SPRO Earnings Date and Information. Oops! In this article, I will focus in particular on the deal with GSK and the associated impact on Spero's financial position (among other things, due to Seeking Alpha's guidelines regarding the Microcap Coverage Policy. Event is taking place on Thursday, October 6 th at 11:30 a.m. View Contact Info for Free. Last but not least, Spero is entitled to sales milestone payments and royalties. Year to date through June 30, the S&P 1500 Biotech Index was down 1.6%, vs. a 20.5% decline for the S&P 1500 Composite Index. Spero Therapeutics, Inc. 675 Massachusetts Avenue, 14th Floor . Changes in these assumptions may have a material impact on the backtested returns presented. Tebipenem HBr has a clear US FDA regulatory path to potential approval, which could significantly benefit patients with complicated urinary tract infections., Speros agreement with GSK provides a critical step towards fully realising the value tebipenem HBr can potentially provide to physicians, payors, and patients, said Ankit Mahadevia, M.D., Chief Executive Officer of Spero. It focuses on identifying, developing and commercializing novel treatments for MDR (Multi-drug-resistant) bacterial infections and rare diseases. In my opinion, this fact reflects Spero's deep belief in its pipeline and capabilities. In short, Spero screwed up on its approval and commercialization strategy and found itself in a lousy position following the FDA's CRL. s***@sperotherapeutics.com. Wolf Haldenstein Adler Freeman & Herz LLP. Nevertheless, I am convinced that these assets can create massive shareholder value. ITEM 2. Novel Treatment Development For Multi-Drug - Spero Therapeutics As already mentioned, I do not value the other assets in Spero's pipeline for my NPV calculation. Spero Therapeutics Inc reported an EPS of -$0.25 in its last earnings report, beating expectations of -$0.333. Spero Therapeutics also has an IV-administered next-generation polymyxin product candidate, SPR206, developed from its potentiator platform, which is in development to treat multi-drug resistant Gram-negative infections in the hospital setting. Biopharmaceutical Jobs at Spero Therapeutics Since sales milestone payments are subject to a high degree of uncertainty and remain in the long term, I currently only want to mention them as a potential, but do not want to include them in the calculation. First interim results are expected in mid-2023. This information is provided for illustrative purposes only. an actively managed portfolio, Cash from Operations Ann'l Positive Last 5 yrs. SPERO THERAPEUTICS Following the footsteps of the first phase 3 trial with Tebipenem HBr, I expect results to be published within roughly 15 months. Read More. For more information: The design of this milestone is very similar to the design of the milestone regarding SPR206 with Everest Medicines. On April 6, 2022, Spero Therapeutics announced publication in the New England Journal of Medicine (NEJM) the results from the Phase 3 ADAPT-PO clinical trial for its investigational oral carbapenem antibiotic, tebipenem pivoxil hydrobromide (tebipenem HBr). Following feedback from the US FDA at Speros recent Type A meeting, Spero will conduct an additional phase III trial to support the regulatory submission. Carl Swanson is a Medical Information & Governance Lead at Spero Therapeutics based in Cambridge, Massachusetts. Finally, I want to briefly explain why Spero hammered this deal. Companies similar to Spero Therapeutics Inc in the Biotechnology & Medical Research industry. Dr. Melnick has 18 years of experience in anti-infective drug development. For more information about In the following article, I will analyze whether the share price surge is justified and derive a fair value for Spero. We are a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. The 12-month stock price forecast is $7.0, which is an increase of 363.58% from the latest price. The transactions are expected to close in the fourth quarter of 2022, subject to customary closing conditions, including the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended. For more information, visit https://www.sperotherapeutics.com. Learn more about whether Spero Therapeutics Inc is a good stock to buy or sell based on recent news as well as its key financial metrics. This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules. The deal is fundamental for my investment thesis. Nevertheless, I believe that this milestone payment is very likely to occur. AAIIs stock screen that follows the companies with the highest earnings estimate revisions (i.e., the best grades) has a 23.3% backtested annual return since inception, whereas an example screen following those with the worst revisions has a backtested annual return since inception of under 5%. Edwin Sopp is a Head of Quality Assurance at Spero Therapeutics based in Cambridge, Massachusetts. In general, it should be noted that most institutional investors bought their shares at significantly higher prices. Then on May 3, 2022, Spero issued a press release announcing that it will immediately defer current commercialization activities for tebipenem HBr based on feedback from a recent Late Cycle Meeting with the U.S. Food and Drug Administration (FDA) regarding Speros New Drug Application (NDA) for tebipenem HBr[,] and