View Contact Info for Free. This press release may contain forward-looking statements. Following the earnings report the stock price went down -3.646%. Tebipenem HBr complements GSKs infectious disease strategy and is consistent with our commitment to find value-enhancing opportunities to build a strong late-stage portfolio. Overall, tebipenem HBr is patent-protected until 2038. 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. If approved, Spero could have accessed additional non-dilutive capital or negotiated from a position of strength and start with the commercialization. In the following, I want to give an overview of the pipeline and upcoming milestones. I believe that these are passed on directly to Meiji Pharma, in particular at the beginning of sales activities. These statements include, but are not limited to, statements about the timing of the closing of the license and equity investment transactions, the regulatory path forward for tebipenem HBr and potential FDA approval, the potential commercialization of tebipenem HBr and its future value, and the potential receipt of milestone payments, and royalties on future sales under the license agreement. SPR206 is a novel intravenous antibiotic for the treatment of multidrug-resistant bacterial infections. Drug sales are anticipated to have high growth, primarily driven by COVID-19 therapeutics, the continued adoption of many new and innovative therapies, a favorable M&A environment, and a low prevalence of patent expirations in 2022. To ensure this doesnt happen in the future, please enable Javascript and cookies in your browser. 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 most recent quarterly price change is given a weight of 40% and each of the three previous quarters are given a weighting of 20%. For more information about Spero Therapeutics Inc has a Momentum Score of 94, which is Very Strong. No cash balance or cash flow is included in the calculation. 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. Therefore, it is not surprising that Spero sees blockbuster potential in Tebipenem HBr despite being the second line treatment and compares it with Zyvox sold by Pfizer (PFE) with peak sales of $1.4 billion. Cambridge, Massachusetts 02139 (Name and address of agent of service) (857) 242-1600 It is noteworthy that the renowned BVF, for example, almost doubled its share in the last quarter and thus possibly after the Spero's announcement of a strategic realignment. Thus, however, partnering the asset was the only way to protect shareholder value from massive dilution or expropriation as more capita was needed to initiate the required Phase 3 study. Overall, Spero is keeping very tight-lipped about the composition of these milestone payments, but generally speaking, these milestone payments compensate Spero for the costs associated with the Phase 3 trial. WebSPERO THERAPEUTICS, INC. 2017 STOCK INCENTIVE PLAN, AS AMENDED (Full title of the plan) Ankit Mahadevia, M.D., Chief Executive Officer and President . The weighted four-quarter relative strength rank is the relative price change for each of the past four quarters. Under the terms of the licence agreement, GSK will make an upfront initial payment to Spero of $66 million to secure rights to the medicine. The current cash balance even exceeds the current market capitalization of $95 million, resulting in a negative pipeline value of $20 million. SPR720 has potential to be the first approved novel oral agent for What was Spero Therapeutics Incs price range in the past 12 months? Tamara Joseph. Mergers and acquisitions activity is expected to remain low as a more activist Federal Trade Commission (led by Lina Khan) could be more skeptical of proposed mergers. In addition to Value, Momentum and Growth, A+ Investor also provides grades for Estimate Revisions and Quality. Tebipenem HBr is an investigational drug in the United States being developed for the treatment of cUTI, including pyelonephritis, caused by certain bacteria, in adult patients with limited treatment options; tebipenem HBr is not FDA-approved. In most cases, people with a weak immune systems or damaged lungs are more likely to be affected. More interesting is the fact that GSK did not simply buy out the company; after all, Spero's market cap was only $30 million (before the deal). Instead of working on several processes in parallel, as is often the case, a sequential order is adopted here. All rights reserved. Backtested results are adjusted to reflect the reinvestment of dividends and other income and, except where otherwise indicated, are presented gross-of fees and do not include the effect of backtested transaction costs, management fees, performance fees or expenses, if applicable. Spero was In my opinion, the example of Spero Therapeutics is a very good example