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SLDB

Solid Biosciences Inc. Nasdaq Global Select
$10.42
Open: $8.74 High: $10.98 Low: $8.51 Close: $9.78
Range: 2021-03-02 - 2021-03-03
Volume: 4,121,135
Market: Extended-hours
Powered by Finage Stock APIDelayed data
SLDB
Solid Biosciences Inc. 141 Portland Street Cambridge MA, 2139 http://www.solidbio.com
Solid Biosciences Inc is a life science company engaged in developing therapies for Duchenne muscular dystrophy. Its product candidate, SGT-001, is a gene transfer under development to restore functional dystrophin protein expression in patients' muscles.
  • CEO: Ilan Ganot
  • Employees: 60
  • Sector: Healthcare
  • Industry: Drug Manufacturers
SLDB News
Latest news about the SLDB
  • Efficacy and Safety Data from Solid Biosciences’ Ongoing IGNITE DMD Phase I/II Clinical Trial to be Presented at the 2021 MDA Clinical & Scientific Conference

    -IGNITE DMD Principal Investigator, Dr. Barry Byrne, to present efficacy and safety data from the ongoing IGNITE DMD trial on Thursday, March 18- -Company to host external key opinion leaders at a symposium to discuss Real World Outcomes Measures in Duchenne Muscular Dystrophy during the conference- -Company to host conference call to discuss the interim one-year clinical trial data and fourth quarter and full year 2020 financial results on Monday, March 15 at 4:30 PM ET- CAMBRIDGE, Mass., Feb. 24, 2021 (GLOBE NEWSWIRE) -- Solid Biosciences Inc. (Nasdaq: SLDB), a life sciences company focused on advancing meaningful therapies for Duchenne muscular dystrophy (Duchenne), announced that one-year efficacy and safety data from the ongoing IGNITE-DMD Phase I/II study of SGT-001 microdystrophin gene therapy in patients with Duchenne muscular dystrophy (Duchenne) will be presented at the 2021 MDA Virtual Clinical & Scientific Conference. Barry Byrne, MD, PhD, Associate Chair of Pediatrics and Director of the Powell Gene Therapy Center at the University of Florida, and IGNITE DMD principal investigator, will present the data during a virtual oral session on Thursday, March 18, 2021 at 4 PM ET. Details of the MDA presentation: Session Title: IGNITE-DMD: Phase I/II Ascending Dose Study of Single IV Infusion of SGT-001 Microdystrophin Gene Therapy for DMD: One Year Efficacy and Safety Results Session Date: Thursday, March 18, 2021 4 PM ET Registration: The public must be registered to view live-broadcast sessions, on-demand videos, virtual networking sessions, exhibits and poster sessions. To register, visit: https://mdavirtualconference.org/en/registration Symposium with Key Opinion LeadersAlso, on March 18, Solid Biosciences will sponsor a symposium, “Real World Outcome Measures in Duchenne Muscular Dystrophy: Current and Novel Assessments of Meaningful Patient Benefit” at 12 PM ET. The symposium will feature: Valeria Ricotti, MD, Co-Founder, Executive Vice-President & Chief Medical Officer at DiNAQOR AGChad R. Heatwole, MD, MS-CI, Professor of Neurology, Associate Director of the Center for Health + Technology (CHeT) and CHeT Outcomes Division Director at the University of Rochester Medical CenterCraig M. McDonald, MD, Professor and Chair of the Department of Physical Medicine and Rehabilitation at the University of California, Davis Registration: The public must be registered to view live-broadcast sessions, on-demand videos, virtual networking sessions, exhibits and poster sessions. Company Conference CallSolid Biosciences’ management will host a conference call beginning at 4:30 PM ET on Monday, March 15, 2021 to discuss the IGNITE DMD data that will be presented at the MDA Conference, the Company’s fourth quarter and full year 2020 financial results and recent business developments. A live webcast of the call will be available on the Company's website at www.solidbio.com under the “News & Events” tab in the Investor Relations section, or by clicking here. Participants may also access the call, by dialing 866-763-0341 for domestic callers or 703-871-3818 for international callers, referencing conference ID# 1669808. The archived webcast will be available in the “News and Events” section of the Company's website. About Solid BiosciencesSolid Biosciences is a life sciences company focused on advancing transformative treatments to improve the lives of patients living with Duchenne. Disease-focused and founded by a family directly impacted by Duchenne, our mandate is simple yet comprehensive – work to address the disease at its core by correcting the underlying mutation that causes Duchenne with our lead gene therapy candidate, SGT-001. For more information, please visit www.solidbio.com. Investor Contact:David CareyFINN Partners212-867-1768David.Carey@finnpartners.com Media Contact:Erich SandovalFINN Partners917-497-2867Erich.Sandoval@finnpartners.com

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  • Solid Biosciences to Present at Upcoming Investor Conferences

