Sutro Biopharma: Post ESMO Selloff, Does Their Strategy In FRα Remain Viable?

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Sutro Biopharma is a smaller ADC (antibody-drug conjugate) player with a proven technology platform and multiple pharma collaborations.I chose to revisit with an open mind to assess whether the ...

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Seeing the disappointing post ESMO selloff (across a number of companies that presented at the major medical conference, including Relay Therapeutics), I thought a brief revisit could be in order. My initial assumption is that Luvelta's prospects are being greatly overestimated by an enthusiastic management team, but I'm trying to evaluate this one with an open mind based on the present snapshot. Chart FinViz Figure 1: STRO daily chart (Source: Finviz) When looking at charts, clarity often comes from taking a look at distinct time frames in order to determine important technical levels and get a feel for what's going on. In the daily chart above, we can see shares bouncing around in the $3 to $5 range for much of the past year. Zooming out to weekly chart (not shown), we can see a steep fall from prior levels above $20. My initial take is that each subsequent data update for lead program Luvelta (FRα-Targeting ADC) reflects a narrow therapeutic window that the market is unwilling to assign any credit to. To be fair, the addition of G-CSF has helped mitigate the key adverse event of neutropenia (febrile type less than 5%, discontinuation rate less than 1.5%). Thumbing through their slides, it does feel like clinical momentum is starting to pick up and coupled with a strong cash position (trading at negative enterprise value), I wonder whether the right pieces are falling into place for a rebound in 2025. Overview Founded in 2003 with headquarters in San Francisco (302 employees), Sutro Biopharma currently sports enterprise value of negative $100M (if you include its $50M stake in Vaxcyte). Q2 cash position of $375M provides them an operational runway of ~1.5 years (not including any potential partner milestones coming their way). There are ~82M shares outstanding out of 300M authorized. Accumulated deficit to date is just $152M (a positive sign to my eyes, as they have avoided burning through a lot of cash in their 20+ years of existence). While relying on partner activity has been good for finances, I wonder about management execution if they are licensing out their most promising assets (pneumococcal vaccine, ROR1 ADC) instead of keeping them in-house until later stage of development. The pipeline appears extensive for a company valued below its cash position, with the market giving them little to no credit for any clinical progress being made. Corporate Slides Figure 2: Pipeline (Source: corporate presentation) The stated strategy is to focus on Luvelta's clinical development in phase 2/3 study for platinum-resistant ovarian cancer. Other indications are to follow, including RAM phenotype AML and venture into NSCLC, as well as endometrial cancer. As the target FolRα has been validated by approval and successful launch of AbbVie's (ABBV) Elahere (acquired ImmunoGen for $10 billion last year), Sutro thinks its \"best in class\" candidate could address a broader patient population (lower expressors of the target) along with moving into other oncology indications that Elahere hasn't touched. Per the 10-K filing, the claim is that their XpressCF platform (cell-free based protein synthesis system) will expedite development of best-in-class molecules and access innovative formats including bispecifics, iADCs (immune payload), etc. Being a small company, much of their efforts are partnered out to the likes of Merck, Astellas and EMD Serono among others. Let's move on to September's webcast to decide whether enough has changed with the story for me to get interested. Notes from Wells Fargo  The CEO was the 19th employee, and started in their current position in 2009. Platform technology is \"unparalleled in the industry\" and utilization offers patients both \"more and less\". It's a late-stage oncology company, with a lead program that targets folate-receptor alpha (Luvelta) and they are excited it can deliver more therapy, more efficacy to more patients than existing therapies (Elahere) and less toxicity at the same time. Now Luvelta is in pivotal trials for registration in ovarian cancer, and started trials in a rare form of AML, as well as a NSCLC cohort opened up. \"Pipeline in a product\". They have the ability to make next gen antibody drug conjugates with novel technologies (linker and warhead). STRO-004 is moving into the clinic next year, a tissue factor-targeting ADC with beta glucuronidase linker and exatecan warhead with DAR of 8. They have to lead the industry, not just follow. Other molecules will follow. Immuno-stimulatory ADCs kill cells as they stress the immuno-stimulatory agent, which tells the immune system you need to pay attention and clean up the work that's there. Effectively, you have an immune response that will allow the patient to fight off the cancer as it tries to go again after chemo is no longer active. VaxCyte spinoff applies their tech to make vaccines (brilliant results in most recent data set, now sports $14 billion market cap). This is a good example of the applicability of their \"cell free\" technology. As for bevacizumab Luvelta combo, 35% ORR in all