that, [a]lthough the review is still ongoing and the FDA has not yet made any final determination regarding approvability, the discussion suggested that the data package may be insufficient to support approval during this review cycle. Specifically, the FDA advised the Company, in relevant part, that the FDAs separate analysis of the relevant study population had reduce[d] the number of evaluable patients in the primary analysis population compared with those resulting from the trials pre-specified micro-ITT population as outlined in the statistical analysis plan and [a]s a result, the FDA considers that the pre-specified non-inferiority margin of -12.5% was not met. Further, the press release advised that, [i]n connection with this development, Spero announced that it is undertaking a reduction in its workforce by approximately 75% and a restructuring of its operations to reduce operating costs and reallocate resources.. Logo of Spero Therapeutics (Source: Company Homepage), It is our mission to bring hope to patients and families of loved ones suffering from serious infections. The deal includes highly attractive milestone payments, which are very special as they are only partly dependent on the future success of tebipenem HBr. Heather Smotrich is a Senior Accountant at Spero Therapeutics based in Cambridge, Massachusetts. Overall, the disease affects 95,000 patients in the U.S. and a total of 245,000 in the U.S., Europe, and Japan, with 75% of all NTM patients being non-refractory and representing the target population of SPR720. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: On March 31, 2022, Spero issued a press release announcing the Companys fourth quarter and full year 2021 financial results. WebThe Latest. GSK plc (LSE/NYSE: GSK) and Spero Therapeutics, Inc. (Nasdaq: SPRO) today announced they have entered into an exclusive licence agreement for tebipenem pivoxil hydrobromide (tebipenem HBr), a late-stage antibiotic being developed by Spero, as the first oral carbapenem antibiotic to potentially treat complicated urinary tract infections (cUTI), including pyelonephritis, caused by certain bacteria. SPERO THERAPEUTICS, INC. CLASS ACTION ALERT: Wolf Spero Total commercial milestone payments based on first sale (US/EU). Entering text into the input field will update the search result below. As early as the fourth quarter of 2022, Spero plans to initiate a phase 2 proof-of-concept study with the objective to show an early microbiological response in the 35 enrolled patients. The deal is expected to close in the coming weeks, subject to customary closing conditions. For refractory patients, there is an approved product with limited therapeutic benefit, Insmed's (INSM) Arikayce. Spero Therapeutics Inc - Company Profile and News Web Spero Therapeutics offers a competitive benefits package that includes: Medical, Dental and Vision Insurance Coverage Life and AD&D Coverage Short- and Long-Term Disability The company focuses on treatments with a novel therapeutic approach to treat multi-drug resistant and life-threatening bacterial infections and rare diseases. Even in the worst-case scenario, meaning disappointing Phase 3 data and a discontinuation of the program, I end up with a fair NPV of $2.55, which is an upside of 27.5% based on today's prices. In some cases, forward-looking statements can be identified by terms such as may, will, should, expect, plan, aim, anticipate, could, intent, target, project, contemplate, believe, estimate, predict, potential or continue or the negative of these terms or other similar expressions. CAMBRIDGE, Mass., June 30, 2023 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc.(Nasdaq: SPRO), a multi-asset clinical-stage biopharmaceutical company, focused on identifying, developing and commercializ Sath Shukla, current Spero Chief Financial Officer, will bring more than 20 years of strategic and financial leadership to the role of CEO, to be effective August 1, 2023, Phase 2 trial of SPR720 in nontuberculous mycobacterial pulmonary disease (NTM-PD) on track for top line data readout in 1H 2024. General assumptions include: XYZ firm would have been able to purchase the securities recommended by the model and the markets were sufficiently liquid to permit all trading. No representations and warranties are made as to the reasonableness of the assumptions. Typically, AAII looks at the weighted relative strength over the trailing four quarters. utah778 via Getty Images Dive Brief: Antibiotics developer Spero Therapeutics is laying off 75% of its workforce, including two top executives, after the Food and Drug Target patient population (Source: Company Presentation). Nonetheless, in this section I would like to specifically address potential risks. Something went wrong while submitting the form. GSK will receive an exclusive licence to develop and commercialise tebipenem pivoxil HBr in all countries except Japan and certain other Asian countries that Spero partner Meiji Seika will retain. LifeSci Advisors . The deal with GSK partially confirms these assumptions. Luke Miels, Chief Commercial Officer, GSK, said: There is a high unmet medical need for a novel oral antibiotic as an alternative to intravenous hospital therapy for drug-resistant complicated urinary tract infections. As you can see, Spero Therapeutics Inc stock is