive treatments for advanced IgG-mediated autoimmune diseases (e.g., myasthenia gravis, or MG, thyroid eye disease, or XXX (formerly referred to as Xxxxxx’ ophthalmopathy, or GO), Warm Autoimmune Hemolytic Anemia, or WAIHA, idiopathic thrombocytopenic purpura, pemphigus vulgaris, chronic inflammatory demyelinating polyneuropathy, bullous pemphigoid, neuromyelitis optica, pemphigus foliaceus, Guillain-Barré syndrome and PLA2R+ membranous nephropathy). In 2019, these diseases had an aggregate prevalence of approximately 243,000 patients in the United States and 388,000 patients in Europe. To the extent we choose to develop IMVT-1401 for certain of these rare diseases, we plan to seek orphan drug designation in the United States and Europe. Such designations would primarily provide financial and exclusivity incentives intended to make the development of orphan drugs financially viable. However, we have not yet sought such designation for any of our three target indications, and there is no certainty that it would obtain such designation, or maintain the benefits associated with such designation, if or when we do. Risks Associated with our Business Our business is subject to numerous risks and uncertainties, including those highlighted in the section titled “Risk Factors” immediately following this prospectus summary and those incorporated by reference in this prospectus. These risks include, among others, the following: • Our business, operations and clinical development plans and timelines and supply chain could be adversely affected by the effects of health epidemics, including the ongoing COVID-19 pandemic, on the manufacturing, clinical trial and other business activities performed by us or by third parties with whom we conduct business, including our contract manufacturers, contract research organizations, or CROs, shippers and others. • We have a limited operating history and have never generated any product revenue. • We expect to incur significant losses for the foreseeable future and may never achieve or maintain profitability. • Our business is heavily dependent on the successful development, regulatory approval and commercialization of our sole product candidate, IMVT- 1401. • We will require additional capital to fund our operations, and if we fail to obtain necessary financing, we may not be able to complete the development and commercialization of innovative treatments for severeIMVT-1401. • Raising additional funds by issuing securities may cause dilution to existing stockholders, rare muscle disorders for raising additional funds through debt financings may involve restrictive covenants, and raising funds through lending and licensing arrangements may restrict our operations or require us to relinquish proprietary rights. • We rely on the license agreement with HanAll Biopharma Co., Ltd., or the HanAll Agreement, to provide rights to the core intellectual property relating to IMVT-1401. Any termination or loss of significant rights under the HanAll Agreement would adversely affect our development or commercialization of IMVT-1401. • The HanAll Agreement obligates us to make certain milestone payments, some of which there is significant unmet medical needmay be triggered prior to our potential commercialization of IMVT-1401. Guided by • We may not be able to manage our holistic drug discovery approach business effectively if we are unable to targeting the muscle as an organ, we have combined attract and retain key personnel. • We will need to expand our foundational expertise in muscle biology and small molecule engineering to build our proprietary, muscle-focused drug discovery platform. Our platform utilizes custom-built high throughput and translatable systems that measure integrated muscle function in whole organ extracts to identify small molecule precision medicines regulating key proteins in muscle tissue, initially focused on addressing rare neuromuscular and cardiac diseases. Since our inception in 2017, our precision medicine muscle platform has generated several programs to address a variety of muscle disorders. We are advancing one clinical-stage program and two preclinical programs. Our lead product candidate, EDG-5506, is an orally administered allosteric, selective, fast myofiber (type II) myosin small molecule inhibitor designed to address the root cause of dystrophinopathies including Duchenne muscular dystrophy (DMD) and Xxxxxx muscular dystrophy (BMD). Both of these disorders are rare and often debilitating diseasesorganization, and we estimate that may experience difficulties in the United States there are approximately 12,000 to 15,000 DMD patients and 4,000 to 5,000 BMD patients. As a selective fast myosin inhibitor, EDG-5506 presents a novel mechanism of action designed to selectively limit injurious stress caused by lack of dystrophin by moderating fast skeletal muscle myosin force development and thereby compensating for the absence of functional dystrophin. Our preclinical data with EDG-5506 in animal models of muscular dystrophy demonstrated that selective regulation of fast (type II) myofiber contraction protected muscle from damage, reduced systemic fibrosis and improved measures of muscle function including strength and ability to engage in physical activitiesmanaging this growth, which could disrupt our operations. If we believe are unable to adequately address these and other risks we face, our business, financial condition, operating results and prospects may provide evidence of a disease modifying effect. A unique observation from our preclinical work is that EDG-5506 led to pronounced prevention of cardiac fibrosis. This is a highly relevant finding, particularly if replicated in clinical observations, since cardiac myopathy is a major driver of mortality in both DMD and BMD. EDG-5506 was evaluated in a Phase 1 clinical trial designed to assess the safety, tolerability and pharmacokinetics (PK) of EDG-5506 in adult healthy volunteers (HVs) (Phase 1a) and in adults with BMD (Phase 1b). Our Phase 1a data in HVs demonstrated that EDG-5506 was generally well-tolerated and amenable to daily dosing. Our Phase 1b data in BMD patients demonstrated proof of concept by showing a significant reduction in key biomarkers of muscle damage. We believe EDG-5506 has potential therapeutic utility as either a standalone or combination therapy for patients suffering from rare muscular dystrophies, if approved. We also intend to develop two other muscle-focused precision medicines. Our second program, EDG-5440, is a next generation myosin ATPase modulator designed to target skeletal muscle in a specific set of rare neuromuscular diseases. Our third program, EDG-002, focuses on identification of novel mechanism cardiac modulators. We are initially pursuing a new target for inherited hypertrophic cardiomyopathy (HCM) in addition to exploring the potential of this novel mechanism across other cardiac disorders. Our preliminary preclinical studies offer evidence that our EDG-002 program has the potential to yield molecules that could become a new therapeutic option for the treatment of HCM as well as other cardiac disorders. We anticipate candidate selection of a novel cardiac modulator for inherited hypertrophic cardiomyopathy from our EDG-002 cardiac muscle program in the second half of 2022. We believe our programs also offer substantial opportunities for us to expand into related rare diseases for which there are limited or no approved treatments. We are currently focusing on the development of EDG-5506 and anticipate advancing our preclinical programs into the next stage of development in the near term. While EDG-5440 and EDG-002 are important preclinical programs to us, we have not needed to devote significant financial resources to these programs to date since they are still in preclinical development and have not yet advanced into clinical trialsbe adversely affected. Corporate Information We were incorporated in Delaware in May 2017December 2018 as a blank check company under the name Health Sciences Acquisitions Corporation, or HSAC. On December 18, 2019, Immunovant Sciences Ltd., or ISL, and HSAC consummated the transactions contemplated under that certain share exchange agreement dated as of September 29, 2019 by and among HSAC, ISL, the stockholders of ISL and Roivant Sciences Ltd., following the approval at the special meeting of the stockholders of HSAC held on December 16, 2019, which we refer to as the Business Combination. In connection with the closing of the Business Combination, we changed our name from HSAC to Immunovant, Inc. Our principal executive offices are located at 0000 Xxxxxxxx Xxx.000 Xxxx 00xx Xxxxxx, XxxxxxxXxx Xxxx, Xxxxxxxx 00000. Our Xxx Xxxx 00000 and our telephone number is (000-) 000-0000. Our corporate website address is xxx.xxxxxxxxxx.xxx. Information contained on, on or that can be accessed through, accessible through our website or any website is not incorporated by reference into this prospectus and should not be considered to be a part of this prospectus, and the inclusion of our website address in this prospectus unless expressly notedis an inactive textual reference only. We may use our website (xxx.xxxxxxxxxx.xxx)have four wholly owned subsidiaries: Immunovant Sciences Ltd., press releasesa Bermuda exempted limited company, public conference callsImmunovant Sciences Holdings Limited, public webcastsa limited company organized under the laws of the United Kingdom, Twitter or the U.K., IMVT Corporation, a Delaware corporation, and LinkedIn as means Immunovant Sciences GmbH, or ISG, a company with limited liability formed under the laws of disclosing material non-public information and for complying with our disclosure obligations under Regulation FDSwitzerland. We also make available on or through conduct business operations at 0000 Xxxx Xxxxx Xxxxx, Xxxxx 