of how irrational biotech stocks are currently valued by the market. Which hedge fund is a major shareholder of Spero Therapeutics Inc? Spero Therapeutics last issued its quarterly earnings results on May 11th, 2023. Momentum is based on the price change of a stock over a specified period relative to all other stocks. Nontuberculous Mycobacteria (NTM) Infections, Learn more about Tebipenem HBr and our other candidates. On this news, Speros stock price fell $3.24 per share, or 63.65%, to close at $1.85 per share on May 3, 2022. WebOverview Company Description: Key Principal: Ankit Mahadevia See more contacts Industry: Pharmaceutical preparations Printer Friendly View Address: 675 Massachusetts Ave Ste 14 Accordingly, this milestone should be achieved by the end of 2024. For more information, visit https://www.sperotherapeutics.com. Chemical Formula: C22H32BrN3O36S2Molecular Weight: 578.54g/mol. Spero expects the deal to be approved and closed in the fourth quarter of 2022. Spero Therapeutics Inc has a Growth Score of 44, which is Average. The exact milestone structure has not been disclosed. Entering text into the input field will update the search result below. Under the licence agreement, Spero will be responsible for the execution and costs of the remaining phase III clinical trial of tebipenem HBr. Spero has received the Type A meeting minutes and proposed regulatory guidance regarding additional clinical study. 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. The American Association of Individual Investors is an independent, nonprofit corporation formed 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. The interesting thing about this milestone: it's not linked to the success of a clinical trial and therefore, it will certainly be achieved. From this date, GSK will be responsible for regulatory approval and commercialization activities. Dr. Melnick has 18 years of experience in anti-infective drug development. The agreement grants GSK worldwide rights for the development and commercialization of Tebipenem HBr except for certain territories in Asia. Spero Therapeutics Tebipenem HBrs potential as an at-home, oral option can potentially be of significant benefit by reducing hospital resource utilisation. Changes in these assumptions may have a material impact on the backtested returns presented. Nevertheless, I believe that this milestone payment is very likely to occur. SPERO THERAPEUTICS, INC. CLASS ACTION ALERT: Wolf The estimation of a probability is of course always subjective, but for the calculation I personally assume a conservative 60% probability of an approval success. I assign a value of $75 million, which is about $1.60 per share. WebSPERO THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 46-4590683 State or other jurisdiction of incorporation or organization (I.R.S. No recommendation or advice is being given as to whether any investment is suitable for a particular investor. In order to compute the Growth Score and assign it a letter grade, the percentile ranks for each of the three individual componentsconsistency of annual sales growth, five-year sales growth rankings adjusted for extreme levels, and consistency of positive annual cash from operationsmust be determined. For more information: The design of this milestone is very similar to the design of the milestone regarding SPR206 with Everest Medicines. The deal with GSK partially confirms these assumptions. In my opinion, this fact reflects Spero's deep belief in its pipeline and capabilities. The deal confirms that tebipenem HBr is a real drug with both a clear therapeutic and economic benefit and can reach sales of up to $1 billion. Tebipenem HBr remains an important part of the Spero pipeline and a complement to our SPR720 and SPR206 programs, which we continue to advance towards key clinical and regulatory milestones.Ankit Mahadevia, M.D.,Chief Executive Officer of Spero Therapeutics. Last but not least, Spero is entitled to sales milestone payments and royalties. 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. The deal includes highly attractive milestone payments, which are very special as they are only partly dependent on the future success of tebipenem HBr. SPR720, in-licensed from Vertex (VRTX), is an orally administered antibiotic for the treatment of non-tuberculous mycobacteria (NTM). The commercial milestone of $150 million is discounted (from Q4 2025 to Q4 2022) at an interest rate of 12%. Spero Therapeutics Inc - Company Profile and News SPRO Earnings this Week: How Will it Perform? Year-over-year quarterly sales growth most recently was 0.0%. Oops! The company focuses on treatments with a novel therapeutic approach to treat multi-drug resistant and life-threatening bacterial infections and rare diseases. the data submitted in support of the Tebipenem HBr NDA were insufficient to obtain FDA approval; it was unlikely that the FDA would approve the Tebipenem HBr NDA in its current form; and. Spero Therapeutics 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).In June 2022, the FDA communicated that it had completed its review of the NDA and determined that the NDA could not be approved in its present form. Simply summarized, the primary endpoint of statistical non-inferiority was met. 