|Bid||5.62 x 1300|
|Ask||5.63 x 1100|
|Day's Range||5.61 - 5.81|
|52 Week Range||1.21 - 7.09|
|Beta (5Y Monthly)||1.36|
|PE Ratio (TTM)||N/A|
|Earnings Date||Aug 10, 2020|
|Forward Dividend & Yield||N/A (N/A)|
|1y Target Est||12.20|
Joining me on the call today are Sujal Shah, chief executive officer; Dr. Sujal will provide an update on recent progress and plans on the development program for seladelpar, as well as a brief summary of our financials before we open the call up for Q&A. Before we begin, I'd like to remind everyone that statements made during this conference call, including the Q&A session, relating to CymaBay's expected future performance, business prospects, events or plans, including clinical plans, regulatory approvals and anticipated time lines and data release dates and cash runway are forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995. Although the company believes that the expectations reflected in such forward-looking statements are based upon reasonable assumptions, actual outcomes and results are subject to risks and uncertainties and could differ materially from those forecast due to the impact of many factors.
FDA lifts all clinical holds on seladelpar Positive topline data announced from ENHANCECompany to reinitiate clinical development of seladelpar for patients with PBCCash sufficient to fund current operating plan into 2022 Conference call and webcast today at 4:30 p.m. ETNEWARK, Calif., Aug. 10, 2020 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, today announced corporate updates and financial results for the second quarter and six months ended June 30, 2020. Specifically, in the second quarter and through early August 2020, CymaBay achieved significant progress in its ongoing efforts to review its strategic options, one of which included completing a scientific investigation and working with the FDA to lift the clinical holds on the seladelpar INDs in nonalcoholic steatohepatitis (NASH), primary biliary cholangitis (PBC) and primary sclerosing cholangitis (PSC), the three liver diseases in which CymaBay had terminated clinical studies late last year. Sujal Shah, President and CEO of CymaBay, stated, “We are thrilled with the significant progress made to date in our efforts to conduct a review of strategic options, one of which was to pursue the reinstatement of our seladelpar program. Specifically, in May, we convened a panel of expert liver pathologists and hepatologists that unanimously concluded after a thorough, independent investigation, that there was no clinical, biochemical, or histological evidence of seladelpar-induced liver injury for patients enrolled in our Phase 2b NASH study. We discussed the panel’s findings and related information with the FDA and submitted complete responses to the agency, and in July, the FDA notified us that all clinical holds on seladelpar were lifted. In addition to this favorable outcome, we evaluated and announced last week positive topline results from our ENHANCE study of seladelpar in PBC which, despite being terminated early, provided sufficient data which appear to support seladelpar’s efficacy and tolerability in this patient population. After receiving notification from the FDA, and reviewing the latest clinical data from the ENHANCE study, we stopped our review of strategic options having decided to focus on reinstating the clinical development program for seladelpar in PBC and to continue to evaluate seladelpar for other indications. We have also been very successfully at minimizing our operating expenses through the first half of the year and expect our cash to fund our current operating plan into 2022.”Recent Corporate Highlights * In May 2020, a panel of eight of the world’s foremost expert liver pathologists and hepatologists, whose collective experience relevant to CymaBay’s investigation includes drug-induced liver injury, NASH and cholestatic liver diseases, completed a four-day independent review analyzing findings from CymaBay’s NASH Phase 2b study, and the results of independent pathologist’s reviews of the study biopsies, which included a blinded unpaired review and a paired review blinded to chronologic order of the biopsies. The panel unanimously supported lifting the clinical hold for seladelpar and re-initiation of clinical development pending approval by the FDA. In June 2020, CymaBay discussed the data and the panel’s conclusions with the FDA and submitted complete responses to the agency. In July 2020, the FDA lifted clinical holds on seladelpar in all indications with open INDs (NASH, PBC and PSC). * In August 2020, CymaBay announced positive topline results from ENHANCE for seladelpar in patients with PBC. Topline data for patients through 3 and 6 months demonstrated anti-cholestatic, anti-inflammatory, and anti-pruritic