Spero Therapeutics Delivers On Game Plan To Create Shareholder Value

seekingalpha04-23

Spero Therapeutics, Inc. has continued to build and advance its pipeline over the past several months and is now on the verge of generating landmark data with multi-bagger potential.Spero has ...

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23:37 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://seekingalpha.com/article/4685311-spero-therapeutics-delivers-on-game-plan-to-create-shareholder-value><strong>seekingalpha</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>Spero Therapeutics, Inc. has continued to build and advance its pipeline over the past several months and is now on the verge of generating landmark data with multi-bagger potential.Spero has ...</p>\n\n<a href=\"https://seekingalpha.com/article/4685311-spero-therapeutics-delivers-on-game-plan-to-create-shareholder-value\">Source Link</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"GSK","symbol_name":"葛兰素史克","start_time":0,"source_url":"https://seekingalpha.com/article/4685311-spero-therapeutics-delivers-on-game-plan-to-create-shareholder-value","article_id":"2429111214","we_media_id":null,"thumbnails":["https://static.seekingalpha.com/cdn/s3/uploads/getty_images/1413265641/image_1413265641.jpg"],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2429111214","pubTimestamp":1713886637,"sourceInfo":{"source_id":"seekingalpha","name":"Seeking Alpha"},"weMediaInfo":null,"summary":"Spero Therapeutics, Inc. has continued to build and advance its pipeline over the past several months and is now on the verge of generating landmark data with multi-bagger potential.Spero has 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Anna Markina/iStock via Getty Images Overall, Spero Therapeutics, Inc. (NASDAQ:SPRO) is on track for success and its three pipeline assets are progressing step by step. Based on the SPA agreement with the FDA, the first patients in the second Phase 3 trial for Tebipenem HBr in cUTI was enrolled at the end of 2023 and the data readout is expected in mid-2025. SPR720 is on track to report data from its pivotal Phase 2 proof-of-concept study in the second half of 2024. And for SPR206, the FDA has given the green light by confirming the IND to proceed with the Phase 2 trial, which can now be initiated subject to third-party funding. The announcement by competitor AN2 Therapeutics (ANTX) to voluntarily suspend patient enrollment in the trial is another very positive development for Spero. However, all these developments have not failed to impact Spero's share price. Therefore, I will take this opportunity to take a look at the developments of the last couple of months and the outlook for the future. I, personally, believe that Spero is fundamentally undervalued based on the GSK aka GlaxoSmithKline (GSK) deal alone, regardless of the assets in the pipeline. For more information, see my first article on Spero. However, the pipeline itself has huge potential value that, in my view, more than justifies the current low market cap. For more information on the other assets in the pipeline, please see my second article. Business of Spero Therapeutics Logo of Spero Therapeutics (Source: Company Homepage) Readers already familiar with the company may wish to skip the brief introduction. Spero Therapeutics is a clinical-stage, multi-asset biopharmaceutical company focused on novel therapeutic approaches to treat multi-drug resistant and life-threatening bacterial infections and rare diseases. Spero's multiple late-stage assets addresses indications with both significant unmet medical need and strong commercialization opportunities. In addition to the lead compound SPR720, the pipeline includes two partnered programs, Tebipenem HBr and SPR206. Tebipenem HBr in cUTI Spero is advancing the development of Tebipenem HBr as planned. Spero has not only signed a Special Protocol Agreement (SPA) with the FDA, but has also enrolled the first patient in the pivotal study. An SPA ensures that the requirements of the FDA are met and that approval is almost guaranteed if the study results are positive. Tebipenem HBr has already shown positive results in an earlier Phase 3 trial in cUTI and has been approved in Japan for many years, so I have little doubt about the success of the second Phase 3 trial. Compared to the previous Phase 3 study with Tebipenem HBr, several adjustments have been made. Not only has the comparator epipenem been replaced by imipenem-cilastatin, but the study is now enrolling nearly twice as many patients (2,648 vs. 1,372 participants). The primary analysis for the study will be a non-inferiority assessment in the microbiology intention-to-treat population based on a 10% NI margin. The last pivotal trial with Tebipenem HBr and 1,372 patients cost around $50 - $60 million and took around 1 year from the recommendation to continue the trial based on the analysis of 33 patients to the publication of the top-line data. Publication of the PIVOT-PO trial, which has now been launched, is planned for the second half of 2025. Based on positive study data, the sales and marketing partner GSK is planning approval and market launch by 2026. Over the next 24 months, Spero will receive an additional $95 million from GSK under the license agreement, payable in four equal tranches to cover the costs of the study. Thereafter, Spero is eligible to receive an additional $25 million in development milestones if GSK submits an NDA and $150 million in potential commercial milestones based on first commercial sales in the U.S. and Europe. Upon successful commercialization, Spero is eligible to receive an additional $225 million in potential sales-based milestones and low single-digit royalties on sales up to $1 billion. If sales exceed $1 billion, the milestone payments will be eliminated and Spero will be eligible for higher royalty payments. Tebipenem has the potential to reach blockbuster status because given the high prevalence of cUTI patients, you don't need very aggressive assumptions on expected penetration or pricing to see the value proposition for the oral carbapenem - Source: Sath Shukla. Due to increasing antibiotic resistance, SPR720 will play an