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). Due to this, repeat vaccinations will likely be necessary for lifelong immunity which would provide a long-lasting and significant source of revenue for lead vaccine developers. Collaborative. Since trades have not actually been executed, results may have under- or over-compensated for the impact, if any, of certain market factors, such as lack of liquidity, and may not reflect the impact that certain economic or market factors may have had on the decision-making process. These forward-looking statements should not be relied upon as representing Speros views as of any date subsequent to the date of this press release. I assign a value of $0. GSK will be responsible for the execution and costs of additional clinical development, including regulatory submission and commercialisation activities for tebipenem HBr in the countries mentioned above. 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. 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. Medical Consultant at Spero Therapeutics . The $150 million non-performance related milestone payment, equivalent to $3.2 per share, associated with Phase 3 clinical trial provides sufficient upside from today's share price. In the coming weeks, the market will have to understand that the high price surge due to the GSK deal is more than justified. These three rank figures are added together, and the sum is ranked against the entire stock universe to arrive at a companys Growth Score to create an equal distribution of grades. On the one hand, the enormous surge in market capitalization shows very clearly how undervalued Spero Therapeutics was before the deal was announced. CAMBRIDGE, Mass., June 30, 2021 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO) a multi-asset clinical-stage biopharmaceutical Nonetheless, I want to give an overview of the 5 largest Institutional Holders, holding a combined stake of over 30% of Spero. Spero Therapeutics Inc released its earnings results on May 11, 2023. Get stock ideas inspired by the market's leading In general, it should be noted that most institutional investors bought their shares at significantly higher prices. WebAn Oral Antibiotic Designed to Treat Nontuberculous Mycobacterial Pulmonary Disease, a Rare Orphan Disease. Trade marks are owned by or licensed to the GSK group of companies. The company reported -$0.25 earnings per share for the quarter, beating the consensus estimate of -$0.333 by $0.083. Search and download images and B-roll video for use in the media. Consequently, current prices represent an excellent risk-reward ratio. Most notably, this is related to Spero's strategy of actively leveraging business development activities to advance its assets. Stocks with a Value Score from 81 to 100 are considered deep value, those with a score between 61 and 80 are a good value and so on. Furthermore, the FDA has already communicated that a confirmatory study is sufficient for approval. Spero Therapeutics Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4), Spero Therapeutics Appoints Sath Shukla as President & Chief Executive Officer, Spero Therapeutics Announces First Quarter 2023 Operating Results and Provides a Business Update, Spero Therapeutics to Provide Business Update and Report First Quarter 2023 Financial Results on Thursday, May 11, 2023, Spero Therapeutics to Present at Upcoming Investor Conference, Spero Therapeutics to Present Data at the 33rd European Congress of Clinical Microbiology and Infectious Diseases, Spero Therapeutics Announces Fourth Quarter and Full Year 2022 Operating Results and Provides Business Update, Spero Therapeutics Reschedules Fourth Quarter and Full Year 2022 Earnings Release and Conference Call to March 30, 2023, Spero Therapeutics to Provide Business Update and Report Fourth Quarter and Full Year 2022 Financial Results on Monday, March 13, 2023, Spero Therapeutics to Present at Upcoming Investor Conferences, Spero Therapeutics to Present at the 5th Annual Evercore ISI HealthCONx Conference, Spero Therapeutics Announces Third Quarter 2022 Operating Results and Provides Business Update, Spero Therapeutics Announces Closing of Exclusive License Agreement with GSK for Tebipenem HBr, Spero Therapeutics to Provide Business Update and Report Third Quarter 2022 Financial Results on Monday, November 14, 2022, Spero Therapeutics