activity. Notably, 78.2% of patients on seladelpar 10 mg versus 12.5% on placebo achieved the primary composite outcome after only 3 months (p<0.0001). In addition, 27.3% of patients on seladelpar 10 mg versus zero on placebo experienced normalization of ALP by 3 months (p<0.0001). Treatment with seladelpar 10 mg also resulted in a statistically significant improvement in pruritus (p<0.05) for patients with moderate-to-severe itch versus placebo. Overall, seladelpar appeared to be safe and well-tolerated in this study. * CymaBay intends to reinitiate the long-term study, a Phase 3 study and other NDA-enabling studies to confirm the potential of seladelpar to be a best-in-class treatment for patients with PBC and to further evaluate suitable strategies to advance seladelpar in other indications. * CymaBay held $168.9 million in cash, cash equivalents and short-term investments as of June 30, 2020 and had no outstanding debt. Cash and investments are deemed sufficient to fund CymaBay’s current operating plan into 2022. * Due to the ongoing effects of the global coronavirus pandemic, CymaBay continues to conduct its operations remotely for all employees, which has allowed business activities to continue as seamlessly as possible. To date, these developments have not had a significant impact on CymaBay’s financial condition or its ability to execute its business plan. CymaBay will continue to closely monitor pandemic developments and their associated risks to the business, including plans to restart clinical development of seladelpar, and will continue to take actions available to mitigate them where possible. Further, all CymaBay’s actions will be guided by a commitment to taking all steps possible to ensure the health and safety of its employees as well as patients enrolled in its clinical studies. Second Quarter and Six Months Ended June 30, 2020 Financial Results * Research and development expenses for the three months ended June 30, 2020 were $7.9 million, compared to $21.1 million for the three months ended June 30, 2019. Research and development expenses for the six months ended June 30, 2020 were $17.5 million, compared to $39.7 million for the six months ended June 30, 2019. Research and development expense in the three and six months of 2020 was significantly lower than the corresponding periods in 2019 primarily due to declining clinical trial activities related to the Phase 3 PBC, Phase 2b NASH, and Phase 2 PSC clinical trials, and other studies, as efforts continued to shut down these studies which were early-terminated as a result of the FDA’s clinical holds that were placed on the seladelpar program in the fourth quarter of 2019. * General and administrative expenses for the three months ended June 30, 2020 were $3.4 million, compared to $4.5 million for the three months ended June 30, 2019. General and administrative expenses for the six months ended June 30, 2020 were $7.7 million, compared to $10.2 million for the six months ended June 30, 2019. General and administrative expenses in the three and six months of 2020 were lower than the corresponding periods in 2019 due to lower employee compensation and other administrative expenses incurred as a result of a December 2019 reduction-in-force and restructuring effort that was undertaken to reduce costs in response to the FDA’s clinical holds on the seladelpar program. * Net loss for the three months ended June 30, 2020 was $10.7 million, or ($0.16) per diluted share, compared to a net loss of $24.0 million, or ($0.35) per diluted share in the three months ended June 30, 2019. Net loss for the six months ended June 30, 2020 was $23.8 million, or ($0.35) per diluted share, compared to a net loss of $47.1 million, or ($0.72) per diluted share in the six months ended June 30, 2019. Net loss was lower in the three and six months of 2020 compared to the corresponding periods in 2019 primarily due to a decrease in operating expenses, including clinical trial and labor related expenses, as a result of the early-termination of our seladelpar studies and our cost reduction efforts undertaken in response to the FDA’s clinical holds that were placed on the seladelpar program in the fourth quarter of 2019. Conference Call DetailsCymaBay will host a conference call today at 4:30 p.m. ET to discuss second quarter 2020 financial results and provide a corporate update. To access the live conference call, please dial 877-407-0784 from the U.S. and Canada, or 201-689-8560 internationally, Conference ID 13706143. To access the live and subsequently archived webcast of the conference call, go to the Investors section of the company's website at http://ir.cymabay.com/events.About CymaBay CymaBay Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet medical need. CymaBay is developing seladelpar, a potent, selective, orally