increasingly important role in an area where little research has been conducted recently. In addition to a different mechanism of action with an oral dosing regimen, SPR720 has advantages with its activity against a wide variety of resistant MDR Gram-negative bacteria, its excellent safety profile and the low likelihood of drug resistance due to its use as a monotherapy and the limited usage in dedicated indications. Ertapenem is currently the most widely used antibiotic for the treatment of urinary tract infections. With approximately 9 million treatment days and a daily price of $350, it is easy to imagine that Tebipenem HBr has the potential for blockbuster status. Additional growth potential could come from other indications where ertapenem is already used, such as lung infections, bloodstream infections and diabetic foot infections. Based on the expected cash flow in the coming months from the partnership with GSK, I would calculate a very conservative NPV of $130 million for Tebipenem HBr, or about $2.42 per share. Additional potential value is derived from the agreed sales milestones (up to $225 million) and royalty payments. Calculated NPV based on the Tebipenem HBr deal with GSK (Author's Chart) SPR720 in NTM SPR720 represents a new class of antibacterial agents that target enzymes essential for bacterial DNA replication and is being investigated in NTM lung disease. NTM is a chronic and serious lung disease that causes debilitating symptoms and a decline in lung function. It can have a significant impact on the physical and emotional well-being of patients. Combination therapies may become the standard of care in the future and at the moment. SPR720, with its well-tolerated oral formulation, could be a key component. The timeline for SPR720 has been slightly delayed and results from the Phase 2 study are now expected in the second half of 2024 instead of the first half of 2024. On the other hand, Spero has added a fifth arm and is now enrolling up to 35 patients with treatment-naïve or treatment-experienced but without refractory NTM lung disease. In addition, management recently confirmed the timeline again due to the good progress made. Once patient enrollment has been completed, it will be possible to provide a more precise estimate for publication of topline results. The study will monitor the bacterial population from day 1 to day 56, which means we can expect topline results approximately 4 months after full enrollment. For more information on NTM lung disease in general and the role of SPR720 in particular, I recommend the linked articles. SPR720 is a novel therapeutic agent that has demonstrated activity against a range of NTM species, including MAC and MAB. Encouraging in vitro and pre-clinical data demonstrate that SPR720 is active both alone and in combination with standard-of-care agents, with no evidence of cross-resistance to such agents. It is generally well tolerated with mainly gastrointestinal and headache adverse events of mild or moderate severity. Source: Winthrop et al. There is very little to report on SPR720 at the moment. Therefore, I would like to highlight the developments in the peer segment with AN2 Therapeutics and Insmed (INSM).  The peer group comparison shows the potential of the SPR720. (Source: Author's Chart) An2 Therapeutics made its IPO debut on March 29, 2022, raising new capital at $15. An additional $65.5 million in capital was raised on August 15, 2023, at a price of $9. In general, the company's pipeline is aimed at addressing high unmet needs in rare, chronic, and serious infectious diseases. The most advanced product candidate is epetraborol, which started enrolling NTM patients in the pivotal phase 3 part of the study in September 2023.  In February, ANTX announced the disappointing news that it had voluntarily suspended patient enrollment after a blinded top-line analysis of the ongoing Phase 2 trial showed lower than anticipated efficacies. Top-line results from the Phase 2 trial with 80 patients are still expected in the summer of 2024, and ANTX will decide regarding whether to proceed with the Phase 3 trial. With epetraborol being the only product candidate in advanced trials and the setback due to lower than expected efficacy, the stock dropped 80% from $20 to below $4 on the bad news.  Because Spero has a different mechanism of action, the presumed failure of AN2 cannot be extrapolated to the results of SPR720. Instead, Spero now has the most advanced oral drug in clinical development. In addition, it should now be easier for Spero to do the final patient enrollment in the study. What we have communicated internally, and externally in light of these recent developments, is that our program is potentially the first oral therapy out there, certainly in first line patients, is going to be under greater evaluation and scrutiny, arguably, than ever before. Source: Sath Shukla. The existing funding of ANTX is expected to support the company until mid-2025, beyond the publication of the Phase 2 results. If the Phase 2 results are positive, which is unlikely following the voluntary enrollment pause, the company plans to file for conditional approval in the U.S. based on the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD Pathway). An2's regulatory strategy is based on Insmed regulatory path as a reference, which was the first company to succeed via the LAPD pathway with Arikayce in 2018. A drug approved under the LPAD pathway is an antibacterial or antifungal drug approved to treat a serious or life-threatening infection in a limited population of patients with unmet needs. Source: FDA. Insmed is a pioneer in the development of drugs for NTM lung disease and currently has the only approved product for refractory NTM, Arikayce. Following a highly successful launch, Insmed expects annual sales of approximately $340 - $360 million and further growth in the coming years. Following the approval in 2018, Insmed published positive study data for Arikayce in September 2023 and is evaluating the submission of an accelerated approval application for newly infected NTM patients based on the positive study results. A second NTM study with an additional 250 patients enrolled with