    CAMBRIDGE, Mass., Feb. 17, 2021 (GLOBE NEWSWIRE) -- Solid Biosciences Inc. (Nasdaq: SLDB), a life sciences company focused on advancing meaningful therapies for Duchenne muscular dystrophy (Duchenne), today announced that Joel Schneider, PhD, Chief Technology Officer, and Cathryn Clary, MD, MBA, Acting Chief Medical Officer, will participate at the following two upcoming investor conferences: SVB Leerink 10th Annual Global Healthcare ConferenceFireside chat on Wednesday, February 24, 2021 at 1:40 p.m. ET. Barclays Global Healthcare ConferenceFireside chat on Thursday, March 11, 2021 at 9:45 a.m. ET. A live webcast of these presentations will be available on the Company’s investor relations website, under the Events page accessible here: https://investors.solidbio.com/news-and-events/events. A replay will be available on the Company's website following the event. About Solid BiosciencesSolid Biosciences is a life sciences company focused on advancing transformative treatments to improve the lives of patients living with Duchenne. Disease-focused and founded by a family directly impacted by Duchenne, our mandate is simple yet comprehensive – work to address the disease at its core by correcting the underlying mutation that causes Duchenne with our lead gene therapy candidate, SGT-001. For more information, please visit www.solidbio.com. Investor Contact:David CareyFINN Partners212-867-1768David.Carey@finnpartners.com Media Contact:Erich SandovalFINN Partners917-497-2867Erich.Sandoval@finnpartners.com

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  • Sarepta Stock Dropped 50% After Gene-Therapy Setback. What to Do Now.

    The shares lost about half of their value after the company disclosed disappointing trial results for a gene therapy meant to cure Duchenne muscular dystrophy.

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  • Why Solid Biosciences Stock Is Sinking Today

    The drop came after Sarepta Therapeutics (NASDAQ: SRPT) reported disappointing clinical results for experimental gene therapy SRP-9001 in treating rare genetic disease Duchenne muscular dystrophy (DMD). Sarepta's problem was that SRP-9001 didn't meet the primary functional endpoint of its clinical study. Just because SRP-9001 failed in a clinical study doesn't necessarily mean that SGT-001 will.

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  • Solid Biosciences to Present at 39th Annual J.P. Morgan Healthcare Conference

    CAMBRIDGE, Mass., Jan. 06, 2021 (GLOBE NEWSWIRE) -- Solid Biosciences Inc. (Nasdaq: SLDB), a life sciences company focused on advancing meaningful therapies for Duchenne muscular dystrophy (Duchenne), today announced that Ilan Ganot, Chief Executive Officer, President and Co-Founder, will present at the 39th Annual J.P. Morgan Healthcare Conference on Thursday, January 14, 2021 at 8:20 am ET. Following the prepared remarks, several members of the leadership team will be available for Q&A. Institutional investors interested in meeting with management during the conference may reach out to their J.P. Morgan representative.A live webcast of the presentation will be available on the Events page of the Investors section of the Company website or by clicking here. A webcast replay will be archived for approximately 30 days on the Events page.About Solid Biosciences Solid Biosciences is a life sciences company focused on advancing transformative treatments to improve the lives of patients living with Duchenne. Disease-focused and founded by a family directly impacted by Duchenne, our mandate is simple yet comprehensive – work to address the disease at its core by correcting the underlying mutation that causes Duchenne with our lead gene therapy candidate, SGT-001. For more information, please visit www.solidbio.com.Investor Contact: David Carey FINN Partners 212-867-1768 David.Carey@finnpartners.comMedia Contact: Erich Sandoval FINN Partners 917-497-2867 Erich.Sandoval@finnpartners.com

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  • Ultragenyx (RARE) Surges on Product Approvals, Pipeline Progress

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  • Is SLDB A Good Stock To Buy Now?

    In this article we will take a look at whether hedge funds think Solid Biosciences Inc. (NASDAQ:SLDB) is a good investment right now. We check hedge fund and billionaire investor sentiment before delving into hours of research. Hedge funds spend millions of dollars on Ivy League graduates, unconventional data sources, expert networks, and get tips […]

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  • Solid Biosciences Announces $90 Million Private Placement