000, Xxxxxx, Xxxxx Xxxxxxxx 00000. ISG maintains its headquarters at Xxxxxxxxxxxxxx 0, 0000 Xxxxx, Xxxxxxxxxxx. ISG holds our website certain reports and amendments to those reports that we file with or furnish to the SEC intellectual property rights in accordance with the Securities Exchange Act of 1934, as amended (Exchange Act)our product candidate. These include our Annual Reports on Form 10-K, our quarterly reports on Form 10-Q, “IMMUNOVANT” and our current reports on Form 8- Kother registered and common law trade names, trademarks and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act. We make this information available on or through service marks are our website free of charge as soon as reasonably practicable after we electronically file the information with, or furnish it to, the SEC. The SEC also maintains a website that contains our SEC filings. The address for the SEC website is xxx.xxx.xxx. We use the Edgewise Therapeutics logo and other marks as trademarks in the United States and other countriesproperty. This prospectus contains references to our additional trade names, trademarks and service marks and to those belonging to other entitiesof others, which are the property of their respective owners. Solely for convenience, trademarks and trade names referred to in this prospectus, including logos, artwork and other visual displays, prospectus may appear without the TM symbol, but such references are not intended to indicate in any way that we will not assert, to the fullest extent under applicable law, our rights ® or the rights of the applicable licensor to these trademarks and trade names™ symbols. We do not intend our use or display of other entities’ trade names, trademarks or service marks to imply a relationship with, or endorsement or sponsorship of THE OFFERING Common stock offered by us by, any other entity. The Securities That May Be Offered We may offer or sell common stock, preferred stock, depositary shares, debt securities, warrants, subscription rights, purchase contracts and units in one or more offerings and in any combination. The aggregate offering price of the securities we sell pursuant to this prospectus will not exceed $400,000,000. Each time securities are offered with this prospectus, we will provide a prospectus supplement that will describe the specific amounts, prices and terms of the securities being offered and the net proceeds we expect to receive from that sale. The securities may be sold to or through underwriters, dealers or agents or directly to purchasers or as otherwise set forth in the section of this prospectus captioned “Plan of Distribution.” Each prospectus supplement will set forth the names of any underwriters, dealers, agents or other entities involved in the sale of securities described in that prospectus supplement and any applicable fee, commission or discount arrangements with them. Common Stock We may offer shares Shares of our common stock, par value $0.0001 per share, either alone or underlying other registered securities convertible into with an aggregate sale price of up to $150,000,000. Common stock to be outstanding after this offering Up to 101,288,213 shares, assuming the sale of 3,397,508 shares of our common stockstock in this offering at a public offering price of $44.15 per share, which was the last reported sale price of our common stock on the Nasdaq Global Select Market on January 13, 2021. Holders The actual number of shares of common stock issued will vary based on the actual public offering prices per share in this offering, the actual number of shares sold in this offering and other terms of the offering determined at the time shares of our common stock are entitled sold pursuant to receive dividends declared by our board this prospectus. Manner of directors out offering “At the market” offering that may be made from time to time through or to SVB Leerink. See “Plan of funds legally available for Distribution” on page 11. Use of proceeds We intend to use the payment of dividends, subject to rightsnet proceeds from this offering, if any, to advance the development of preferred stockholdersour product candidate, IMVT-1401, and for working capital and general corporate purposes. We have not paid dividends may also use a portion of the net proceeds to in-license, acquire or invest in the past and complementary businesses or products; however, we have no current plans commitments or obligations to pay dividendsdo so. Each holder See “Use of Proceeds” on page 9. Risk factors Investment in our securities involves a high degree of risk. You should read the “Risk Factors,” beginning on page 5 of this prospectus and in the documents incorporated by reference into this prospectus for a discussion of factors to consider before deciding to purchase shares of our common stock is entitled to one vote per share. The holders of common stock have no preemptive rightsstock.

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Samples: www.immunovant.com

PROSPECTUS SUMMARY. This summary highlights selected information that is presented in greater detail elsewhere, or incorporated by reference, in from this prospectus. It prospectus and does not contain all of the information that may be important you need to you and consider in making your investment decision. Before investing in our securities, you You should carefully read this the entire prospectus, the applicable prospectus supplement and any related free writing prospectus, including the matters set forth risks of investing in our securities discussed under the section of this prospectus captioned heading “Risk Factors” contained in the applicable prospectus supplement and any related free writing prospectus, and under similar headings in the financial statements and related notes and other information documents that we incorporate are incorporated by reference hereininto this prospectus. You should also carefully read the information incorporated by reference into this prospectus, including our Annual Report on Form 10-K financial statements, and our Quarterly Reports on Form 10-Q. the exhibits to the registration statement of which this prospectus is a part. Unless the context indicates otherwise, references as used in this prospectus to prospectus, the terms Edgewise Therapeutics, Inc.Fulgent Genetics,” “EdgewiseFulgent,” “the Company,” “we,” “ourus” and “usourrefer, collectively, refer to Edgewise TherapeuticsFulgent Genetics, Inc., a Delaware corporation. Company Overview At EdgewiseAbout Fulgent Genetics, patients are at Inc. Fulgent is a growing technology company offering comprehensive genetic testing and providing physicians with clinically actionable diagnostic information they can use to improve the core quality of everything we dopatient care. We recognize have developed a proprietary technology platform that for patients with rare allows us to offer a broad and debilitating diseasesflexible test menu and continually expand and improve our proprietary genetic reference library, every day without an effective treatment is a day too late while maintaining accessible pricing, high accuracy and we are driven by this urgency to evolve disease knowledge with an aim to develop novel precision medicines for severe and rare disorders driven by muscle dysfunctioncompetitive turnaround times. Our intimate knowledge of muscle biology and biophysics along Combining next generation sequencing, or NGS, with our ability to identify and design muscle specific precision small molecules have enabled us to rapidly advance our lead product candidate into clinical development while advancing our preclinical pipeline. From this foundationtechnology platform, we continue perform full-gene sequencing with deletion/duplication analysis in single- gene tests; pre-established, multi-gene, disease-specific panels; and customized panels that can be tailored to build a leading, global biopharmaceutical company focused on rare diseases involving muscle in order to develop transformative precision medicines to treat and possibly cure these disorders. In less than five years, we have matured into a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of innovative treatments for severe, rare muscle disorders for which there is significant unmet medical need. Guided by our holistic drug discovery approach to targeting the muscle as an organ, we have combined our foundational expertise in muscle biology and small molecule engineering to build our proprietary, muscle-focused drug discovery platform. Our platform utilizes custom-built high throughput and translatable systems that measure integrated muscle function in whole organ extracts to identify small molecule precision medicines regulating key proteins in muscle tissue, initially focused on addressing rare neuromuscular and cardiac diseases. Since our inception in 2017, our precision medicine muscle platform has generated several programs to address a variety of muscle disorders. We are advancing one clinical-stage program and two preclinical programs. Our lead product candidate, EDG-5506, is an orally administered allosteric, selective, fast myofiber (type II) myosin small molecule inhibitor designed to address the root cause of dystrophinopathies including Duchenne muscular dystrophy (DMD) and Xxxxxx muscular dystrophy (BMD). Both of these disorders are rare and often debilitating diseases, and we estimate that in the United States there are approximately 12,000 to 15,000 DMD patients and 4,000 to 5,000 BMD patients. As a selective fast myosin inhibitor, EDG-5506 presents a novel mechanism of action designed to selectively limit injurious stress caused by lack of dystrophin by moderating fast skeletal muscle myosin force development and thereby compensating for the absence of functional dystrophin. Our preclinical data with EDG-5506 in animal models of muscular dystrophy