comers was encouraging (irrespective of folate-receptor alpha levels). Patients who were less heavily pretreated had 50% ORR. PFS benefit of 8 to 9 months. They shared an update on that cohort at ESMO (more on that later). The comparator benchmark could be ImmunoGen/AbbVie's mirvetuximab + bevacizumab combo (is it apples to apples?). AURELIO bevacizumab chemo combination in platinum resistant ovarian showed 26% ORR and PFS benefit of 6 months. Elahere data showed 44% ORR, but mostly driven by super-high expressing patients and less so by medium to low. Sutro's data looks differentiated because they can look at even going to lower or no expressors (may not even need to test). Already 8 of 10 women on monotherapy can benefit from Luvelta (doubling the patient population that Elahere today serves, incremental 20% in platinum resistant setting). In earlier line there's much bigger opportunity there and all-comers strategy could disrupt the whole testing paradigm (access 100% of patients in maintenance whether 1L or 2L). They added another cohort, 1st 17 patients dose escalation, now expansion on preferred or optimized dose with more data coming next year (make bigger decisions on earlier line trials). As for the REFRαME-O1 study, per Project Optimus, the pivotal trial has two portions. The first portion satisfies Project Optimus, second is the pivotal phase with chemo control arm (was started in April/May this year, will take a few years to reach patient numbers required for accelerated approval (opportunity as well as full). The company is blinded from the data until readout but can discuss part 1. Early work randomized 44 patients between two best doses (5.2 mg/kg and 4.3mg/kg)- FDA felt 44 patients was not enough, they wanted to see another 50 patients' worth of data to ensure they got the lowest effective dose. The company has now done that, and recruited those patients in less than a year. They will follow for the agreed upon period with the FDA to do exposure response analysis to inform the recommendation on the dose that satisfies Project Optimus. Expect that to conclude and talks with the FDA to decide on optimized dose before year-end. In the meantime, the pivotal trial has both doses going forward along with chemo control arm. Post agreement with FDA, they will drop the non-optimized dose arm (follow those patients for safety). They will only compare optimized dose to chemotherapy (efficient way to accelerate data). Talking publicly about data they are seeing could create issue for ongoing pivotal trial (going to be mum until reach agreement with FDA). They'll make sure the FDA is onboard with them discussing what they are seeing before they do so (otherwise concerns on integrity of data). Perhaps this is why the market is punishing shares of late (lack of disclosure, but for good reason).  The best advice they have so far suggests they can discuss part 1 data at a later date (around the end of the year, but again can't confirm that until after FDA discussion). Are there any other newsworthy items by the end of the year? They completed the expansion cohort in about a month's time (can go fast when you don't have a biomarker approach) and will share more data 1H 25. NSCLC study will have some data next year. Pediatric AML pivotal trial is going on as well (ultrarare form of leukemia that affects kids, diagnosed between the age of 6 months and 2 years). 85% of them do not live 2 years after diagnosis. They get standard chemo to allow them to get stem cell transplant, but many of them never get to remission (get more chemo) and many are not able to maintain remission. They get chemo and that's pretty much it. Compassionate use delivery of Luvelta to physicians around the world gets these kids into complete remission (about 40% of them) allowing for stem cell transplant. Relatively well-tolerated molecule in them (Luvelta does give neutropenia, but these kids often already have it). It only takes about 20 kids to be part of the study, and they can enroll quickly. Provides possibility for a Priority Review voucher, establish infrastructure for faster and more successful launch in the ovarian marketplace. Also, it's simply the right thing to do (provide hope for these kids and their parents). In April 2024, Genmab acquired Profound Bio for $1.8 billion (potential valuation comparator, along with AbbVie acquiring ImmunoGen for $10.1 billion last year). Profound's Rina-S (folate receptor alpha ADC) at ESMO showed 50% ORR in ovarian cancer patients at the 120 mg/m2 dose (all-comers population) as a monotherapy which seems to set the competitive bar quite high.  \"Everyone is trying to get on the bandwagon\" per an analyst playing devil's advocate. They are closely watching the market evolve, and believe Sutro is in a position to be the first to serve the lower & medium expressing patients. Elahere is not currently available in Europe, but they can recruit for their trial at a steady pace to get that broader patient population mix within their study (will be harder to compete for patients for other companies coming in later). An underappreciated point is if they are successful in getting approval in low to medium expression levels, whoever is following Sutro has a different standard of care they are being compared against (not the 12% ORR of chemo but the 30%+ ORR for Luvelta, materially higher bar). The cutoff threshold for Luvelta trial is lower at 25%+ expressors of target, while still seeing consistent efficacy in lower to medium expressor group (not driven by small number of higher expressors, which gives them confidence to pursue much broader label & opportunity). In combination, they might be able to lower that 25% threshold. As for the NSCLC opportunity for Luvelta, consider that ovarian cancer expresses folate receptor alpha upwards of 80%. In lung cancer, about 30% to 60% FRa expression (a good bit lower). They see about 30% FRa expression at TPS cutoff of 25% or higher level. Preclinical data for Luvelta monotherapy and PD-1 combo shows strong activity. Even if it's able to get 1% to 2% of lung cancer, it's worth pursuing. Started the trial this year, they have a handful of patients to look at data next year (phase 2 signal finding study). Moving forward with 4.3mg/kg. they have an option to escalate if able to tolerate/as needed. Newer class of linkers beta glucuronidase are more stable and even less likely to be cleaved outside of the tumor microenvironment. They keep pushing the envelope. For warheads, they're now using exatecans (non-tubulin). The goal is to give patients more in terms of efficacy and less in terms of toxicity. The differentiation for Sutro is how powerful their platform is (Vaxcyte is an early taste of this). STRO-005, 6 and 7 are diving into exatecan ADC (early PK data shows greater exposure to translate to better response and a wider therapeutic window). The platform allows for specific protein design and engineering (could even enable dual payload strategy). Partnership with Astellas on two programs that are iADCs. The industry has a lot of \"me too\" drugs, the goal is to stay ahead of the rest of the industry (continually innovate). Immuno-stimulatory ADC amplifies immune system. Two years ago, they had sufficient data to convince Astellas to do $100M deal with them, two targets moving forward robustly. The idea is to preferentially target the iADC to the tumor microenvironment, cytotoxic gets released and kills tumor cell (acts as a beacon to immune system to come and clean the mess-up). It's a one-two punch to get rid of tumor cells if you will. Preclinical models in mice showed they could rescue a bunch of mice (no more signs of tumor with iADC). They let them live and a month or two later rechallenged them with the same tumor cell line (cancer did not regenerate, immuno-stimulatory effect was lasting and had memory response). Almost like an individualized vaccine in people (IF it works). Partnering is a core priority for them, they need other ideas and need other capital. Since 2009, they've raised $1 billion from partners through the years ($600M also through public and private investors). You don't get $1 billion as a platform company unless you are doing something of value for partners and patients.  My take on the presentation is that the CEO makes a few arguably grandiose claims in my opinion (not in the category of \"cheerleading\" to be fair) but fails to back them up with accomplishments with the internal pipeline as of yet. The company should be commended for the scope of its partnerships and funding via deal activity to date (it shows pharma interest in the tech). However, they did spin off their most lucrative enterprise (Vaxcyte) and their lead asset is pursuing an increasingly crowded opportunity in ovarian cancer (almost as if there's so much effort sunk in that they have to continue). The impact of AbbVie's Elahere is misrepresented in my eyes, as NCCN guidelines recommend its use with Avastin in low and medium FRa expressors (white space remains in no expressors/broad population without the need for FRa testing). As for pursuing tissue factor and subsequent targets, I have to wonder how the company is going to differentiate versus industry heavyweights including Pfizer/SeaGen (Tivdak already approved in cervical cancer) and larger biotech companies with a stronger resource base to move forward. Exelixis (EXEL) comes to mind as a case study for devil's advocate, having recently discontinued its tissue factor-targeting ADC candidate XB002 (finding it \"unlikely to improve upon other competing TF-targeting ADCs currently approved or in development\"). An IND filing is expected next year for XB371 (topoisomerase payload, DAR of 8, dual cleavage linker) to give TF another shot. To sum, with an increasingly crowded field (players as well as targets), my initial stance toward Sutro is one of \"guilty until proven innocent\" (it has to prove there is some kind of differentiation and viable path to a market opportunity with sufficient white space to commercialize on their own or via perhaps by codeveloping a deal with big pharma). ESMO Update As for Luvelta's most recent update in September, I believe it was brief and lacking much substance (per the market reaction, since the share price was down from the highs above $5 to $3.50). A 4.3 mg/kg dose combined with bevacizumab (15mg/kg) every 3 weeks achieved a very respectable 56% objective response rate in late-stage ovarian cancer patients (selected as recommended phase 2 dose). 