    CAMBRIDGE, Mass., Dec. 11, 2020 (GLOBE NEWSWIRE) -- Solid Biosciences Inc. (Nasdaq: SLDB), a life sciences company focused on advancing meaningful therapies for Duchenne muscular dystrophy (Duchenne), today announced that it has entered into a securities purchase agreement with a select group of institutional investors and accredited investors for a $90 million private placement, which is expected to close on or about December 15, 2020, subject to the satisfaction of customary closing conditions. The private placement includes new investors Suvretta Capital Management, LLC and Aspire Capital Fund, LLC and existing investors, including RA Capital Management, Perceptive Advisors, LLC, Bain Capital Life Sciences, EcoR1 Capital, LLC, Boxer Capital, and Ikarian Capital, LLC, as well as certain board members and executive officers.Barclays acted as the exclusive placement agent to the Company in connection with the private placement.In this private placement, the Company is selling 24,324,320 shares of common stock at a price of $3.70 per share.The Company expects to use net proceeds from the private placement to fund research and development expenses, including the advancement of SGT-001, and for working capital and other general corporate purposes.The securities to be sold in the private placement have not been registered under the Securities Act of 1933, as amended (the “Securities Act”), or any state or other applicable jurisdiction’s securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions’ securities laws. The Company has agreed to file a registration statement with the U.S. Securities and Exchange Commission (the “SEC”) registering the resale of the shares of common stock issued in the private placement no later than the 120th day after the closing of the private placement.This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any offer, solicitation or sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful. Any offering of the securities under the resale registration statement will only be made by means of a prospectus.About Solid BiosciencesSolid Biosciences is a life sciences company focused on advancing transformative treatments to improve the lives of patients living with Duchenne. Disease-focused and founded by a family directly impacted by Duchenne, our mandate is simple yet comprehensive – work to address the disease at its core by correcting the underlying mutation that causes Duchenne with our lead gene therapy candidate, SGT-001.Cautionary Note Regarding Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, those regarding:  the anticipated closing of the private placement; the use of proceeds from the private placement; the filing of a registration statement to register the resale of the shares to be issued and sold in the private placement; and Solid’s plans, strategies and prospects for its business. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from current expectations and beliefs, including but not limited to: whether the conditions for the closing of the private placement will be satisfied; risks associated with Solid’s ability to resume and/or continue IGNITE DMD on the timeline expected or at all, obtain and maintain necessary approvals from the FDA and other regulatory authorities, obtain and maintain the necessary approvals from investigational review boards at IGNITE DMD clinical trial sites and the IGNITE DMD independent data safety monitoring board, enroll patients in IGNITE DMD, continue to advance SGT-001 in clinical trials, replicate in clinical trials positive results found in preclinical studies and earlier stages of clinical development, advance the development of its product candidates under the timelines it anticipates in current and future clinical trials, successfully optimize and scale its manufacturing process, obtain, maintain or protect intellectual property rights related to its product candidates, compete successfully with other companies that are seeking to develop Duchenne treatments and gene therapies, manage expenses, and raise the substantial additional capital needed, on the timeline necessary, to continue development of SGT-001, achieve its other business objectives and continue as a going concern; and other important risk factors set forth under the caption “Risk Factors” in Solid’s most recent quarterly report on Form 10-Q and its other filings with the SEC. Any forward-looking statements contained in this press release speak only as of the date hereof, and Solid specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.Investor Contact: David Carey FINN Partners 212-867-1768 David.Carey@finnpartners.comMedia Contact: Erich Sandoval FINN Partners 917-497-2867 Erich.Sandoval@finnpartners.com

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  • Are Options Traders Betting on a Big Move in Solid Biosciences (SLDB) Stock?

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  • Solid Biosciences Reports Third Quarter 2020 Financial Results and Provides Business Update

