Get your free copy of our special 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. You can count on AAII for timeless articles on financial planning and stock-picking, unbiased research and actionable analysis. In September 2020, Spero announced positive top-line results from its Phase 3 ADAPT-PO clinical trial of tebipenem HBr in cUTI and AP.Additionally, Spero has an IV-administered next generation polymyxin product candidate, SPR206, developed from its potentiator platform, which is being developed to treat MDR Gram-negative infections in the hospital setting. Overall, external funding and partnerships validate the potential of SPR206. Furthermore, the FDA has already communicated that a confirmatory study is sufficient for approval. In my opinion, this fact reflects Spero's deep belief in its pipeline and capabilities.
I assign a value of $0. Antibiotic resistance is a growing global health threat, and one especially troubling concern is the rise in resistant strains of E. coli, the bacteria that cause the majority of urinary tract infections (UTIs).The Center for Disease Dynamics, Economics & Policy (CDDEP) reports that in 2014, the most commonly used oral class of antibiotics for UTI, fluoroquinolones, were experiencing resistance at up to 35% in E. coli. We are a small company with very aggressive timelines for our programs. Consequently, current prices represent an excellent risk-reward ratio. 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. Spero could possibly receive the first sales milestone payment for reaching net sales above $200 million in 2029. 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. Its pipeline product candidates include SPR994, SPR741, and SPR206. Spero Therapeutics Incs EPS estimate is -$0.38. 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. What was Spero Therapeutics Incs price range in the past 12 months? Wolf Haldenstein has extensive experience in the prosecution of securities class actions and derivative litigation in state and federal trial and appellate courts across the country. Heather Smotrich is a Senior Accountant at Spero Therapeutics based in Cambridge, Massachusetts. WebOverview Company Description: Key Principal: Ankit Mahadevia See more contacts Industry: Pharmaceutical preparations Printer Friendly View Address: 675 Massachusetts Ave Ste 14 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. If Tebipenem is approved, GSK has invested $375 million in the deal, excluding commercialization costs. Currently, no hedge funds are holding shares in SPRO. Susannah Walpole is a Head Vice President, Clinical Operations at Spero Therapeutics based in Cambridge, Massachusetts. Spero Therapeutics is actively pursuing collaborations with partners for scientific expertise and funding support.
With their antibiotic expertise and global commercial reach, GSK is ideally positioned to launch tebipenem HBr following regulatory approval as the first oral treatment for complicated urinary tract infections, providing patients with an alternative to in-hospital intravenous therapy. I/we have a beneficial long position in the shares of SPRO either through stock ownership, options, or other derivatives. Spero Therapeutics Inc has a Momentum Score of 94, which is Very Strong. Dr. Hamed has over 20 years of anti-infective experience and has spearheaded the global development and approval of multiple anti-infective products Dr. Hamed has over 20 years of anti-infective exper Alignment with the FDA on a regulatory path forward for the continued development of tebipenem Hbr, Initiation of a Placebo-controlled Phase 2 Trial of SPR720 in Nontuberculous Mycobacterial Pulmonary Disease (NTM-PD) Expected in 4Q 2022. Spero will start a new phase III clinical trial in 2023, following encouraging US FDA regulatory feedback on the proposed clinical trial design. Head of Quality Assurance at Spero Therapeutics . According to ZoomInfo records, Theodore Jenkinss professional experience began in 2018. Nevertheless, I am convinced that these assets can create massive shareholder value. Spero Therapeutics, Inc. is a multi-asset, clinical-stage biopharmaceutical company focused on identifying, developing and commercializing novel treatments for multi-drug resistant (MDR) bacterial infections and rare diseases.Speros lead product candidate is SPR720, a novel oral therapy for the treatment of rare, orphan pulmonary disease caused by non-tuberculous mycobacterial (NTM) infections.Spero also has tebipenem HBr (tebipenem pivoxil hydrobromide; formerly SPR994), designed to be the first broad-spectrum oral carbapenem antibiotic for use in complicated urinary tract infections (cUTI) and acute pyelonephritis (AP). 