35% ORR for all dose levels. Expansion at RP2D enrolled 23 more patients so far, with expansion data expected in 1H 25 (I doubt it would move the needle if it stays in the range of the current 56% ORR). Keep in mind, similar to Genmab's Rina-S data (monotherapy), this was in a population irrespective of FRα expression. I do agree the possible white space here is via broad-based (non-biomarker) approach IF they can keep ahead of the competition. My experience is that these larger companies with greater infrastructure can move much faster in terms of getting trials up and running & enrolling patients - which is why I am more skeptical where there's little clinical differentiation, and it's all about who gets to market first. As for more specifics, ORR was 44% in patients with ≥25% FRα expression, while for those with <25% FRα expression it was still an acceptable 29%. No new safety signals were observed, but that still leaves the issue of neutropenia (being managed via prophylactic use of pegfilgrastim). Other Information For the second quarter of 2024, the company reported cash and equivalents of $426M (includes 700k shares of Vaxcyte) as compared to operating expenses of $74.4M (+31% year over year). Research and development expenses rose by ~50% to $62M. While the company has a robust balance sheet and is trading at negative enterprise value, I'd expect cash burn rate to continue increasing as the scope of clinical development expands (pivotal trials enroll high N of patients, move into broader population without biomarker selection and then new candidates move into the clinic). Hopefully partnership milestones help with that (up to $90M in near-term payments from Ipsen for STRO-003, up to $900M in total milestones or bio bucks as we call them given it's unclear how much of that will actually be realized). Sutro stands to receive up to a whopping $3 billion in milestone payments across all pharma partners, not to mention royalties (single digits to midteens) IF anything gets commercialized. As for execution in the clinic and catalysts, ESMO data proved to be a bust. Part 2 of the phase 3 REFRαME-O1 study is underway and the pivotal pediatric AML study is getting started. The phase 2 expansion cohort of bevacizumab combo should report data 1H 25, as will phase 2 signal-finding study in NSCLC. Ipsen-partnered STRO-003 (ROR1-targeting ADC, which I wish they'd kept in-house for greater value creation & potential pivot from folate receptor alpha) will see its IND submitted next year (more milestones expected to help with burn rate). Going back to the topic of competition, I'm reminded of just how important it is to listen to conference calls and presentations of peers (treatment landscape either confirmed or perhaps depicted in a different manner). As mentioned prior, Genman's 50% ORR for Rina-S for all-comers population in advance ovarian cancer (regardless of expression, perhaps without the same safety challenges as Sutro) is a stark reminder of what they're up against. Per Core Biotech holding Acrivon's (ACRV) recent data call, the small company chose to pursue endometrial cancer indication over ovarian because the latter is simply too crowded (11 emerging therapies in platinum-resistant ovarian cancer, 2nd line mirvetuximab covering much of that and other players are splitting the 60% of patients who progress to 3rd line). As for institutional investors of note, I see that Deerfield recently sold out, while Adage Capital owns 2M shares. Suvretta Capital owns 7.7M shares (for some reason I recall they were in big at Otonomy/OTIC, which was a binary bust). Final Thoughts To conclude, at first glance a negative $100M enterprise value looks quite attractive for this \"sum of the parts\" story and in that sense, risk-tolerant investors may want to gain exposure ahead of 2025 data catalysts and overall clinical progress. I tried to revisit with an open mind, hoping to perhaps uncover a turnaround story with some kind of differentiation versus competition in ovarian cancer as well as a steadily progressing pipeline. However, Sutro still does not meet my selection criteria for my Core Biotech portfolio (there's a high probability of clinical success for Luvelta, but I have my doubts on commercial prospects due to the evolving landscape). I also lack confidence in leadership, as they seem to partner our most promising assets while still pursuing a lead that runs the risk of becoming increasingly irrelevant or obsolete as the overall field makes progress. I hope long-suffering shareholders see a turnaround in 2025 (i.e. if NSCLC data is sufficiently positive, it could result in a re-rating), but from my end I'm NOT willing to bet on it. Dilution in the near term does not appear to be a risk, given the company's robust cash position. However, another key risk is that the 2025 expansion cohort update in ovarian cancer could see a similar \"sell the news\" reaction to this year's ESMO data.  One more concern is that I'm not sure the NSCLC readout will be robust enough to move the needle (a handful of patients with limited follow-up), and there's a lot of competition with the next target of TF (tissue factor). Partner progress including iADCs could haul in more milestone payments and improve sentiment if initial signs of success are observed, but on the other hand, if a collaborator pulls out this would weigh on shares as well.","kind":null,"is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"0","news_tag":"analysis","news_rank":0,"symbols":[],"gpt_button":1},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":true,"deviceId":"web-server-community-laohu8-v3","version":"4.29.1","shortVersion":"4.29.1","platform":"web","vendor":"web","appName":"ttm","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2475661395"}