demonstrated that selective regulation of fast (type II) myofiber contraction protected muscle from damage, reduced systemic fibrosis and improved measures of muscle function including strength and ability to engage in physical activities, which we believe may provide evidence of a disease modifying effect. A unique observation from our preclinical work is that EDG-5506 led to pronounced prevention of cardiac fibrosis. This is a highly relevant finding, particularly if replicated in clinical observations, since cardiac myopathy is a major driver of mortality in both DMD and BMD. EDG-5506 was evaluated in a Phase 1 clinical trial designed to assess the safety, tolerability and pharmacokinetics (PK) of EDG-5506 in adult healthy volunteers (HVs) (Phase 1a) and in adults with BMD (Phase 1b). Our Phase 1a data in HVs demonstrated that EDG-5506 was generally well-tolerated and amenable to daily dosing. Our Phase 1b data in BMD patients demonstrated proof of concept by showing a significant reduction in key biomarkers of muscle damage. We believe EDG-5506 has potential therapeutic utility as either a standalone or combination therapy for patients suffering from rare muscular dystrophies, if approved. We also intend to develop two other muscle-focused precision medicines. Our second program, EDG-5440, is a next generation myosin ATPase modulator designed to target skeletal muscle in a meet specific set of rare neuromuscular diseases. Our third program, EDG-002, focuses on identification of novel mechanism cardiac modulators. We are initially pursuing a new target for inherited hypertrophic cardiomyopathy (HCM) in addition to exploring the potential of this novel mechanism across other cardiac disorders. Our preliminary preclinical studies offer evidence that our EDG-002 program has the potential to yield molecules that could become a new therapeutic option for the treatment of HCM as well as other cardiac disorders. We anticipate candidate selection of a novel cardiac modulator for inherited hypertrophic cardiomyopathy from our EDG-002 cardiac muscle program in the second half of 2022customer needs. We believe our programs also offer substantial opportunities test menu offers more genes for testing than our competitors in today’s market, which enables us to expand into related rare diseases provide expansive options for which there are limited or no approved treatmentstest customization and clinically actionable results. We are currently focusing on the development After launching our first commercial genetic tests in 2013 and as of EDG-5506 and anticipate advancing our preclinical programs into the next stage of development in the near term. While EDG-5440 and EDG-002 are important preclinical programs to usAugust 2019, we have not needed expanded our test menu to devote include approximately 18,000 single-gene tests and more than 800 panels that collectively test for approximately 7,700 genetic conditions, including various cancers, cardiovascular diseases, neurological disorders and pediatric conditions. A cornerstone of our business is our ability to provide expansive options and flexibility for all clients’ unique genetic testing needs. Genetic testing offers the possibility of early identification of a disease or a genetic predisposition to a disease and enhanced disease treatment and prognosis. As a result, we believe widespread genetic testing could enable significant financial resources health improvements and healthcare cost reductions by providing patients and clinicians with more advanced knowledge and options for personal health management plans. Due to these programs and other potential benefits, genetic testing has experienced significant growth in recent years. If this growth trend continues, we believe genetic testing will become part of standard medical care. The knowledge of a person’s unique genetic makeup could then begin to date since they play a more important role in the practice of medicine. We believe this growth has been tempered in prior years, however, because many tests are still prohibitively expensive, are produced through inefficient processes and often do not result in preclinical development clinically actionable data. Through our technology platform, we have developed an offering that we believe addresses these industry challenges and have not yet advanced into clinical trials. Corporate Information We were incorporated provides a sustainable competitive advantage, both in Delaware today’s genetic testing market and as we seek to implement new diagnostic tools in May 2017the future. Our principal executive offices are located at 0000 Xxxxxxxx Xxx.technology platform, Xxxxxxxwhich integrates sophisticated data comparison and suppression algorithms, Xxxxxxxx 00000adaptive learning software, advanced genetic diagnostics tools and integrated laboratory processes, allows us to offer a test menu with expansive genetic coverage. Our telephone number is 000-000-0000We believe the comprehensive data output and high detection rates of our tests, both made possible by this expansive genetic coverage, provide physicians with information they can readily incorporate into treatment decisions for their patients, which we refer to as clinical actionability. Our website address is xxx.xxxxxxxxxx.xxx. Information contained on, or that can be accessed throughIn addition, our website or any website is not incorporated by reference into technology platform facilitates our ability to perform customized genetic tests using our expansive library of genes, and we believe this prospectus flexibility increases the utility of the genetic data we produce. Further, our technology platform provides us with operating efficiencies that help lower our internal costs, which allows us to offer our tests at accessible price points. As a result, our efforts to build and should not be considered continually enhance our technology platform allow us to be part deliver comprehensive, adaptable, clinically actionable and affordable genetic analysis while maintaining a low cost per billable test, enabling us to efficiently meet the needs of this prospectus unless expressly noted. We may use our website (xxx.xxxxxxxxxx.xxx), press releases, public conference calls, public webcasts, Twitter and LinkedIn as means growing base of disclosing material non-public information and for complying with our disclosure obligations under Regulation FD. We also make available on or through our website certain reports and amendments to those reports that we file with or furnish to the SEC in accordance with the Securities Exchange Act of 1934, as amended (Exchange Act)customers. These include features of our Annual Reports on Form 10-Koffering have resulted in rapid volume growth since our commercial launch, our quarterly reports on Form 10-Qwith 23,899 billable tests delivered as of June 2019, 22,298 billable tests delivered in 2018, 16,578 billable tests delivered in 2017, and our current reports on Form 8- Kan aggregate of over 83,100 billable tests delivered to approximately 1,000 customers from inception through June 30, and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act. We make this information available on or through our website free of charge as soon as reasonably practicable after we electronically file the information with, or furnish it to, the SEC. The SEC also maintains a website that contains our SEC filings. The address for the SEC website is xxx.xxx.xxx. We use the Edgewise Therapeutics logo and other marks as trademarks in the United States and other countries. This prospectus contains references to our trademarks and service marks and to those belonging to other entities. Solely for convenience, trademarks and trade names referred to in this prospectus, including logos, artwork and other visual displays, may appear without the TM symbol, but such references are not intended to indicate in any way that we will not assert, to the fullest extent under applicable law, our rights or the rights of the applicable licensor to these trademarks and trade names. We do not intend our use or display of other entities’ trade names, trademarks or service marks to imply a relationship with, or endorsement or sponsorship of us by, any other entity. The Securities That May Be Offered We may offer or sell common stock, preferred stock, depositary shares, debt securities, warrants, subscription rights, purchase contracts and units in one or more offerings and in any combination. The aggregate offering price of the securities we sell pursuant to this prospectus will not exceed $400,000,000. Each time securities are offered with this prospectus, we will provide a prospectus supplement that will describe the specific amounts, prices and terms of the securities being offered and the net proceeds we expect to receive from that sale. The securities may be sold to or through underwriters, dealers or agents or directly to purchasers or as otherwise set forth in the section of this prospectus captioned “Plan of Distribution2019.” Each prospectus supplement will set forth the names of any underwriters, dealers, agents or other entities involved in the sale of securities described in that prospectus supplement and any applicable fee, commission or discount arrangements with them. Common Stock We may offer shares of our common stock, par value $0.0001 per share, either alone or underlying other registered securities convertible into our common stock. Holders of our common stock are entitled to receive dividends declared by our board of directors out of funds legally available for the payment of dividends, subject to rights, if any, of preferred stockholders. We have not paid dividends in the past and have no current plans to pay dividends. Each holder of common stock is entitled to one vote per share. The holders of common stock have no preemptive rights.