    –IGNITE DMD clinical trial expected to resume dosing in the first quarter of 2021– -Collaboration with Ultragenyx creates opportunities to develop additional gene therapies for Duchene muscular dystrophy-    – Enhanced cash position resulting from Ultragenyx collaboration and fund-raising activity expected to provide financial runway into the second half of 2021 –– Conference call and webcast scheduled for 8:30 AM ET –CAMBRIDGE, Mass., Nov. 05, 2020 (GLOBE NEWSWIRE) -- Solid Biosciences Inc. (Nasdaq: SLDB), a life sciences company focused on advancing meaningful therapies for Duchenne muscular dystrophy (Duchenne), today reported financial results for the third quarter ended September 30, 2020 and provided a business update.“With the FDA’s lifting of the clinical hold on the IGNITE DMD trial, we are well underway in completing the activities necessary to resume dosing, which we expect will occur in the first quarter of 2021,” said Ilan Ganot, Chief Executive Officer, President and Co-Founder of Solid Biosciences. “This important event and establishing a strategic collaboration with Ultragenyx to develop additional gene therapies for Duchenne mark important progress toward our goal of improving the lives of patients living with Duchenne. We are also increasing production of SGT-001 using our improved manufacturing process in support of dosing additional patients in 2021. Additionally, we strengthened our balance sheet with additional capital from the Ultragenyx collaboration and our recent at-the-market, or ATM, equity financing, both of which will support our planned clinical advancement of SGT-001.”Recent Developments * In October 2020, Solid announced that the U.S. Food and Drug Administration (FDA) lifted the clinical hold placed on the Company’s IGNITE DMD Phase I/II clinical trial. Solid expects to resume dosing in the clinical trial in the first quarter of 2021. * Solid implemented and shared with the FDA manufacturing process changes that remove the majority of empty viral capsids. The improved process is averaging approximately 90% full capsids, allowing target dosing to be achieved with fewer viral particles. * Solid submitted data from a new, quantitative, in vitro microdystrophin expression assay that demonstrates comparability between SGT-001 manufactured by the two processes. * Solid is reducing the maximum weight of the next two patients dosed to 18 kg. This reduction, in conjunction with the delivery of fewer viral particles as a result of the company’s manufacturing process improvements, will reduce patients’ total viral load while continuing dosing at the 2E14 vg/kg dose. * Solid has amended the IGNITE DMD clinical protocol to include the prophylactic use of both anti-complement inhibitor eculizumab and C1 esterase inhibitor, and an increase in prednisone dose in the first month post dosing. * Solid also provided the FDA with updated functional efficacy data (including 6-Minute Walk Test and North Star Ambulatory Assessment data) for all patients dosed to date in IGNITE DMD. * In October 2020, Solid and Ultragenyx Pharmaceutical (Ultragenyx) announced a strategic collaboration to develop and commercialize new gene therapies for Duchenne. The parties will collaborate to develop products that combine Solid’s differentiated microdystrophin construct and Ultragenyx’s HeLa producer cell line (PCL) manufacturing platform for adeno-associated virus (AAV) vectors using AAV8 variants. The goal of the collaboration is to expand the pipeline of potential gene therapies for patients living with Duchenne. * Ultragenyx made a $40 million investment in Solid at a 33% premium. * Ultragenyx has also agreed to pay up to $255 million in cumulative milestone payments per product upon achievement of specified milestone events, and tiered royalties on worldwide net sales. Upon achievement of proof-of-concept, Solid has the right to opt-in to co-fund collaboration programs in return for participation in a profit share or increased royalty payments. * Solid retains full rights to SGT-001 as well as the opportunity to establish additional partnerships around SGT-001 or the Company’s proprietary and differentiated microdystrophin construct outside of AAV8 variants. * In October 2020, Solid announced that it sold shares of its common stock pursuant to a sales agreement dated March 13, 2019, between the Company and Jefferies LLC that resulted in gross proceeds of $23.9 million (ATM Sale). Financial HighlightsResearch and development expenses for the third quarter of 2020 were $16.0 million, compared to $22.8 million for the third quarter of 2019. Research and development expenses for the first nine months of 2020 were $49.2 million, compared to $67.7 million for the first nine months of 2019. The decrease was primarily attributable to a reduction in personnel and facility related expenses as a result of the restructuring that occurred in January 2020, as well as lower manufacturing costs and a decrease in costs related to other product candidates as the Company focuses on advancing SGT-001.General and administrative expenses for the third quarter of 2020 were $5.2 million, compared to $6.9 million for the third quarter of 2019. General and administrative expenses for the first nine months of 2020 were $16.0 million, compared to $19.3 million for the first nine months of 2019. The decrease was primarily attributable to decreased personnel costs and corporate expenses partially due to the restructuring that occurred in January 2020.Net loss for the third quarter of 2020 was $21.2 million, compared to $29.3 million for the third quarter of 2019. Net loss for the first nine months of 2020 was $66.9 million, compared to $85.4 million for the first nine months of 2019.Solid had $24.8 million in cash and cash equivalents as of September 30, 2020. The Company expects that its cash and cash equivalents, combined with proceeds of $40 million from the issuance and sale of shares of common stock to Ultragenyx and the net proceeds of $23.2 million from the ATM Sale will enable Solid to fund its operating expenses into the second half of 2021.Conference Call Management will host a webcast and conference call to discuss Solid’s third quarter 2020 financial results and business update today, November 5, 2020, at 8:30 AM ET.A live webcast of the call will be available on the Company's website at www.solidbio.com under the “News & Events” tab in the Investor Relations section, or by clicking here. Participants may also access the call, by dialing 866-763-0341 for domestic callers or 703-871-3818 for international