to Present Data at IDWeek 2022, Spero Therapeutics to Host Virtual R&D Event on Non-Tuberculous Mycobacterial Pulmonary Disease and the SPR720 Program, Spero's stock jumps 188% after GSK licenses experimental antibiotic, GSK and Spero Therapeutics Announce Exclusive License Agreement for Late-Stage Antibiotic Asset, Tebipenem HBr, Spero Therapeutics Announces Appointment of Kamal Hamed, MD, MPH, MBA, as Chief Medical Officer, Spero Therapeutics Provides Tebipenem HBr Program Update Following Type A Meeting with the U.S. Food and Drug Administration, Spero Therapeutics Announces Second Quarter 2022 Operating Results and Provides Business Update, Spero Therapeutics to Provide Business Update and Report Second Quarter 2022 Financial Results on Wednesday, August 10, 2022, SHAREHOLDER ALERT FILING DEADLINE TODAY: Pomerantz Law Firm Reminds Shareholders with Losses on their Investment in Spero Therapeutics, Inc. of Class Action Lawsuit and Upcoming Deadline - SPRO, SPRO FINAL DEADLINE TODAY: ROSEN, A GLOBALLY RECOGNIZED FIRM, Encourages Spero Therapeutics, Inc. Investors with Losses to Secure Counsel Before Important July 25 Deadline in Securities Class Action - SPRO, Bronstein, Gewirtz & Grossman, LLC Reminds Spero Therapeutics, Inc. (SPRO)Shareholders of Class Action Deadline and Last Few Hours to Actively Participate. Although I did not include Spero's pipeline in my price target, negative interim study results may negatively impact the share price in mid-2023. How were Spero Therapeutics Incs earnings last quarter? The deal is expected to close in the coming weeks, subject to customary closing conditions. GSK has been developing and supplying antibiotics for more than 70 years. Committed. investment ideas, Full access to all of AAII's model portfolios and premium services at a significant discount, Newsletter and model portfolio that focuses on dividend Due to its small market capitalization of about $100 million, Spero's share price can be more easily influenced by speculators. stock screens, Full access to AAII.com, Journal, and a power data suite for In short, Spero screwed up on its approval and commercialization strategy and found itself in a lousy position following the FDA's CRL. Found email listings include: @ sperotherapeutics.com. Spero Therapeutics | LinkedIn Spero Therapeutics Inc has a Value Score of 58, which is Average. Thank you! Spero Therapeutics The 12-month stock price forecast is $7.0, which is an increase of 363.58% from the latest price. growth. Spero Therapeutics is developing SPR720 as a novel oral therapy candidate for the treatment of a rare, orphan pulmonary disease caused by non-tuberculous mycobacterial infections. Certain assumptions have been made for modeling purposes and are unlikely to be realized. Is this happening to you frequently? You shaved at least $4 off valuation using a ridiculous dcf. The TipRanks Smart Score performance is based on backtested results. The study results show that oral administration of Tebipenem HBr was equally effective and safe compared to the intravenous administration of ertapenem. WebView the latest Spero Therapeutics Inc. (SPRO) stock price, news, historical charts, analyst ratings and financial information from WSJ. View Contact Info for Free Spero Therapeutics, headquartered in Cambridge, Massachusetts, is a multi-asset, clinical-stage biopharmaceutical company Financial Overview of Spero Therapeutics (Source: Author's Chart). Multi-Asset, clinical-stage biotech company focused on multidrug-resistant bacterial infections and rare disease | We are a Spero Therapeutics is developing a novel oral agent to treat these resistant bacteria.On April 6, 2022, the results from the Phase 3 ADAPT-PO clinical trial for its investigational oral carbapenem antibiotic, tebipenem HBr, were published in the New England Journal of Medicine (NEJM). Spero Therapeutics to Provide Business Update and Report First Quarter 2023 Financial Results on Thursday, May 11, 2023, Financial and accounting risks. These milestones have the potential to boost Spero's market capitalization from current levels. Summarizing the deal with GSK (Source: Company Presentation). Hey there, I would like to encourage you to follow me and read my articles for stocks with an excellent risk-reward profile. Source: Company Homepage. Spero Therapeutics purpose of assisting individuals in becoming effective managers of their own assets through programs of Antibiotic Pipeline To Combat Gram-Negative - Spero Therapeutics Select tebipenem HBr trials have been funded in part with federal funds from the Department of Health and Human Services; Office of the Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under contract number HHSO100201800015C. SPR206 is being developed with the goal of providing an effective and safe treatment alternative. TipRanks