CUE News

Cue Biopharma, Inc. (CUE) possesses the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.

A handful of small-cap stocks have skyrocketed defying the coronavirus-induced market mayhem and extreme volatility.

Cue Biopharma, Inc. (CUE) possesses the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.

The Zacks Analyst Blog Highlights: Cue Biopharma, PJT Partners, Avenue Therapeutics, SpartanNash and Gaia

Just when it looked like time to throw in the towel, the market pulled through and delivered a win. Stabilizing crude oil prices, a few better-than-expected earnings reports as well as the possibility of a fresh fiscal stimulus package all helped inspire confidence among investors.While April's rally doesn’t necessarily signal that the worst is behind us, it’s encouraging to say the least. Add in the opportunity to find exciting growth plays, and you have our attention.According to the Wall Street pros, even amid the ongoing public health crisis, a select group has set itself up for growth to the upside, pointing specifically to the healthcare sector. Stocks falling into this category are well positioned within the industry, and aren’t just in it for the short-term. Rather, these names are poised for some serious share price appreciation through the next year and beyond.We all know that past performance won’t guarantee future results. Still, the best place to start looking for tomorrow’s high-growth stocks is among yesterday’s winners. Using TipRanks’ database, we’ve found three healthcare stocks that saw hefty gains in 2020. Each name is well-loved by Wall Street analysts, and has received enough bullish calls to score a “Strong Buy” consensus rating.Compugen Ltd. (CGEN)Genomics-based drug and diagnostic discovery company Compugen specializes in developing therapeutic and diagnostic biomarker product candidates including proteins and monoclonal antibodies. With an already achieved 147% year-to-date gain and an impressive lead candidate, COM701, the analyst community sees vast potential for the company in the immuno-oncology (IO) space.Weighing in for investment firm SunTrust, analyst Asthika Goonewardene calls COM701 “first-in-class” and the “strongest lever in a hot, new immuno-oncology (IO) cluster of potential drug targets.” “Correctly targeting this IO cluster not only takes the brakes off the immune cells (blocking antagonist checkpoints) but also steps on the gas pedal (agonist effect). CGEN's approach may achieve this,” he explained.Part of what sets CGEN’s asset apart is that it acts on a different component of the cluster, with current data suggesting this approach will lead to better results. It should be noted that CGEN is the only player currently targeting this mechanism, putting it two to three years ahead of its peers, in Goonewardene’s opinion. The analyst added, “CGEN recently announced COM701 showed single agent activity (tumor shrinkage) at a more optimal dose. This is a key hurdle in IO and backs our positive sentiment.”Looking forward, Goonewardene believes that data releases slated for the second half of 2020 and the first half of 2021 should demonstrate the ideal combinations of COM701 so it can be further evaluated in selected tumor types and achieve ~$3 billion in unadjusted peak sales by 2029.As it also has a collaboration with industry heavyweight Bristol Myers and other top players are developing candidates to target the TIGIT component of the cluster, it’s no wonder Goonewardene takes a bullish stance on CGEN. To kick off his coverage, he published a Buy rating and set a $16 price target.All in all, the rest of the Street echoes the analyst’s sentiment. Only Buy ratings have been assigned in the last three months, 4 to be exact, and thus, the consensus rating is a Strong Buy. At $18.00, the average price target is more aggressive than Goonewardene’s and suggests 23% upside potential. (See Compugen stock analysis on TipRanks)Cue Biopharma, Inc. (CUE) Hoping to provide better treatments for cancer and autoimmune diseases, Cue Biopharma is developing a novel class of injectable biologics to selectively engage and modulate targeted T cells within the body. In the last month alone, shares have climbed 88% higher, with one analyst noting that the current state of the market has set it up for even more gains.JMP Securities’ Reni Benjamin tells clients that after a conference call with the company’s CSO and CMO, he has a better understanding of its Immuno-STAT platform and future clinical plans. With respect to the platform, the analyst found its breadth and depth promising, with it potentially being able to address multiple indications. Take its CUE-101 candidate for example. While the therapy was evaluated first in head and neck squamous cell carcinoma (HNSCC), it could potentially be used to treat any HPV16-driven cancer.Expounding on this, Benjamin said, “Notably, prototypes for the next-generation of molecules have already emerged, with a pre-made scaffold receptive for chemical peptide conjugation (instead of fusion protein) that allows for even easier target switch, streamlined manufacturing, and potential registrational efficiencies Further, replacing the co-stimulator with a dampener (e.g., PD-L1) has the potential to drive the use of Immuno-STAT toward autoimmune-based indications...”Additionally, a robust level of selectivity and therapeutic potency was shown by preclinical data. “Despite competitors that have engineered the ability to avoid regulatory T cells, CUE has designed a product candidate that can not only avoid regulatory T cells, but also activate antigen-specific T cell repertoires. Importantly, the Immuno-STATs are able to activate both pre-existing and naive T cells,” Benjamin commented.It should also be noted that management has designed its ongoing first-in-human study with the goal of achieving platform validation. Combine this with a Merck collaboration advancing in type 1 diabetes and a $51 million pro forma cash position, and you get a bullish analyst review.To this end, Benjamin kept a Market Outperform rating and $30 price target on the stock. Should this target be met, a 21% twelve-month gain could be in the cards. (To watch Benjamin’s track record, click here)Turning now to the rest of the Street, other analysts like what they’re seeing. With 100% Street support, the consensus is unanimous: CUE is a Strong Buy. (See Cue stock analysis on TipRanks)GenMark Diagnostics (GNMK)Using its patented eSensor electrochemical detection technology, GenMark develops diagnostic instruments and multiplex molecular panels. While its ePlex SARS-CoV-2 (COVID-19) test has helped drive huge gains, 110% in the last month, some members of the Street believe its future is only getting brighter.Back in March, the company announced that its test had been granted FDA emergency use authorization (EUA). The test can be run on GNMK's ePlex system, and each test is expected to be priced at around $110. Part of the excitement surrounding the test is related to its speed, with it able to produce results in 90 minutes. Not to mention 96 tests can be run in eight-hour shifts.Thanks to the massive level of interest, the test was widely expected to serve as a significant tailwind for the company in 2020. Based on GNMK’s preliminary Q1 2020 results, this appears to have been the case. In its preannouncement, GNMK reported Q1 revenue grew 80% year-over-year to hit $38.7 million, flying past the Street’s $26.4 million (23% year-over-year growth) estimate. Adding to the good news, the company is slated to see some serious gross margin expansion. We’re talking about 40% here.Even though these figures are certainly impressive, BTIG analyst Sung Ji Nam notes that there are a few important factors to consider. First and foremost, RP demand had more of an effect on revenue than the COVID-19 tests. “While we expect continued tailwind for COVID-19 testing near-term, we are more encouraged by the strong ePlex placements in the quarter which bode well for GNMK's core syndromic panel testing business both in the near term and longer-term,” he stated.As for the second, Nam commented, “Full year revenue guidance was raised to 27-39% growth vs. 14-25%, previously: While the full-year revenue guidance was raised by the 1Q beat, GNMK has better visibility than most for its business near term and is well-positioned for the remainder of the year, in our view, given the strong momentum for the RP panel and COVID-19 testing. GNMK is also currently developing an ePlex RP2 Panel that will include the SARS-CoV-2 viral target with funding from BARDA (up to $749,000), which the company expects to have available for the next flu season.”With GNMK continuing to expand its test menu in sydromic panel testing and its solid standing in a rapidly growing segment of the IVD market, the deal is sealed for Nam, as he reiterates a Buy rating on the stock. (To watch Nam’s track record, click here)Like Nam, the rest of the Street has high hopes for this stock. GNMK’s Strong Buy consensus rating breaks down into 4 Buys and 1 Hold issued in the last three months. (See GenMark stock analysis on TipRanks)To find good ideas for healthcare stocks trading at attractive valuations, visit TipRanks’ Best Stocks to Buy, a newly launched tool that unites all of TipRanks’ equity insights.