callers.The archived webcast will be available for in the “News and Events” section of the Company's website.About SGT-001 Solid’s SGT-001 is a novel adeno-associated viral (AAV) vector-mediated gene transfer therapy designed to address the underlying genetic cause of Duchenne. Duchenne is caused by mutations in the dystrophin gene that result in the absence or near absence of dystrophin protein. SGT-001 is a systemically administered candidate that delivers a synthetic dystrophin gene, called microdystrophin, to the body. This microdystrophin encodes for a functional protein surrogate that is expressed in muscles and stabilizes essential associated proteins, including neuronal nitric oxide synthase nNOS. Data from Solid’s preclinical program suggests that SGT-001 has the potential to slow or stop the progression of Duchenne, regardless of genetic mutation or disease stage.SGT-001 is based on pioneering research in dystrophin biology by Dr. Jeffrey Chamberlain of the University of Washington and Dr. Dongsheng Duan of the University of Missouri. SGT-001 has been granted Rare Pediatric Disease Designation, or RPDD, and Fast Track Designation in the United States and Orphan Drug Designations in both the United States and European Union.About Solid Biosciences Solid Biosciences is a life sciences company focused on advancing transformative treatments to improve the lives of patients living with Duchenne. Disease-focused and founded by a family directly impacted by Duchenne, our mandate is simple yet comprehensive – work to address the disease at its core by correcting the underlying mutation that causes Duchenne with our lead gene therapy candidate, SGT-001. For more information, please visit www.solidbio.com.Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the timing and ability of the Company to resume dosing and move the IGNITE DMD clinical trial forward, the safety or potential efficacy of SGT-001, the sufficiency of the Company’s cash and cash equivalents to fund its operations, potential milestone payments or royalty payments in connection with the Ultragenyx collaboration and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” “working” and similar expressions. Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. These risks and uncertainties include, but are not limited to, risks associated with the Company’s ability to resume and/or continue IGNITE DMD on the timeline expected or at all; obtain and maintain necessary approvals from the FDA and other regulatory authorities; obtain and maintain the necessary approvals from investigational review boards at IGNITE DMD clinical trial sites and the IGNITE DMD independent data safety monitoring board; enroll patients in IGNITE DMD; continue to advance SGT-001 in clinical trials; replicate in clinical trials positive results found in preclinical studies and earlier stages of clinical development; advance the development of its product candidates under the timelines it anticipates in current and future clinical trials; successfully optimize and scale its manufacturing process; obtain, maintain or protect intellectual property rights related to its product candidates; compete successfully with other companies that are seeking to develop DMD/Duchenne treatments and gene therapies; manage expenses; and raise the substantial additional capital needed, on the timeline necessary, to continue development of SGT-001, achieve its other business objectives and continue as a going concern. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Company’s actual results to differ from those contained in the forward-looking statements, see the “Risk Factors” section, as well as discussions of potential risks, uncertainties and other important factors, in the Company’s most recent filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company’s views as of the date hereof and should not be relied upon as representing the Company’s views as of any date subsequent to the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so.Investor Contact: David Carey FINN Partners 212-867-1768 David.Carey@finnpartners.comMedia Contact: Erich Sandoval FINN Partners 917-497-2867 Erich.Sandoval@finnpartners.com Solid Biosciences Inc. Condensed Consolidated Statements of Operations (unaudited, in thousands, except share and per share data)                 Three Months Ended September 30, Nine Months Ended September 30,      2020   2019   2020   2019              Revenue $-  $-  $-  $-  Operating expenses:          Research and development  16,045   22,792   49,158   67,671   General and administrative  5,181   6,925   15,957   19,317   Restructuring charges  -   -   1,944   -    Total operating expenses  21,226   29,717   67,059   86,988  Loss from operations  (21,226)  (29,717)  (67,059)  (86,988) Other income (expense):          Interest (expense) income  (20)  406   131   1,281   Other income  -   56   1   345    Total other income (expense), net  (20)  462   132   1,626  Net loss $(21,246) $(29,255) $(66,927) $(85,362) Net loss per share attributable to common stockholders, basic and diluted $(0.44) $(0.67) $(1.39) $(2.26) Weighted average shares of common stock outstanding, basic and diluted  48,295,468   43,467,618   48,172,686   37,727,640          Solid Biosciences Inc. Condensed Consolidated Balance Sheets (unaudited, in thousands, except share and per share data)             September 30, December 31,      2020   2019  Assets     Current assets:      Cash and cash equivalents $24,797  $76,043   Available-for-sale securities  -   7,481   Prepaid expenses and other current assets  2,365   2,778    Total current assets  27,162   86,302  Property and equipment, net  8,869   11,645  Operating lease, right-of-use assets  3,951   4,988  Other non-current assets  209   209  Restricted cash  327   327    Total assets $40,518  $103,471          Liabilities and Stockholders' Equity     Current liabilities:      Accounts payable $4,083  $7,124   Accrued expenses  8,550   9,178   Operating lease liabilities  1,930   1,736   Finance lease liabilities  202   186   Other current liabilities  -   52    Total current liabilities  14,765   18,276   Operating lease liabilities, excluding current portion  2,943   4,414   Finance lease liabilities, excluding current portion  579   733    Total liabilities  18,287   23,423  Common Stock  48   48   Additional paid-in capital  405,389   396,278   Accumulated other comprehensive income  -   1   Accumulated deficit  (383,206)  (316,279)   Total stockholders' equity  22,231   80,048    Total liabilities and stockholders' equity $40,518  $103,471