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, Changes in these assumptions may have a material impact on the backtested returns presented. 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. Read More. The deal with GSK partially confirms these assumptions. When is Spero Therapeutics Incs upcoming earnings report date? Read More . Web Spero Therapeutics welcomes inquiries regarding potential opportunities for collaboration across discovery, development and commercialization. Successful stock investing involves buying low and selling high, so stock valuation is an important consideration for stock selection. Our commitment to the development of effective new agents to address unmet medical needs remains strong, as we seek to identify the optimal path forward for tebipenems regulatory approval, commercialization, and value creation, potentially through external partnerships. 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. Founded in 2013, Spero Therapeutics is a clinical-stage biopharmaceutical company headquartered in Cambridge, Massachusetts. 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. 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. View Jamie Brady's colleagues at Spero Therapeutics. Challenging. 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. Please contact Wolf Haldenstein to learn more about your rights as an investor in Spero Therapeutics, Inc. On October 28, 2021, Spero announced that it had submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Tebipenem HBr for the Treatment of Complicated Urinary Tract Infections including Pyelonephritis (the Tebipenem HBr NDA). However, while Spero may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. Spero Therapeutics Inc does not currently pay a dividend. If to the Participant, at the address set forth on the Stock Option Grant Notice . Spero Therapeutics, Inc. (NASDAQ:SPRO) shareholders should be happy to see the share price up 18% in the last month. The firm has attorneys in various practice areas; and offices in New York, Chicago and San Diego. Drawing on more than 30 years of experience in the pharmaceutical industry, our COO, Timothy Keutzer, is focused on building an intentional community of dedicated employees that seek solutions on a broad range of topics and issues. Approval activity has also been on the rise recently. Spero will be responsible for the further clinical development, in particular the costs for a follow-up phase 3 clinical trial. Based on this information, some sales milestone targets appear to be well within reach. 12% dcf in a 4% world? Even in the event of a failure of the phase 3 trial with Tebipenem HBr, I still derive a fair value of $2.55. About SPRO Spero Therapeutics, Inc., a clinical-stage biopharmaceutical company, focuses on identifying, developing, and commercializing treatments for multi-drug resistant (MDR) bacterial infections and rare diseases in the United States. Employer Identification No.)
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. Wolf Haldenstein Adler Freeman & Herz LLP
WebAn Oral Antibiotic Designed to Treat Nontuberculous Mycobacterial Pulmonary Disease, a Rare Orphan Disease. 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. 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. for the i am an individual who enjoys dealing with public Biotech companys. Susannah Walpole's Phone Number and Email. Access the contact details of our media relations teams at GSK. Tebipenem HBr has been granted Qualified Infectious Disease Product (QIDP) and Fast Track designations by the US FDA for cUTI and acute pyelonephritis treatment. 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. On the other hand, Aquilo Capital sold nearly 2 million of its previously more than 5 million shares in Spero after the deal with GSK. LifeSci Advisors . Medical Consultant at Spero Therapeutics . If approved, tebipenem HBr would be the first oral carbapenem antimicrobial to receive marketing approval in the United States. WebSpero Therapeutics Incs trailing 12-month revenue is $53.5 million with a -50.2% profit margin. You may obtain additional information concerning the action or join the case on our website, www.whafh.com. the foregoing would necessitate a significant workforce reduction and restructuring of Speros operations. For more information, visit https://www.sperotherapeutics.com. We are a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. Wolf Haldenstein Adler Freeman & Herz LLP. Financial Overview of Spero Therapeutics (Source: Author's Chart). Spero Therapeutics, Inc. 675 Massachusetts Avenue . WebSPERO THERAPEUTICS, INC. 2017 STOCK INCENTIVE PLAN, AS AMENDED (Full title of the plan) Ankit Mahadevia, M.D., Chief Executive Officer and President .