Cue Biopharma, Inc. (CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells within the body, announced today it will present at the Cowen & Co. 40th Annual Health Care Conference on Monday, March 2, 2020 in Boston, Massachusetts and the 30th Annual Oppenheimer Healthcare Conference on Wednesday, March 18, 2020 in New York. A live and archived version of the webcast will be available at http://wsw.com/webcast/cowen57/cue/.

Cue Biopharma, Inc. (CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells within the body, announced today it will host a conference call and webcast to provide a business update on Tuesday, May 19, 2020 at 4:30 p.m. EDT. Members of the Cue Biopharma executive management team will provide an update on the Company’s platform and pipeline progress, as well as updates on its strategic objectives and anticipated milestones. Cue Biopharma, a clinical-stage biopharmaceutical company, is engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells within the body to transform the treatment of cancer and autoimmune diseases.

Cue Biopharma, Inc. (CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells within the body, announced today that the company’s therapeutic Immuno-STAT™ (Selective Targeting and Alteration of T cells) platform is scheduled to be featured in a Merck presentation at the Antigen-Specific Immune Tolerance Drug Development Summit taking place on Feb. 25-27, 2020 at the Colonnade Hotel in Boston, Massachusetts. Cue entered into a strategic research collaboration and license agreement with Merck in November 2017 to develop biologics for the treatment of selected autoimmune diseases.