is a comprehensive research tool that helps investors make better, data-driven investment decisions. Cambridge, Massachusetts 02139 (Name and address of agent of service) (857) 242-1600 Susannah Walpole is a Head Vice President, Clinical Operations at Spero Therapeutics based in Cambridge, Massachusetts. NTM Info & Research is a 501(c)(3) non-profit organization formed for patient support, medical education and to help accelerate research. AAII can help you figure out both and identify which investments align with what works best for you. According to Wall Street analysts Spero Therapeutics Incs price is currently Overvalued. In late June 2022, the FDA issued a Complete Response Letter for the tebipenem HBr NDA, where the FDA concluded that Speros Phase 3 cUTI clinical trial of tebipenem HBr (ADAPT-PO) was insufficient to support approval and that additional clinical study would be required. Head of Quality Assurance at Spero Therapeutics . Aside from vaccines, the biotech industry is dependent on the volume of new therapy approvals. Spero Therapeutics Inc does not currently pay dividends. Previously, Carl was a Medical In formation Consultant at Medical Information Consulting & Pharmacy Services and also held positions at Intarcia Therapeutics, AVEO Pharmaceuticals, EMD Serono, Elan, Pfizer, Join thousands of A+ Investor subscribers and get in-depth stock research and tools to make smarter investment decisions. Head Vice President, Clinical Operations at Spero Therapeutics. Overall, the carbapenem market is estimated to reach $3 billion in the United States alone. Spero Therapeutics Spero to lay off 75% of workforce, change strategy after FDA 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. Led by an executive team with deep experience and world-class scientific talent, Spero is dedicated to delivering differentiated medicines that help patients suffering from serious and life-threatening infections. report analyzing the tech stocks Marvin Cohen works at Spero Therapeutics, which is a Research & Development company with an estimated 35 employees. The firm has attorneys in various practice areas; and offices in New York, Chicago and San Diego. May 31, 2022 15:41 ET Spero Therapeutics Announces $40 Million Equity Investment In the following article, I will analyze whether the share price surge is justified and derive a fair value for Spero. | Source: 99.1 To estimate the peak sales potential, I will refer to information provided by the company and management. GSK is already a leader on the Antimicrobial Resistance Benchmark of the Access to Medicine Foundation and participates in the AMR Action Fund, which aims to bring2-4 new antibioticsto patientsby 2030 through sustainable investment in the antibiotic pipeline. Access to Journal, Shadow Stock portfolio & monthly updates for Spero Therapeutics (NASDAQ:SPRO) surprised its shareholders last week with a deal with GlaxoSmithKline (GSK) that secures the future and development of its most advanced asset, Tebipenem HBr. Registered office: 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom. However, I could imagine evaluating the potential of the pipeline beyond Tebipenem HBr in further articles. Partners - Spero Therapeutics Spero Therapeutics 2023 American Association of Individual Investors. WebPAVmed staves off Nasdaq delisting as net loss widens and stock remains well below $1 threshold. Jon Bruss is a Medical Consultant at Spero Therapeutics based in Cambridge, Massachusetts. SPRO Earnings Date and Information. 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. Overall, external funding and partnerships validate the potential of SPR206. 7/14/2023 2:50 PM. Therefore, I have to mention that the deal is still pending. Something went wrong while submitting the form. Here, well take a closer look at Spero Therapeutics Incs stock grades for value, growth and quality. Spero expects to initiate the follow-up Phase 3 trial in 2023 after final alignment with the FDA. Remaining potential payments are milestone-based, as follows. Due to the ongoing significant undervaluation, the shares have an excellent risk-reward ratio for new investors. Read More. In this way, individuals can effectively become managers of their own assetswithout having to rely on others for financial independence. WebAbout Spero Therapeutics . Prior to joining Spero Therapeutics, Dr. Melnick served as Vice President of Clinical Development for Anti-Infectives at Allergan since 2015. If Tebipenem is approved, GSK has invested $375 million in the deal, excluding commercialization costs. While the deal relieves Spero from this troublesome situation, GSK benefits in acquiring an attractive asset at an reasonable price. SPRO - Spero Therapeutics Inc Stock Price Quote - Morningstar 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.