newly diagnosed or recurrent lung infections is expected to deliver final results for this indication in 2025. Both An2 and Insmed illustrate the direction in which Spero and SPR720 could develop. NTM lung disease is associated with multidrug resistant bacteria, and as none of the therapies currently in development are effective in all patients, combination therapies may be the most promising solution in the future. Even with the development of new compounds in this indication, there is likely to be potential for all drugs due to the high unmet medical need. I am pretty sure that SPR720 will gain attention and visibility in the coming months, at the latest with full patient enrollment, which will lead to the positioning of new investors in Spero. Currently, Spero is already focusing on the requirements of the FDA based on the experience of its competitors. Further studies, e.g., on the interaction with other drug agents, are being conducted in parallel. Based on positive study data, Spero will inform about the regulatory pathway. An approval under the LPAD pathway could be possible.  The SPR720 data readout represents the largest and most important milestone in the near term, but also the greatest risk in the event of disappointing data. SPR206 Spero has filed an Investigational New Drug (IND) application for SPR206 and received FDA clearance to proceed with a Phase 2 study in the coming months. The development of SPR206 is entirely externally funded and is not a high priority at this time. SPR206 is an intravenous drug for the treatment of Gram-negative infections in the hospital setting. With its profile, SPR206 has the potential to replace currently prescribed regimens such as colistin, while providing patients with an option with a significantly reduced risk of kidney injury. SPR206 differs from all other product candidates in development in its mechanism of action, which is important as it reduces the risk of antibiotic resistance. Pfizer (PFE) has already validated the compound in a package of $120 million for the ex-U.S. and ex-Asia territories, plus royalties. In addition, Spero should be eligible to receive further milestone payments from its partners with the start of Phase 2 of SPR206.  Risks But as with any company, there are risks that need to be mentioned. I think these risks have less to do with the investment case and more to do with the upside potential of the pipeline. The bear case would be the failure of all three assets in clinical trials. GSK will not file an NDA, and Spero will only receive the $95 million already committed to cover ongoing costs. In this case, I expect Spero to trade at about liquidation value or 80% of net cash, which will be roughly $0.65 per share. In between, there is a lot of potential for individual assets to fail in the trials. The failure of each asset has different implications that would have to be factored in. In addition, both studies with Tebipenem HBr and SPR720 may experience delays in patient enrollment. A delay in enrollment would result in a lower cash balance at the time of data analysis and further increase the risk described above. In this case, a delay in the data for SPR720 to the first half of 2025 would be more likely, but less critical, than a delay in the data for Tebipenem HBr. There is also a short-term risk that Spero's share price will continue to decline in the coming weeks due to bearish sentiment and macroeconomic factors. Since my analysis is based on a fundamental assessment of the company rather than perfect timing, I feel free to neglect this risk here. Summary and Update on Investment Case My initial investment case remains intact. Although Spero's pipeline has three value drivers, each of which can justify the entire market cap on its own, I want to focus on the milestone payments from GSK. I think Spero is very well protected on the downside because of its low market cap and the value of the pipeline based on the cash balance and the expected payments from the GSK deal. In the event of positive study data, Spero should be able to obtain regulatory approval under the SPA. There is no additional investments required or risk for Spero as all commercialization activities will be handled by GSK. Currently, GSK expects to launch Tebipenem HBr by 2026. An additional $150 million is due on the first sale of Tebipenem HBr. In addition, Spero is eligible for tiered sales payments of $225 million and low single-digit royalties on sales up to $1 billion, after which the milestone payments will be replaced by higher double-digit royalties. The milestone payments are particularly attractive because they are independent of business and market trends. Remaining potential milestone payments from GSK (Company filing) At the current share price, Spero has a market capitalization of $75 million. Excluding the already committed payments from GSK over the next 24 months, of which $23.8 million has already been received in the first months of 2024, Spero has cash and cash equivalents of $75 million and an enterprise value of only $9 million. Excluding future milestone payments, some of which are already committed, the cash runway remains at 2H 2025. I expect cash burn to be slightly higher, with increasing expenses for Tebipenem HBr, while SPR206 will be advanced only if third-party funding is secured. Financial overview of Spero Therapeutics (Source: Author's Chart) Institutional ownership remains the only negative I can think of at the moment. After the major change in strategy and the partnering of Tebipenem HBr, many investors have turned their backs on Spero, and a new and compelling shareholder structure has not yet emerged to support the company. Institutional Ownership of Spero (Source: Nasdaq.com) I expect more visibility and attention on Spero and a fair valuation in the coming months due to the near-term catalyst. I am taking advantage of the current prices to add to my position, but at the same time, I would recommend de-risking the position ahead of the landmark data in the second half of the year.  Editor's Note: This article discusses one or more securities that do not trade on a major U.S. exchange. 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