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Cue Biopharma, Inc. (CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells within the body, announced today Dr. Mary Simcox, vice president of translational biology and early development, will give a presentation highlighting the strategy and  tactical details for testing CUE-101, the company’s lead biologic drug candidate, in a first-in-human Phase 1 trial (NCT03978689) at the Biomarkers Series UK taking place on Feb. 18-20, 2020 at the Manchester Central Convention Complex.

Cue Biopharma (CUE) is seeing favorable earnings estimate revision activity and has a positive Zacks Earnings ESP heading into earnings season.

Cue Biopharma, Inc. (CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells within the body, announced today a poster presentation featuring pre-clinical data on CUE-102/A02 and CUE-102/A24, the company’s second and third drug candidates from the CUE-100 series at the American Association for Cancer Research (AACR) Virtual Annual Meeting II. CUE-102 biologics are Immuno-STATs™ (Selective Targeting and Alteration of T cells) designed to selectively target and expand Wilms’ tumor 1 (WT1) specific T cells for the treatment of patients with solid and hematological cancers.

Zacks.com featured highlights include: Farmers National, Independent Bank, First Financial Bankshares, HarborOne and Cue Biopharma

Extended cash runway with $33.3 million from at-the-market equity offerings in Q4’19Focused and effective execution of clinical development of CUE-101 as a Phase 1 monotherapy.

For those who like patterns, biotech names’ growth stories tend to look remarkably similar. These stocks are less reliant on earnings reports and more on a few select markers which can decide what direction they will take in the near-term. A favorable outcome from a regulatory committee or promising data from a clinical trial can send the stock soaring. Conversely, rejection or disappointing readouts can send the company’s share price tumbling down. While they present possible mercurial upside, these tickers aren’t for the faint of heart because although the patterns usually play out, the direction they might take is very hard to predict.So, how should investors choose which biotechs to invest in? There are different strategies, of course, but one trusted way is to listen to the experts. Investment bank BTIG is a well-known name on the Street, housing several top analysts. The company has identified three companies in the sector that will present new data over the coming months, and BTIG analysts think positive results can propel each of them forward.Using the Stock Comparison tool from TipRanks, a company that tracks and measures the performance of analysts, we were able to zero in on their choices and find out why the firm finds them so compelling. Let’s get familiar with the data at hand. Sarepta Therapeutics (SRPT)Let’s start off with a good example of the impact regulatory forces can have on a stock. Sarepta Therapeutics made headlines towards the end of 2019, when the FDA approved Vyondys 53, the company’s treatment for Duchenne muscular dystrophy (DMD) patients with exon 53 mutations. The approval came as a surprise as only a few months earlier, Sarepta received the dreaded CRL (complete response letter) from the FDA following its original submission. As is de rigueur in the sector, Sarepta stock responded to the announcement by soaring over 30% in a day.In addition to the recently approved drug, the genetic disorder-focused biotech has a robust pipeline, with gene therapy programs in DMD and LGMD (Limb Girdle Muscular Dystrophy). BTIG’s Tim Chiang believes the company is steadily progressing with these key programs.The analyst said, “We believe SRPT is making progress on the gene therapy manufacturing front, and has achieved yields sufficient to begin study 301 (which we think could enroll up to a hundred or more patients). We believe SRPT plans to provide an interim look at data from this study in ~15 patients dosed (evaluating expression levels at ~3 months post dosing). In LGMD2E, SRPT has dosed two patients in the higher dose cohort, with a third patient to be dosed shortly. We expect a data read out from this high dose arm in early 2Q.”Chiang expects that US gene therapy sales in the DMD market will reach a peak in 2024, with the figure landing at roughly $2 billion. There are three companies currently in the race to develop gene therapies for the treatment of DMD; Sarepta, according to the analyst, is leading the way and could be the first to enter the US market with its gene therapy for DMD in the second half of 2021.Chiang added, “We think one of the key differences among the 3 micro-dystrophin gene therapy programs in the clinic are that both Solid Biosciences (SLDB, Neutral) and Pfizer have studies where ascending dose cohorts are being utilized. In contrast, Sarepta’s study incorporates just one dose (2E14 vg/kg).”So, what does this mean? It means Chiang kept his Buy rating on Sarepta, along with a price target of $190. Should the target be met, investors stand to see a handsome 64% gain over the next year. (To watch Chiang’s track record, click here)The Street, too, is bullish on the DMD fighter. A Strong Buy consensus rating breaks down into 18 Buys and a single Hold. The average price target comes in at $204.33 and indicates potential upside of 76%. (See Sarepta stock analysis on TipRanks) IMV Inc. (IMV)IMV’s market performance in 2019 was a disappointing affair; The stock lost 39% of its value along the way. By contrast, 2020’s performance so far has been the exact opposite - and some. The stock is up by 58% year-to-date. According to BTIG’s Thomas Shrader, there is more to come, too.The cancer fighter’s lead candidate is DPX-Survivac, which targets the surviving TAA (tumor associated antigen) that is overexpressed in more than 20 different types of cancers. Clinical data so far has been promising, with long disease-free intervals in the ovarian cancer (OC) adjuvant setting and compelling treatment response rates in both OC and DLBCL (diffuse large B-cell lymphoma). Important DPX-Survivac data is expected this quarter which Shrader notes “could greatly de-risk the current programs and potentially demonstrate the utility of the low-COGS DPX platform to deliver many other TAAs and neoantigens.”The 5-star analyst added, “The drug has shown robust and prolonged CD8 TCell responses in the adjuvant setting and a Phase 1b/2 trial has shown a 100% DCR and 60% ORR in the subgroup of patients with non-bulky disease (tumor burden < 5 cm) most of which are platinum-resistant (few treatment options). The company expects to provide topline Phase 2 monotherapy data in mid-February 2020 that we expect to be an important catalyst for the story.”Ahead of this upcoming data readout, Shrader is siding with the bulls. The analyst initiated coverage of IMV with a Buy rating along with an $8 price target. The implication? Further gains in the shape of 75% over the next 12 months. (To watch Shrader’s track record, click here)The Street agrees. A total of 6 Buys add up to a unanimous Strong Buy consensus rating. With an average price target of $9.31, the analysts see potential upside of 104% for IMV over the coming 12 months. (See IMV stock analysis on TipRanks) Cue Biopharma Inc. (CUE)A fellow company taking the fight to cancer is Cue Biopharma. In 2019, Cue’s exceptional performance beat the market considerably. The stock added an astounding 238% to its share price throughout the year. Following such a surge, though, is this the right time to get in on this high-flying biotech?Yes, it is, according to BTIG’s Thomas Shrader. In fact, the 5-star analyst just recently initiated coverage of Cue with an emphatic Buy rating. The thumbs up comes with a price target of $26, indicating Shrader believes an additional 71% will be added to Cue’s share price over the next 12 months.So, what’s all the fuss about, then? A cure for cancer is one of modern medicine’s most coveted prizes. Cue is working on an immunotherapy platform which will assist immune systems by recognizing solid tumor cells and repeatedly attacking them until they stop working.The company’s lead candidate is CUE-101, which was developed for patients with head and neck cancer driven by human papillomavirus (HPV). Topline results from a Phase 1 trial are expected later this year, and so far, results have been promising.Shrader said, “Data to date is preclinical but the lead programs termed CUE-101 has exploited well defined subunits and demonstrated tumor antigen-specific T-cells responses without the accompanying systemic immune toxicities that characterize many competing approaches… Preclinical data confirm both robust T-Cell responses and an attractive safety profile setting the stage for clinical studies. These studies have stated (first dosing September 2019) and, based on the preclinical safety profile, will begin with doses that could be efficacious. Clinical data validating the overall approach are expected around 3Q20 and, if promising, a significant pipeline in additional applications should be de-risked.”Currently, the rest of the Street remains rather quiet on Cue, with only one other analyst chipping in with a take on the biotech’s prospects. The additional Buy recommendation means Cue receives a Moderate Buy consensus rating. The average price target comes in at $24 and implies upside potential of 58%. (See Cue Biopharma stock analysis on TipRanks)