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  • Solid Biosciences to Host Third Quarter 2020 Financial Results and Business Update Call on November 5, 2020

    CAMBRIDGE, Mass., Nov. 03, 2020 (GLOBE NEWSWIRE) -- Solid Biosciences Inc. (Nasdaq: SLDB), a life sciences company focused on advancing meaningful therapies for Duchenne muscular dystrophy (Duchenne), today announced that it will release third quarter 2020 financial results before the market opens on Thursday, November 5, 2020. Management will host a conference call on the same date beginning at 8:30 a.m. ET to discuss the Company’s financial results and recent business developments. A live webcast of the call will be available on the Company's website at www.solidbio.com under the “News & Events” tab in the Investor Relations section, or by clicking here. Participants may also access the call, by dialing 866-763-0341 for domestic callers or 703-871-3818 for international callers.The archived webcast will be available in the “News and Events” section of the Company's website.About Solid Biosciences Solid Biosciences is a life sciences company focused on advancing transformative treatments to improve the lives of patients living with Duchenne. Disease-focused and founded by a family directly impacted by Duchenne, our mandate is simple yet comprehensive – work to address the disease at its core by correcting the underlying mutation that causes Duchenne with our lead gene therapy candidate, SGT-001. For more information, please visit www.solidbio.com. Investor Contact: David Carey FINN Partners 212-867-1768 David.Carey@finnpartners.comMedia Contact: Erich Sandoval FINN Partners 917-497-2867 Erich.Sandoval@finnpartners.com

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  • Solid Biosciences (SLDB) to PostQ3 Earnings: What's in Store?

    Solid Biosciences (SLDB) will provide updates on its lead pipeline candidate,SGT-001, along with others when it releases third-quarter 2020 results.