Appears in 1 contract

Samples: Prospectus Supplement

PROSPECTUS SUMMARY. This The following summary highlights selected some information that is presented in greater detail elsewhere, or incorporated by reference, in from this prospectus. It is not complete and does not contain all of the information that may be important to you and your should consider before making an investment decision. Before investing in our securities, you You should carefully read this entire prospectus, including the matters set forth under the section of this prospectus captioned “Risk Factors” section on page 3 and the disclosures to which that section refers you, the financial statements and related notes and the other more detailed information that we incorporate appearing elsewhere or incorporated by reference herein, including our Annual Report on Form 10-K and our Quarterly Reports on Form 10-Q. Unless into this prospectus before investing in any of the context indicates otherwise, references securities described in this prospectus to “Edgewise Therapeuticsprospectus. Overview Cancer Genetics, Inc.,” “Edgewise,” “we,” “our” Inc. supports the efforts of the biotechnology and “us” refer, collectively, to Edgewise Therapeutics, Inc., a Delaware corporation. Company Overview At Edgewise, patients are at the core of everything we do. We recognize that for patients with rare and debilitating diseases, every day without an effective treatment is a day too late and we are driven by this urgency to evolve disease knowledge with an aim pharmaceutical industries to develop novel innovative new drug therapies. Until the closing of the Business Disposals (as defined below) in July 2019, the Company was an emerging leader in enabling precision medicines for severe medicine in oncology by providing multi-disciplinary diagnostic and rare disorders driven by muscle dysfunctiondata solutions, facilitating individualized therapies through the Company’s diagnostic tests, services and molecular markers. Our intimate knowledge Following the Business Disposals, the Company currently has an extensive set of muscle biology anti-tumor referenced data based on predictive xenograft and biophysics along with our ability to identify and design muscle specific precision small molecules have enabled us to rapidly advance our lead product candidate into clinical development while advancing our preclinical pipeline. From this foundationsyngeneic tumor models from the acquisition of vivoPharm, we continue to build a leading, global biopharmaceutical company focused on rare diseases involving muscle in order to develop transformative precision medicines to treat and possibly cure these disorders. In less than five years, we have matured into a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of innovative treatments for severe, rare muscle disorders for which there is significant unmet medical need. Guided by our holistic drug discovery approach to targeting the muscle as an organ, we have combined our foundational expertise in muscle biology and small molecule engineering to build our proprietary, muscle-focused drug discovery platform. Our platform utilizes custom-built high throughput and translatable systems that measure integrated muscle function in whole organ extracts to identify small molecule precision medicines regulating key proteins in muscle tissue, initially focused on addressing rare neuromuscular and cardiac diseases. Since our inception Pty Ltd. (“vivoPharm”) in 2017, our precision medicine muscle platform has generated several to provide Discovery Services such as contract research services, focused primarily on unique specialized studies to guide drug discovery and development programs to address in the oncology and immuno-oncology fields. The Company’s tests and techniques target a variety wide range of muscle disorders. We are advancing one clinical-stage program and two preclinical programs. Our lead product candidateindications, EDG-5506, is an orally administered allosteric, selective, fast myofiber (type II) myosin small molecule inhibitor designed to address covering all ten of the root cause of dystrophinopathies including Duchenne muscular dystrophy (DMD) and Xxxxxx muscular dystrophy (BMD). Both of these disorders are rare and often debilitating diseases, and we estimate that top cancers in prevalence in the United States there are approximately 12,000 States, with additional unique capabilities offered by its FDA-cleared Tissue of Origin® test for identifying difficult to 15,000 DMD patients diagnose tumor types or poorly differentiated metastatic disease. The Company offers preclinical services such as predictive tumor models, human orthotopic xenografts and 4,000 to 5,000 BMD patients. As syngeneic immuno-oncology relevant tumor models in its Hershey, PA facility, and is a selective fast myosin inhibitor, EDG-5506 presents a novel mechanism leader in the field of action designed to selectively limit injurious stress caused by lack of dystrophin by moderating fast skeletal muscle myosin force development and thereby compensating for immuno-oncology preclinical services in the absence of functional dystrophin. Our preclinical data with EDG-5506 in animal models of muscular dystrophy demonstrated that selective regulation of fast (type II) myofiber contraction protected muscle from damage, reduced systemic fibrosis and improved measures of muscle function including strength and ability to engage in physical activities, which we believe may provide evidence of a disease modifying effect. A unique observation from our preclinical work is that EDG-5506 led to pronounced prevention of cardiac fibrosisUnited States. This service is a highly relevant finding, particularly if replicated in clinical observations, since cardiac myopathy is a major driver of mortality in both DMD supplemented with GLP toxicology and BMD. EDG-5506 was evaluated in a Phase 1 clinical trial designed to assess the safety, tolerability and pharmacokinetics (PK) of EDG-5506 in adult healthy volunteers (HVs) (Phase 1a) and in adults with BMD (Phase 1b). Our Phase 1a data in HVs demonstrated that EDG-5506 was generally well-tolerated and amenable to daily dosing. Our Phase 1b data in BMD patients demonstrated proof of concept by showing a significant reduction in key biomarkers of muscle damage. We believe EDG-5506 has potential therapeutic utility as either a standalone or combination therapy for patients suffering from rare muscular dystrophies, if approved. We also intend to develop two other muscle-focused precision medicines. Our second program, EDG-5440, is a next generation myosin ATPase modulator designed to target skeletal muscle in a specific set of rare neuromuscular diseases. Our third program, EDG-002, focuses on identification of novel mechanism cardiac modulators. We are initially pursuing a new target for inherited hypertrophic cardiomyopathy (HCM) in addition to exploring the potential of this novel mechanism across other cardiac disorders. Our preliminary preclinical studies offer evidence that our EDG-002 program has the potential to yield molecules that could become a new therapeutic option for the treatment of HCM as well as other cardiac disorders. We anticipate candidate selection of a novel cardiac modulator for inherited hypertrophic cardiomyopathy from our EDG-002 cardiac muscle program extended bioanalytical services in the second half of 2022. We believe our programs also offer substantial opportunities for us to expand into related rare diseases for which there are limited or no approved treatments. We are currently focusing on the development of EDG-5506 Company’s Australian-based facilities in Xxxxxxx, Xxxxxxxx, and anticipate advancing our preclinical programs into the next stage of development in the near term. While EDG-5440 and EDG-002 are important preclinical programs to usXxxxxx Plains, we have not needed to devote significant financial resources to these programs to date since they are still in preclinical development and have not yet advanced into clinical trialsSouth Australia. Corporate Information We were incorporated in Delaware in May 2017. Our principal executive offices are located at 0000 Xxxxxxxx Xxx.000 Xxxxx 00 Xxxxx, Xxxxxxx0xx Xxxxx, Xxxxxxxx Xxxxxxxxxx, Xxx Xxxxxx 00000. Our , and our telephone number is (000-) 000-0000. Our common stock is currently traded on The NASDAQ Capital Market under the symbol “CGIX.” We maintain a corporate website address is xxx.xxxxxxxxxx.xxxat www.cancer xxxxxxxx.xxx. Information contained on, or that can be accessed through, The contents of our website or any website is are not incorporated by reference into this prospectus and should not be considered to be a part of this prospectus unless expressly notedor relied upon in connection herewith. You should not rely on our website or any such information in making your decision whether to purchase our securities. We