performing better in 1 than its top five competitors. In anticipation of approval of its lead asset, Tebipenem HBr, Spero began ramping up commercial activities for the US market earlier this year. The company's product candidates include tebipenem pivoxil hydrobromide (HBr), an oral carbapenem-class antibiotic to treat complicated urinary tract infections, including pyelonephritis for adults; SPR206, a direct acting IV-administered agent to treat MDR Gram-negative bacterial infections in the hospital; and SPR720, Spero Therapeutics, Inc. is a clinical-stage biopharmaceutical company which focuses on identifying, developing, and commercializing novel treatments for multi-drug resistant, or MDR, bacterial infections. Spero Therapeutics, Inc.s 2017 Stock Incentive Plan . GSK and Spero Therapeutics announce exclusive licence 2023 Stock Analysis. The deal was very positively received by the market and the share price tripled at its peak within a very short period of time. While topline data will not be available until early 2024, analysis of interim data in mid-2023 could provide early evidence of SPR720's efficacy. Spero Therapeutics, Inc. (SPRO) came out with quarterly earnings of $0.55 per share, beating the Zacks Consensus Estimate of a loss of $0.40 per share. WebSpero Therapeutics | 12,686 followers on LinkedIn. Learn more about him: bit.ly/3DpdTBQ. Myriah Satterfield is an Associate Director, Clinical Data Management at Spero Therapeutics based in Cambridge, Massachusetts. Access the contact details of our media relations teams at GSK. Policy Regarding Security Holder Communications, Nominating And Corporate Governance Committee. purpose of assisting individuals in becoming effective managers of their own assets through programs of If you have incurred losses in Spero Therapeutics, Inc., you may, no later than July 25, 2022, request that the Court appoint you lead plaintiff of the proposed class. AAIIs A+ Investor Quality Grade comes from the ranking of key metrics. View Contact Info for Free Accordingly, this milestone should be achieved by the end of 2024. The FDAs heavy focus on COVID-19 could slow the approvals on non-COVID-19 therapies. 2001-2023 GSK plc. Spero Therapeutics Inc. Spero Therapeutics, Inc. is a clinical-stage biopharmaceutical company which focuses on identifying, developing, and commercializing novel treatments for multi-drug resistant, or MDR, bacterial infections. Spero Therapeutics Announces $40 Million Equity Spero Therapeutics | LinkedIn Spero to lay off 75% of workforce, change strategy after FDA received by the market and the share price tripled at its peak within a very short period of time. In June 2022, the FDA communicated that it had completed its review of the NDA and On this news, Speros stock price fell $1.59 per share, or 18.27%, to close at $7.11 per share on April 1, 2022. Learn more about A+ Investor here! What is Spero Therapeutics Incs EPS estimate? Chief Medical Officer. Spero expects to initiate the follow-up Phase 3 trial in 2023 after final alignment with the FDA. If Tebipenem is approved, GSK has invested $375 million in the deal, excluding commercialization costs. AAII can help you figure out both and identify which investments align with what works best for you. The firm has attorneys in various practice areas; and offices in New York, Chicago and San Diego. Spero Therapeutics Provision of unlicensed medicines for unmet medical needs, Chemical Manufacturing and Controls (CMC), Medicine Development and Supply (MDS), Work experience, placements and internships, Manufacturing Operations, Quality & Logistics, Fraudulent internet recruitment activities. Spero Therapeutics is a multi-asset, clinical-stage biopharmaceutical company focused on identifying, developing, and commercializing novel treatments for bacterial infections, including multi-drug resistant bacterial infections and rare diseases. Get stock ideas inspired by the market's leading Spero Therapeutics Inc has a Momentum Score of 94, which is Very Strong. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including Speros and GSKs ability to obtain antitrust clearance and close the proposed transactions in a timely manner; whether tebipenem HBr will advance through the clinical trial process on a timely basis, or at all, taking into account the effects of possible regulatory delays, slower than anticipated patient enrollment, manufacturing challenges, clinical trial design and clinical outcomes; whether the results of such trials will warrant submission for approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies; whether the FDA will ultimately approve tebipenem HBr and, if so, the timing of any such approval; whether the FDA will require any additional clinical data or place labeling restrictions on the use of tebipenem HBr that would delay approval and/or reduce the commercial prospects of tebipenem HBr; whether a successful commercial launch can be achieved and market acceptance of tebipenem HBr can be established; and other factors discussed in the Risk Factors set forth in filings that Spero periodically makes with the U.S. Securities and Exchange Commission. CAMBRIDGE, Mass., June 30, 2021 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO) a multi-asset clinical-stage biopharmaceutical
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