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  • Ultragenyx and Solid Biosciences Announce Strategic Collaboration to Develop and Commercialize New Gene Therapies for Duchenne Muscular Dystrophy

    -Collaboration combines Solid’s differentiated microdystrophin construct and Ultragenyx’s HeLa PCL manufacturing platform for use with AAV8 and variants- -Solid receives $40 million upfront via equity investment at a premium; up to $255 million in milestones plus royalty payments--Solid retains exclusive rights to all other uses of its microdystrophins, including its existing SGT-001 program-NOVATO, Calif. and CAMBRIDGE, Mass., Oct. 23, 2020 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (Nasdaq: RARE), a biopharmaceutical company focused on the development and commercialization of novel products for serious rare and ultra-rare diseases, and Solid Biosciences Inc. (Nasdaq: SLDB), a life sciences company focused on advancing meaningful therapies for Duchenne muscular dystrophy (Duchenne), today announced a strategic collaboration and license agreement to focus on the development and commercialization of new gene therapies for Duchenne. The parties will collaborate to develop products that combine Solid’s differentiated microdystrophin construct, Ultragenyx’s HeLa producer cell line (PCL) manufacturing platform, and AAV8 variants. The collaboration also brings together Solid’s expertise in muscle biology and Ultragenyx’s expertise in bringing novel therapies to patients with rare diseases.Under the terms of the collaboration, Solid granted Ultragenyx an exclusive license for any pharmaceutical product that expresses Solid’s proprietary microdystrophin construct from AAV8 and variants thereof in clade E for use in the treatment of Duchenne and other diseases resulting from lack of functional dystrophin, including Becker muscular dystrophy. Ultragenyx has made a $40 million investment in Solid and has agreed to pay up to $255 million in cumulative milestone payments per product upon achievement of specified milestone events, and tiered royalties on worldwide net sales at low double digit to mid-teens percentages. Upon achievement of proof-of-concept, Solid has the right to opt-in to co-fund collaboration programs in return for participation in a profit share or increased royalty payments.“We believe that Solid’s microdystrophin is best-in-class with its unique neuronal nitric oxide synthase binding domain,” said Emil D. Kakkis, MD, PhD, Chief Executive Officer and President of Ultragenyx. “By using an AAV8 variant validated in prior human and other studies combined with our scalable, efficient HeLa producer cell line platform, we believe we can leverage our mutual strengths to develop a high-quality AAV-based treatment alternative for Duchenne.”“Ultragenyx has a demonstrated track record of success in developing and commercializing innovative therapies for rare diseases,” said Ilan Ganot, Co-Founder, President and Chief Executive Officer at Solid Biosciences. “We believe it is the partner of choice for exploring new gene therapy opportunities for patients with Duchenne.”Solid’s proprietary microdystrophin construct has exhibited functional benefit in preclinical models. In preclinical studies, animals expressing a microdystrophin capable of restoring neuronal nitric oxide synthase (nNOS) resisted fatigue better than those expressing a microdystrophin that does not. Patients dosed with Solid’s proprietary microdystrophin construct at the 2E14 vg/kg dose in Solid’s ongoing IGNITE DMD clinical trial have also preliminarily demonstrated nNOS activity and function, further validating these preclinical results. Solid expects to dose the next patient in the IGNITE DMD clinical trial, using SGT-001 produced using its improved HSV manufacturing process, in the first quarter of 2021.Ultragenyx intends to use its AAV-based HeLa PCL platform including HeLa 3.0 improvements for the development of product candidates. The platform enables large 2,000 liter commercial-scale AAV-based gene therapy product manufacturing. The PCL platform yields high-quality product from a highly reproducible, highly scalable, and less expensive process – a distinct vantage in higher dose indications like Duchenne. The capsid planned is an AAV8 variant with a favorable immunological profile that has been used successfully in the large scale 2,000 liter production process.About UltragenyxUltragenyx is a biopharmaceutical company committed to bringing novel products to patients for the treatment of serious rare and ultra-rare genetic diseases. The company has built a diverse portfolio of approved therapies and product candidates aimed at addressing diseases with high unmet medical need and clear biology for treatment, for which there are typically no approved therapies treating the underlying disease.The company is led by a management team experienced in the development and commercialization of rare disease therapeutics. Ultragenyx’s strategy is predicated upon time- and cost-efficient drug development, with the goal of delivering safe and effective therapies to patients with the utmost urgency and ensuring majority access to its therapies for patients who can benefit.Ultragenyx currently has three AAV gene therapies in clinical development, including DTX201 that uses an AAV8 variant in the HeLa PCL platform and that is partnered with Bayer, who has released positive Phase 1/2 data in Hemophilia A. The company’s other clinical AAV8 gene therapies, DTX301 and DTX401, are in Phase 1/2 studies for ornithine transcarbamylase (OTC) deficiency and glycogen storage disease type Ia (GSDIa), respectively. An investigational new drug (IND) application is expected by the end of 2020 for a fourth AAV gene therapy for Wilson disease, which will also use the HeLa PCL AAV manufacturing platform.For more information on Ultragenyx, please visit the company’s website at www.ultragenyx.com.About Solid BiosciencesSolid Biosciences is a life sciences company focused on advancing transformative treatments to improve the lives of patients living with Duchenne. Disease-focused and founded by a family directly impacted by Duchenne, our mandate is simple yet comprehensive – work to address the disease at its core by correcting the underlying mutation that causes Duchenne with our lead gene therapy candidate, SGT-001.Solid’s SGT-001 is a novel adeno-associated viral (AAV) vector-mediated gene transfer therapy designed to address the underlying genetic cause of Duchenne. Duchenne is caused by mutations in the dystrophin gene that result in the absence or near absence of dystrophin protein. SGT-001 is a systemically administered candidate that delivers a synthetic dystrophin gene, called microdystrophin, to the body. This microdystrophin encodes for a functional protein surrogate that is expressed in muscles and stabilizes essential associated proteins, including nNOS. Data from Solid’s preclinical program suggests that SGT-001 has the potential to slow or stop the progression of Duchenne, regardless of genetic mutation or disease stage.SGT-001 is based on pioneering research in dystrophin biology by Dr. Jeffrey Chamberlain of the University of Washington and Dr. Dongsheng Duan of the University of Missouri. SGT-001 has been granted Rare Pediatric Disease Designation, or RPDD, and Fast Track Designation in the United States and Orphan Drug Designations in both the United States and European Union.For more information, please visit www.solidbio.com.Ultragenyx Forward-Looking Statements Except for the historical information contained herein, the matters set forth in this press release, including statements related to Ultragenyx's expectations and projections regarding its future operating results and financial performance, anticipated cost or expense reductions, the timing, progress and plans for its clinical programs and clinical studies, future regulatory interactions, and the components and timing of regulatory submissions are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve substantial risks and uncertainties that could cause our clinical development programs, collaboration with third parties, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the effects from the COVID-19 pandemic on the company’s clinical activities, business and operating results, uncertainty and potential delays related to clinical drug development, smaller than anticipated market opportunities for the company’s products and product candidates, manufacturing risks, competition from other therapies or products, and other matters that could affect sufficiency of existing cash, cash equivalents and short-term investments to fund operations, the company’s future operating results and financial performance, the timing of clinical trial activities and reporting results from same, and the availability or commercial potential of Ultragenyx’s products and drug candidates. Ultragenyx undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Ultragenyx in general, see Ultragenyx's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on July 30, 2020, and its subsequent periodic reports filed with the Securities and Exchange Commission.Solid Biosciences Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding whether the collaboration will yield any viable product candidates, potential milestone payments or royalty payments in connection with the collaboration, the potential benefits of the collaboration, the safety or potential efficacy of SGT-001 and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” “working” and similar expressions. Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. These risks and uncertainties include, but are not limited to, risks associated with each party’s ability to perform its obligations under the collaboration, the Company’s ability to resume and/or continue IGNITE DMD on the timeline expected or at all; obtain and maintain necessary approvals from the FDA and other regulatory authorities; obtain and maintain the necessary approval from investigational review boards at IGNITE DMD clinical trial sites and the IGNITE DMD independent data safety monitoring board; enroll patients in IGNITE DMD; continue to advance SGT-001 in clinical trials; replicate in clinical trials positive results found in preclinical studies and earlier stages of clinical development; advance the development of its product candidates under the timelines it anticipates in current and future clinical trials; successfully optimize and scale its manufacturing process; obtain, maintain or protect intellectual property rights related to its product candidates; compete successfully with other companies that are seeking to develop DMD/Duchenne treatments and gene therapies; manage expenses; and raise the substantial additional capital needed, on the timeline necessary, to continue development of SGT-001, achieve its other business objectives and continue as a going concern. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Company’s actual results to differ from those contained in the forward-looking statements, see the “Risk Factors” section, as well as discussions of potential risks, uncertainties and other important factors, in the Company’s most recent filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company’s views as of the date hereof and should not be relied upon as representing the Company’s views as of any date subsequent to the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so.Contacts:Ultragenyx Joshua Higa (415) 475-6370Solid Biosciences Investor Contact: David Carey FINN Partners 212-867-1768 David.Carey@finnpartners.comMedia Contact: Erich Sandoval FINN Partners 917-497-2867 Erich.Sandoval@finnpartners.com