may use our website (xxx.xxxxxxxxxx.xxx)were incorporated in the State of Delaware on April 8, press releases1999. On July 16, public conference calls, public webcasts, Twitter and LinkedIn as means of disclosing material non-public information and for complying with our disclosure obligations under Regulation FD. We also make available on or through our website certain reports and amendments to those reports that 2014 we file with or furnish to the SEC in accordance with the Securities Exchange Act of 1934, as amended (Exchange Act). These include our Annual Reports on Form 10-K, our quarterly reports on Form 10-Q, and our current reports on Form 8- K, and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) purchased substantially all of the Exchange Actassets of Gentris Corporation, a laboratory specializing in pharmacogenomics profiling for therapeutic development, companion diagnostics and clinical trials, which previously supported our BioPharma Business. We make this information available on or through On October 9, 2015, we acquired substantially all the assets and assumed certain liabilities of Response Genetics, Inc., which previously supported our website free of charge as soon as reasonably practicable after Clinical Business. On August 15, 2017, we electronically file the information with, or furnish it to, the SEC. The SEC also maintains a website that contains our SEC filings. The address for the SEC website is xxx.xxx.xxx. We use the Edgewise Therapeutics logo and other marks as trademarks in the United States and other countries. This prospectus contains references to our trademarks and service marks and to those belonging to other entities. Solely for convenience, trademarks and trade names referred to in this prospectus, including logos, artwork and other visual displays, may appear without the TM symbol, but such references are not intended to indicate in any way that we will not assert, to the fullest extent under applicable law, our rights or the rights purchased all of the applicable licensor to these trademarks and trade namesoutstanding stock of vivoPharm, with its principal place of business in Victoria, Australia. We do not intend our use or display of other entities’ trade namesOn July 8, trademarks or service marks to imply a relationship with, or endorsement or sponsorship of us by, any other entity. The Securities That May Be Offered We may offer or sell common stock, preferred stock, depositary shares, debt securities, warrants, subscription rights, purchase contracts and units in one or more offerings and in any combination. The aggregate offering price of the securities we sell pursuant to this prospectus will not exceed $400,000,000. Each time securities are offered with this prospectus2019, we will provide a prospectus supplement that will describe the specific amounts, prices and terms of the securities being offered and the net proceeds we expect to receive from that sale. The securities may be sold to or through underwriters, dealers or agents or directly to purchasers or as otherwise set forth in the section of this prospectus captioned “Plan of Distribution.” Each prospectus supplement will set forth the names of any underwriters, dealers, agents or other entities involved in consummated the sale of securities described in that prospectus supplement our Clinical Business (the “Clinical Sale”), and any applicable feeon July 15, commission or discount arrangements with them. Common Stock We may offer shares 2019, we consummated the sale of our common stockBioPharma Business (the “BioPharma Sale” and, par value $0.0001 per sharetogether with the Clinical Sale, either alone or underlying other registered securities convertible into our common stock. Holders of our common stock are entitled to receive dividends declared by our board of directors out of funds legally available for the payment of dividends, subject to rights, if any, of preferred stockholders. We have not paid dividends in the past and have no current plans to pay dividends. Each holder of common stock is entitled to one vote per share. The holders of common stock have no preemptive rights“Business Disposals”).

Appears in 1 contract

Samples: Equity Distribution Agreement

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PROSPECTUS SUMMARY. This summary highlights selected information that is presented in greater detail elsewhere, or incorporated by reference, in from this prospectus. It prospectus and does not contain all of the information that may be important you need to you and consider in making your investment decision. Before investing in our securities, you You should carefully read this the entire prospectus, the applicable prospectus supplement and any related free writing prospectus, including the matters set forth risks of investing in our securities discussed under the section of this prospectus captioned heading “Risk Factors” contained in the applicable prospectus supplement and any related free writing prospectus, and under similar headings in the financial statements and related notes and other information documents that we incorporate are incorporated by reference hereininto this prospectus. You should also carefully read the information incorporated by reference into this prospectus, including our Annual Report on Form 10-K financial statements, and our Quarterly Reports on Form 10-Q. the exhibits to the registration statement of which this prospectus is a part. Unless the context indicates otherwise, references as used in this prospectus to prospectus, the terms Edgewise Therapeutics, Inc.Fulgent Genetics,” “EdgewiseFulgent,” “the Company,” “we,” “ourus” and “usourrefer, collectively, refer to Edgewise TherapeuticsFulgent Genetics, Inc., a Delaware corporation. Company Overview At EdgewiseAbout Fulgent Genetics, patients are at Inc. Fulgent is a growing technology company offering comprehensive genetic testing and providing physicians with clinically actionable diagnostic information they can use to improve the core quality of everything we dopatient care. We recognize have developed a proprietary technology platform that for patients with rare allows us to offer a broad and debilitating diseasesflexible test menu and continually expand and improve our proprietary genetic reference library, every day without an effective treatment is a day too late while maintaining accessible pricing, high accuracy and we are driven by this urgency to evolve disease knowledge with an aim to develop novel precision medicines for severe and rare disorders driven by muscle dysfunctioncompetitive turnaround times. Our intimate knowledge of muscle biology and biophysics along Combining next generation sequencing, or NGS, with our ability to identify and design muscle specific precision small molecules have enabled us to rapidly advance our lead product candidate into clinical development while advancing our preclinical pipeline. From this foundationtechnology platform, we continue perform full-gene sequencing with deletion/duplication analysis in single-gene tests; pre-established, multi-gene, disease-specific panels; and customized panels that can be tailored to build a leading, global biopharmaceutical company focused on rare diseases involving muscle in order to develop transformative precision medicines to treat and possibly cure these disorders. In less than five years, we have matured into a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of innovative treatments for severe, rare muscle disorders for which there is significant unmet medical need. Guided by our holistic drug discovery approach to targeting the muscle as an organ, we have combined our foundational expertise in muscle biology and small molecule engineering to build our proprietary, muscle-focused drug discovery platform. Our platform utilizes custom-built high throughput and translatable systems that measure integrated muscle function in whole organ extracts to identify small molecule precision medicines regulating key proteins in muscle tissue, initially focused on addressing rare neuromuscular and cardiac diseases. Since our inception in 2017, our precision medicine muscle platform has generated several programs to address a variety of muscle disorders. We are advancing one clinical-stage program and two preclinical programs. Our lead product candidate, EDG-5506, is an orally administered allosteric, selective, fast myofiber (type II) myosin small molecule inhibitor designed to address the root cause of dystrophinopathies including Duchenne muscular dystrophy (DMD) and Xxxxxx muscular dystrophy (BMD). Both of these disorders are rare and often debilitating diseases, and we estimate that in the United States there are approximately 12,000 to 15,000 DMD patients and 4,000 to 5,000 BMD patients. As a selective fast myosin inhibitor, EDG-5506 presents a novel mechanism of action designed to selectively limit