Cue Biopharma, Inc. (CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells within the body, announced today it has entered into a clinical collaboration agreement with Merck (known as MSD outside the United States and Canada), through a subsidiary, to evaluate the combination of Cue Biopharma’s investigational product candidate CUE-101, a first-in-class biologic, with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in patients with advanced head and neck cancer. Under the terms of the agreement, Cue Biopharma will conduct a Phase 1 study, KEYNOTE-A78, evaluating CUE-101 in combination with KEYTRUDA in first-line HPV+ advanced head and neck cancer.

Cue Biopharma, Inc. (CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells within the body, announced today it has entered into a research collaboration agreement with Dr. Michael Dustin and the University of Oxford to determine the molecular mechanisms underlying the activity of its IL-2 based CUE-100 series Immuno-STAT™ (Selective Targeting and Alteration of T cells) Biologics. “Cue Biopharma is pleased to enter into this strategic collaboration with Dr. Dustin and the University of Oxford,” said Saso Cemerski, senior director of immuno-oncology discovery and translational immunology at Cue Biopharma.

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Greetings, and welcome to Cue Biopharma first-quarter 2020 earnings call. It is now my pleasure to introduce your host Ashley Robinson, investor relations. This is Ashley from LifeSci Advisors, and thank you for joining us on today's investor and analyst update call.

CAMBRIDGE, Mass., May 19, 2020 -- Cue Biopharma, Inc. (NASDAQ: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to selectively.