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  • Do Options Traders Know Something About Solid Biosciences (SLDB) Stock We Don't?

    Investors need to pay close attention to Solid Biosciences (SLDB) stock based on the movements in the options market lately.

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  • Solid Biosciences’ (SLDB) Stock Will Surge Over 200% From Current Levels, Says Analyst

    11 months ago, the U.S. Food and Drug Administration (FDA) shut down Solid Biosciences' (SLDB) "IGNITE DMD" Phase I/II clinical trial after one of the young patients involved in the trial suffered a "serious adverse event." Despite the patient in question recovering, no new patients suffering such serious adverse events, and the company providing the FDA with "information and measures intended to improve patient safety" and "data related to manufacturing process improvements," the FDA declined to allow trials to resume in July, and asked Solid Biosciences to provide even more information on its trials, and on the safety measures it proposed to add to get the trials back on track.Fast forward three more months and -- success!On Thursday, Solid Biosciences confirmed that the FDA has "lifted the clinical hold" on its trials, acknowledging that the company has "satisfactorily addressed all clinical hold questions." Going forward, the company plans to remove most empty viral capsids (the protein shell that contains viral material) and limit the maximum weight of the child-patients entering its trials to 18 kilograms, so as to reduce the viral load of the SGT-001 therapy to which patients are exposed. As the name suggests, Solid Biosciences' IGNITE DMD trials are aimed at slowing or reversing the effects of Duchenne Muscular Dystrophy (DMD), a genetic disease that causes progressive muscle degeneration and weakness mostly in young boys aged two and up (which explains the low maximum weight of trial participants). The company's SGT-001 is a gene therapy that injects a modified virus into a patient, containing DNA coded to fix the problems that cause the disease.At least, this is what should happen in theory. The IGNITE DMD trials are designed to find out if it works in practice, and thanks to the FDA's reconsideration, now these trials will be allowed to resume -- probably in the first quarter of 2021.In a note Thursday, Chardan analyst Gbola Amusa confirmed that the FDA's decision puts development of SGT-001 "back on course" towards addressing a $50 billion global market opportunity. If approved, the treatment will be one of only a "relatively few" gene therapies that have ever been approved for human use globally, putting Solid Biosciences in a leading position in this market. And because gene therapy products such as SGT-001 are considered "novel, complex, and relatively difficult to manufacture," the barriers to entry in this market for competitors would be significant.The analyst views this as a "vast opportunity" -- one not without risks, but one that could, if the treatment proves out, lift Solid Biosciences stock from its present price of $4 and change all the way to $12.50 or more. This new price target, by the way, is more than twice what Amusa valued the company at before the FDA's Thursday decision, and implies 208% upside from current levels. And in fact, Amusa muses that "with progress," the treatment "could take SLDB significantly past our updated price target of $12.50" -- and notes repeatedly that in years past, Solid Biosciences stock even reached "peak highs of >$50/sh," implying that the eventual upside could be even greater than what he's prepared to postulate today. (To watch Amusa's track record, click here)Overall, SLDB holds a Moderate Buy rating from the analyst consensus, based on 2 “buy,” and 1 “hold” ratings. Shares are selling for $4.06, and the average price target of $7.17 implies a 79% upside potential. (See SLDB stock analysis on TipRanks)To find good ideas for healthcare stocks trading at attractive valuations, visit TipRanks’ Best Stocks to Buy, a newly launched tool that unites all of TipRanks’ equity insights.Disclaimer: The opinions expressed in this article are solely those of the featured analysts. The content is intended to be used for informational purposes only. It is very important to do your own analysis before making any investment.

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  • Solid Biosciences to Participate in Virtual Fireside Chat at the Chardan 4th Annual Genetic Medicines Conference

    CAMBRIDGE, Mass., Oct. 02, 2020 (GLOBE NEWSWIRE) -- Solid Biosciences Inc. (Nasdaq: SLDB), a life sciences company focused on advancing meaningful therapies for Duchenne muscular dystrophy (Duchenne), today announced that Jennifer Ziolkowski, Chief Financial Officer, Joel Schneider, Chief Technology Officer and Cathryn Clary, Interim Chief Medical Officer, will participate in a virtual fireside chat at the Chardan 4th Annual Genetic Medicines Conference on Tuesday, October 6, 2020 at 4:45 pm ET. A live webcast of the fireside chat will be available on the Events page of the Investors section of the Company website or by clicking here. A webcast replay will be archived for approximately 30 days on the Events page.About Solid Biosciences Solid Biosciences is a life sciences company focused on advancing transformative treatments to improve the lives of patients living with Duchenne. Disease-focused and founded by a family directly impacted by Duchenne, our mandate is simple yet comprehensive – work to address the disease at its core by correcting the underlying mutation that causes Duchenne with our lead gene therapy candidate, SGT-001. For more information, please visit www.solidbio.com.Investor Contact: David Carey FINN Partners 212-867-1768 David.Carey@finnpartners.comMedia Contact: Erich Sandoval FINN Partners 917-497-2867 Erich.Sandoval@finnpartners.com

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  • Why Solid Biosciences Stock Is Trading Higher Today

    Solid Biosciences (NASDAQ: SLDB) shares are trading higher on Thursday after the company announced the FDA has lifted the clinical hold placed on the company's IGNITE DMD Phase 1/2 clinical trial.Solid Biosciences is a life science company. It is engaged in manufacturing of specialty and generic drugs. The company is involved in curing Duchenne muscular dystrophy (DMD), a genetic muscle-wasting disease predominantly affecting boys, with symptoms that usually manifest between three and five years of age.Its lead product candidate, the SGT-001, is a gene transfer under development to restore functional dystrophin protein expression in patients' muscles. The company's pipeline products are the SB-001 and solid suit. The company has categorized its programs into corrective therapies, disease-modifying therapies, and assistive devices. In the assistive device program, the company focuses on producing a wearable assistive device for patients with DMD.Solid Biosciences shares traded up 121.67% to $4.50 on Thursday. The stock has a 52-week high of $13.58 and a 52-week low of $1.93.> $SLDB Solid Biosciences Inc +140% Move Of The Day | Benzinga Pro Alert https://t.co/km5ZOt4CHU via @YouTube> > -- Benzinga (@Benzinga) October 1, 2020See more from Benzinga * Options Trades For This Crazy Market: Get Benzinga Options to Follow High-Conviction Trade Ideas * Why STMicroelectronics Stock Is Trading Higher Today * Why Nano Dimension's Stock Is Trading Lower Today(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

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