injurious stress caused by lack of dystrophin by moderating fast skeletal muscle myosin force development and thereby compensating for the absence of functional dystrophin. Our preclinical data with EDG-5506 in animal models of muscular dystrophy demonstrated that selective regulation of fast (type II) myofiber contraction protected muscle from damage, reduced systemic fibrosis and improved measures of muscle function including strength and ability to engage in physical activities, which we believe may provide evidence of a disease modifying effect. A unique observation from our preclinical work is that EDG-5506 led to pronounced prevention of cardiac fibrosis. This is a highly relevant finding, particularly if replicated in clinical observations, since cardiac myopathy is a major driver of mortality in both DMD and BMD. EDG-5506 was evaluated in a Phase 1 clinical trial designed to assess the safety, tolerability and pharmacokinetics (PK) of EDG-5506 in adult healthy volunteers (HVs) (Phase 1a) and in adults with BMD (Phase 1b). Our Phase 1a data in HVs demonstrated that EDG-5506 was generally well-tolerated and amenable to daily dosing. Our Phase 1b data in BMD patients demonstrated proof of concept by showing a significant reduction in key biomarkers of muscle damage. We believe EDG-5506 has potential therapeutic utility as either a standalone or combination therapy for patients suffering from rare muscular dystrophies, if approved. We also intend to develop two other muscle-focused precision medicines. Our second program, EDG-5440, is a next generation myosin ATPase modulator designed to target skeletal muscle in a meet specific set of rare neuromuscular diseases. Our third program, EDG-002, focuses on identification of novel mechanism cardiac modulators. We are initially pursuing a new target for inherited hypertrophic cardiomyopathy (HCM) in addition to exploring the potential of this novel mechanism across other cardiac disorders. Our preliminary preclinical studies offer evidence that our EDG-002 program has the potential to yield molecules that could become a new therapeutic option for the treatment of HCM as well as other cardiac disorders. We anticipate candidate selection of a novel cardiac modulator for inherited hypertrophic cardiomyopathy from our EDG-002 cardiac muscle program in the second half of 2022customer needs. We believe our programs also offer substantial opportunities test menu offers more genes for testing than our competitors in today’s market, which enables us to expand provide expansive options for test customization and clinically actionable results. After launching our first commercial genetic tests in 2013, we have expanded our test menu to include approximately 18,000 single-gene tests and more than 900 panels that collectively test for approximately 5,700 genetic conditions, including various cancers, cardiovascular diseases, neurological disorders and pediatric conditions. A cornerstone of our business is our ability to provide expansive options and flexibility for all clients’ unique genetic testing needs. Genetic testing offers the possibility of early identification of a disease or a genetic predisposition to a disease and enhanced disease treatment and prognosis. As a result, we believe widespread genetic testing could enable significant health improvements and healthcare cost reductions by providing patients and clinicians with more advanced knowledge and options for personal health management plans. Due to these and other potential benefits, genetic testing has experienced significant growth in recent years. If this growth trend continues, we believe genetic testing will become part of standard medical care and the knowledge of a person’s unique genetic makeup could play a more important role in the practice of medicine. We believe this growth has been tempered in prior years, however, because many tests are prohibitively expensive, are produced through inefficient processes and often do not result in clinically actionable data. Through our technology platform, we have developed an offering that we believe addresses these industry challenges and provides a sustainable competitive advantage, both in today’s genetic testing market and as we seek to implement new diagnostic tools in the future. Our technology platform, which integrates sophisticated data comparison and suppression algorithms, adaptive learning software, advanced genetic diagnostics tools and integrated laboratory processes, allows us to offer a test menu with expansive genetic coverage. We believe the comprehensive data output and high detection rates of our tests, both made possible by this expansive genetic coverage, provide physicians with information they can readily incorporate into related rare diseases treatment decisions for their patients, which there are limited we refer to as clinical actionability. In addition, our technology platform facilitates our ability to perform customized genetic tests using our expansive library of genes, and we believe this flexibility increases the utility of the genetic data we produce. Further, our technology platform provides us with operating efficiencies that help lower our internal costs, which allows us to offer our tests at accessible price points. As a result, our efforts to build and continually enhance our technology platform allow us to deliver comprehensive, adaptable, clinically actionable and affordable genetic analysis while maintaining a low cost per billable test, enabling us to efficiently meet the needs of our growing base of customers. Since March 2020, we have commercially launched several tests for the detection of SARS-CoV-2, the virus that causes the novel coronavirus disease, or no approved treatmentsCOVID-19, including NGS and reverse transcription polymerase chain reaction – based tests, or RT-PCR tests. We have received Emergency Use Authorizations, or EUAs, from the U.S. Food and Drug Administration, or FDA, for the RT-PCR tests for the detection of SARS-CoV-2 using upper respiratory specimens (nasal, nasopharyngeal, and oropharyngeal swabs) and for our at-home testing service through Picture Genetics. Our at-home testing service for COVID-19 and RT-PCR- based test have been granted EUAs by the FDA only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. We are currently focusing on accepting patient samples directly to our Biosafety Level 2, or BSL-2, certified laboratory in Temple City, California where we have the development capacity to accept and process thousands of EDG-5506 and anticipate advancing our preclinical programs into the next stage samples per day with a typical turn-around time of development in the near term24-48 hours. While EDG-5440 and EDG-002 are important preclinical programs to usTo date, we have not needed to devote significant financial resources to these programs to date since they are still in preclinical development processed orders for our COVID-19 tests from a variety of customers, including governments and have not yet advanced into clinical trialsother laboratories. Corporate Information We were incorporated Information concerning the Company is contained in Delaware in May 2017. Our principal executive offices the documents that we file with the Securities and Exchange Commission, or the SEC, as a reporting company under the Securities Exchange Act of 1934, as amended, which are located accessible at 0000 Xxxxxxxx Xxx., Xxxxxxx, Xxxxxxxx 00000. Our telephone number is 000-000-0000xxx.xxx.xxx. Our website address is xxx.xxxxxxxxxx.xxxxxx.xxxxxxxxxxxxxxx.xxx. Information The information contained on, or that can be accessed through, our website or any website is not incorporated by reference into this prospectus and should not be considered to be a part of this prospectus unless expressly notedprospectus. Investors should not rely on any such information in deciding whether to purchase our common stock. We may use have included our website (xxx.xxxxxxxxxx.xxx), press releases, public conference calls, public webcasts, Twitter and LinkedIn as means of disclosing material non-public information and for complying with our disclosure obligations under Regulation FD. We also make available on or through our website certain reports and amendments to those reports that we file with or furnish to the SEC in accordance with the Securities Exchange Act of 1934, as amended (Exchange Act). These include our Annual Reports on Form 10-K, our quarterly reports on Form 10-Q, and our current reports on Form 8- K, and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act. We make this information available on or through our website free of charge as soon as reasonably practicable after we electronically file the information with, or furnish it to, the SEC. The SEC also maintains a website that contains our SEC filings. The address for the SEC website is xxx.xxx.xxx. We use the Edgewise Therapeutics logo and other marks as trademarks in the United States and other countries. This prospectus contains references to our trademarks and service marks and to those belonging to other entities. Solely for convenience, trademarks and trade names referred to in this prospectusprospectus solely as an inactive textual reference. Our mailing address is 0000 Xxxxx Xxxxx Xxxxxx, including logosSuite 205, artwork and other visual displaysTemple City, may appear without the TM symbol, but such references are not intended to indicate in any way that we will not assert, to the fullest extent under applicable law, our rights or the rights of the applicable licensor to these trademarks and trade namesCalifornia 91780. We do not intend our use or display of other entities’ trade names, trademarks or service marks to imply a relationship with, or endorsement or sponsorship of us by, any other entityOur telephone number is (626) 350- 0537. The Securities That We May Be Offered Offer We may offer or sell shares of our common stock, preferred stock, depositary shares, various series of debt securities and warrants to purchase any of such securities, warrantsor units to purchase any combination thereof, subscription rightswith a total value of up to $300,000,000 from time to time under this prospectus, purchase contracts together with any applicable prospectus supplement and units in one or more offerings any related free writing prospectus, at prices and in any combinationon terms to be determined by market conditions at the time of the offering. The aggregate offering price This prospectus provides you with a general description of the securities we sell pursuant to this prospectus will not exceed $400,000,000may offer. Each time we offer a type or series of securities are offered with under this prospectus, we will provide a prospectus supplement that will describe the specific amounts, prices and other important terms of the securities, including, to the extent applicable: • designation or classification; • aggregate principal amount or aggregate offering price; • maturity, if applicable; • original issue discount, if any; • rates and times of payment of interest or dividends, if any; • redemption, conversion, exchange or sinking fund terms, if any; • conversion or exchange prices or rates, if any, and, if applicable, any provisions for changes to or adjustments in the conversion or exchange prices or rates and in the securities being offered or other property receivable upon conversion or exchange; • ranking; • restrictive covenants, if any; • voting or other rights, if any; and the net proceeds we expect to receive from that sale• important United States federal income tax considerations. The prospectus supplement and any related free writing prospectus that we may authorize to be provided to you may also add, update or change information contained in this prospectus or in documents we have incorporated by reference. However, no prospectus supplement or free writing prospectus will offer a security that is not registered and described in this prospectus at the time of the effectiveness of the registration statement of which this prospectus is a part. We may sell the securities may be sold directly to investors or through underwriters, dealers or agents agents. We, and our underwriters or directly agents, reserve the right to purchasers accept or as otherwise set forth reject all or part of any proposed purchase of securities. If we do offer securities through underwriters or agents, we will include in the section of this applicable prospectus captioned “Plan of Distribution.” Each prospectus supplement will set forth supplement: • the names of any underwritersthose underwriters or agents; • applicable fees, dealersdiscounts and commissions to be paid to them; • details regarding over-allotment options, agents or other entities involved in if any; and • the estimated net proceeds to us. This prospectus may not be used to consummate a sale of securities described in that unless it is accompanied by a prospectus supplement and any applicable fee, commission or discount arrangements with them. Common Stock We may offer shares of our common stock, par value $0.0001 per share, either alone or underlying other registered securities convertible into our common stock. Holders of our common stock are entitled to receive dividends declared by our board of directors out of funds legally available for the payment of dividends, subject to rights, if any, of preferred stockholders. We have not paid dividends in the past and have no current plans to pay dividends. Each holder of common stock is entitled to one vote per share. The holders of common stock have no preemptive rightssupplement.

Appears in 1 contract

Samples: Prospectus Supplement

PROSPECTUS SUMMARY. This summary highlights selected information that is presented contained elsewhere in greater detail elsewhere, this prospectus or incorporated by reference, reference in this prospectus. It , and does not contain all of the information that may be important you need to you and consider in making your investment decision. Before investing in our securities, you You should carefully read this the entire prospectus, the applicable prospectus supplement and any related free writing prospectus, including the matters set forth risks of investing in our securities discussed under the section of this prospectus captioned sections titled “Risk Factors” contained in this prospectus, the applicable prospectus supplement and any related free writing prospectus, and under similar sections in the financial statements and related notes and other documents that are incorporated by reference into this prospectus. You should also carefully read the other information that we incorporate incorporated by reference hereininto this prospectus, including our Annual Report on Form 10-K consolidated and our Quarterly Reports on Form 10-Q. Unless condensed consolidated financial statements, and the context indicates otherwise, references in exhibits to the registration statement of which this prospectus is a part. Rani Therapeutics Holdings, Inc. Overview We are a clinical stage biotherapeutics company focusing on advancing technologies to “Edgewise Therapeutics, Inc.,” “Edgewise,” “we,” “our” and “us” refer, collectivelyenable the administration of biologics orally, to Edgewise Therapeuticsprovide patients, Inc.physicians, and healthcare systems with a Delaware corporation. Company Overview At Edgewise, patients are at the core of everything we do. We recognize that for patients with rare and debilitating diseases, every day without an effective treatment is a day too late and we are driven by this urgency convenient alternative to evolve disease knowledge with an aim to develop novel precision medicines for severe and rare disorders driven by muscle dysfunction. Our intimate knowledge of muscle biology and biophysics along with our ability to identify and design muscle specific precision small molecules have enabled us to rapidly advance our lead product candidate into clinical development while advancing our preclinical pipeline. From this foundation, we continue to build a leading, global biopharmaceutical company focused on rare diseases involving muscle in order to develop transformative precision medicines to treat and possibly cure these disorders. In less than five years, we have matured into a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of innovative treatments for severe, rare muscle disorders for which there is significant unmet medical need. Guided by our holistic drug discovery approach to targeting the muscle as an organ, we have combined our foundational expertise in muscle biology and small molecule engineering to build our proprietary, muscle-focused drug discovery platform. Our platform utilizes custom-built high throughput and translatable systems that measure integrated muscle function in whole organ extracts to identify small molecule precision medicines regulating key proteins in muscle tissue, initially focused on addressing rare neuromuscular and cardiac diseases. Since our inception in 2017, our precision medicine muscle platform has generated several programs to address a variety of muscle disorderspainful injections. We are advancing one clinicala portfolio of oral biologic therapeutics using our proprietary delivery technology. We have developed and clinically tested a drug-agnostic oral delivery platform, the RaniPill capsule, which can deliver any drug, including large molecules such as peptides, proteins, and antibodies. The current RaniPill capsule can deliver up to a 3 mg dose of drug with high bioavailability. We are also developing a high-capacity version known as the RaniPill HC, which is in preclinical stage program and two preclinical programswhich is intended to enable delivery of drug payloads up to 20 mg with high bioavailability. Our lead product candidate, EDG-5506, current RaniPill capsule is an optimized to orally administered allosteric, selective, fast myofiber (type II) myosin small molecule inhibitor designed to address the root cause deliver a variety of dystrophinopathies including Duchenne muscular dystrophy (DMD) and Xxxxxx muscular dystrophy (BMD). Both of these disorders are rare and often debilitating diseasesbiologic therapeutics, and we estimate that in the United States there are approximately 12,000 to 15,000 DMD patients and 4,000 to 5,000 BMD patients. As a selective fast myosin inhibitor, EDG-5506 presents a novel mechanism of action designed to selectively limit injurious stress caused by lack of dystrophin by moderating fast skeletal muscle myosin force development and thereby compensating for the absence of functional dystrophin. Our preclinical data with EDG-5506 in animal models of muscular dystrophy demonstrated that selective regulation of fast (type II) myofiber contraction protected muscle from damage, reduced systemic fibrosis and improved measures of muscle function including strength and ability to engage in physical activities, which we believe may provide evidence of a disease modifying effect. A unique observation from our preclinical work is that EDG-5506 led to pronounced prevention of cardiac fibrosis. This is a highly relevant finding, particularly if replicated in clinical observations, since cardiac myopathy is a major driver of mortality in both DMD and BMD. EDG-5506 was evaluated in a Phase 1 clinical trial designed to assess the safety, tolerability and pharmacokinetics (PK) of EDG-5506 in adult healthy volunteers (HVs) (Phase 1a) and in adults with BMD (Phase 1b). Our Phase 1a data in HVs demonstrated that EDG-5506 was generally well-tolerated and amenable to daily dosing. Our Phase 1b data in BMD patients demonstrated proof of concept by showing a significant reduction in key biomarkers of muscle damage. We believe EDG-5506 has potential therapeutic utility as either a standalone or combination therapy for patients suffering from rare muscular dystrophies, if approved. We also intend to develop two other muscle-focused precision medicines. Our second program, EDG-5440, is a next generation myosin ATPase modulator designed to target skeletal muscle in a specific set of rare neuromuscular diseases. Our third program, EDG-002, focuses on identification of novel mechanism cardiac modulators. We are initially pursuing a new target for inherited hypertrophic cardiomyopathy (HCM) in addition to exploring the potential of this novel mechanism across other cardiac disorders. Our preliminary preclinical studies offer evidence that our EDG-002 program has the potential to yield molecules that could become a new therapeutic option for the treatment of HCM as well as other cardiac disorders. We anticipate candidate selection of a novel cardiac modulator for inherited hypertrophic cardiomyopathy from our EDG-002 cardiac muscle program in the second half of 2022. We believe our programs also offer substantial opportunities for us to expand into related rare diseases for which there are limited or no approved treatments. We are currently focusing on the advancing development of EDG-5506 and anticipate advancing our preclinical programs into the next stage of development in the near term. While EDG-5440 and EDG-002 are important preclinical programs RaniPill HC to us, we have not needed to devote significant financial resources to these programs to date since they are still in preclinical development and have not yet advanced into clinical trialsaddress biologics with higher dosing requirements. Corporate Information We were incorporated Rani Holdings was formed as a Delaware corporation in Delaware in May 2017April 2021 for the purpose of facilitating an initial public offering, or the IPO, of its Class A common stock, to facilitate certain organizational transactions, and to operate the business of Rani Therapeutics, LLC, or Rani LLC, and its consolidated subsidiary Rani Management Services, Inc., or RMS. In connection with the IPO, we established a holding company structure with Rani Holdings as a holding company and its principal asset is the Class A common units of Rani LLC that it owns. As the sole managing member of Rani LLC, Rani Holdings operates and controls all of Rani LLC’s operations, and through Rani LLC and its subsidiary, conducts all of Rani LLC’s business. Our principal executive offices are located at 0000 Xxxxxxxx Xxx., XxxxxxxXxx Xxxx, Xxxxxxxx Xxxxxxxxxx 00000. Our telephone number is 000-000-0000. Our website address is xxx.xxxxxxxxxx.xxxxxx.xxxxxxxxxxxxxxxx.xxx. Information contained on, or that can be accessed through, References to our website or any address do not constitute incorporation by reference of the information contained on the website, and the information contained on the website is not incorporated by reference into this prospectus and should not be considered to be part of this prospectus unless expressly noteddocument. We may use our website (xxx.xxxxxxxxxx.xxx)are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012. As such, press releaseswe are eligible for exemptions from various reporting requirements applicable to other public companies that are not emerging growth companies, public conference callsincluding, public webcastsbut not limited to, Twitter not being required to comply with the auditor attestation requirements of Section 404 of the Xxxxxxxx-Xxxxx Act of 2002 and LinkedIn as means of disclosing material non-public information and for complying with our reduced disclosure obligations under Regulation FD. We also make available on or through our website certain reports and amendments to those reports that we file with or furnish to the SEC in accordance with the Securities Exchange Act of 1934, as amended (Exchange Act). These include our Annual Reports on Form 10-K, our quarterly reports on Form 10-Q, and our current reports on Form 8- K, and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act. We make this information available on or through our website free of charge as soon as reasonably practicable after we electronically file the information with, or furnish it to, the SEC. The SEC also maintains a website that contains our SEC filings. The address for the SEC website is xxx.xxx.xxx. We use the Edgewise Therapeutics logo and other marks as trademarks in the United States and other countries. This prospectus contains references to our trademarks and service marks and to those belonging to other entities. Solely for convenience, trademarks and trade names referred to in this prospectus, including logos, artwork and other visual displays, may appear without the TM symbol, but such references are not intended to indicate in any way that we will not assert, to the fullest extent under applicable law, our rights or the rights of the applicable licensor to these trademarks and trade names. We do not intend our use or display of other entities’ trade names, trademarks or service marks to imply a relationship with, or endorsement or sponsorship of us by, any other entity. The Securities That May Be Offered We may offer or sell common stock, preferred stock, depositary shares, debt securities, warrants, subscription rights, purchase contracts and units in one or more offerings and in any combination. The aggregate offering price of the securities we sell pursuant to this prospectus will not exceed $400,000,000. Each time securities are offered with this prospectus, we will provide a prospectus supplement that will describe the specific amounts, prices and terms of the securities being offered and the net proceeds we expect to receive from that sale. The securities may be sold to or through underwriters, dealers or agents or directly to purchasers or as otherwise set forth in the section of this prospectus captioned “Plan of Distributionregarding executive compensation.” Each prospectus supplement will set forth the names of any underwriters, dealers, agents or other entities involved in the sale of securities described in that prospectus supplement and any applicable fee, commission or discount arrangements with them. Common Stock We may offer shares of our common stock, par value $0.0001 per share, either alone or underlying other registered securities convertible into our common stock. Holders of our common stock are entitled to receive dividends declared by our board of directors out of funds legally available for the payment of dividends, subject to rights, if any, of preferred stockholders. We have not paid dividends in the past and have no current plans to pay dividends. Each holder of common stock is entitled to one vote per share. The holders of common stock have no preemptive rights.

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Samples: Prospectus Supplement

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