active PPARδ agonist for patients with primary biliary cholangitis (PBC). Seladelpar has received an orphan designation from the US Food and Drug administration (FDA) and the European Medicine Agency (EMA). Seladelpar also received Breakthrough Therapy Designation from the FDA and PRIority MEdicines status from the EMA for PBC.Cautionary StatementsAny statements made in this press release and accompanying conference call regarding the potential for seladelpar to treat PBC and potentially improve clinical symptoms of the disease, the potential benefits to patients, CymaBay’s expectations and plans regarding its intended future interactions with the FDA, its current and future clinical trials and CymaBay’s ability to fund current and planned clinical trials are forward looking statements that are subject to risks and uncertainties. Actual results and the timing of events regarding the further development of seladelpar could differ materially from those anticipated in such forward-looking statements as a result of risks and uncertainties, which include, without limitation, risks related to: the success, cost and timing of any of CymaBay's product development activities, including clinical trials; effects observed in trials to date that may not be repeated in the future; any delays or inability to obtain or maintain regulatory approval of CymaBay's product candidates in the United States or worldwide; and the ability of CymaBay to obtain sufficient financing to complete development, regulatory approval and commercialization of its product candidates in the United States and worldwide or to potentially restart clinical trials. Additional risks relating to CymaBay are contained in CymaBay's filings with the Securities and Exchange Commission, including without limitation its most recent Annual Report on Form 10-K and other documents subsequently filed with or furnished to the Securities and Exchange Commission. CymaBay disclaims any obligation to update these forward-looking statements except as required by law.For additional information about CymaBay visit www.cymabay.com.Public Relations Contact: Glenn Silver Lazar-FINN Partners (973) 818-8198 Glenn.email@example.com Investor Relations Contact:Hans Vitzthum LifeSci Advisors, LLC (617) 430-7578 Hans@LifeSciAdvisors.com CymaBay Therapeutics, Inc. Financial Results (In thousands, except share and per share information) Quarter Ended Six Months Ended June 30, June 30, 2020 2019 2020 2019 (unaudited) (unaudited) (unaudited) (unaudited) Operating expenses: Research and development $7,942 $21,119 $17,451 $39,707 General and administrative 3,398 4,529 7,745 10,192 Restructuring charges (188) - (117) - Total operating expenses 11,152 25,648 25,079 49,899 Loss from operations (11,152) (25,648) (25,079) (49,899) Other income: Interest income 426 1,610 1,265 2,786 Total other income 426 1,610 1,265 2,786 Net loss $(10,726) $(24,038) $(23,814) $(47,113) Basic net loss per common share $(0.16) $(0.35) $(0.35) $(0.72) Diluted net loss per common share $(0.16) $(0.35) $(0.35) $(0.72) Weighted average common shares outstanding used to calculate basic net loss per common share 68,885,108 68,697,735 68,883,783 65,312,988 Weighted average common shares outstanding used to calculate diluted net loss per common share 68,885,108 68,697,735 68,883,783 65,312,988 CymaBay Therapeutics, Inc. Balance Sheet Data (in thousands) June 30, December 31, 2020 2019 (unaudited) Cash, cash equivalents and marketable securities $168,907 $190,945 Working capital 164,624 185,287 Total assets 176,597 205,727 Total liabilities 10,989 19,379 Common stock and additional paid-in capital 815,108 812,140 Total stockholders’ equity 165,608 186,348
The “dog days” of summer are here, but it’s just as busy as ever on the Street. As earnings results continue to roll in, investors will be watching for any update on the next economic stimulus package along with the non-farm payroll report slated for release this Friday. Against this backdrop, plenty of questions remain, weighing on the minds of both institutional and private investors.In a recent note to clients, Oppenheimer’s Chief Investment Strategist John Stoltzfus addresses these concerns. When it comes to stocks’ disconnected state, he writes that the market tends to focus on the future, with it betting on a successful outcome based on the stimulus policy already put in place. But will this highly accommodative monetary policy eventually cause inflation?“We do not expect high levels of inflation to result from the extraordinary stimulus and monetary policy taken to deal with the Covid-19 pandemic. Federal Reserve vigilance against inflation (as well as vigilance by central banks around the world) is likely to be able to suitably address any flare up of inflation,” Stoltzfus commented.Bearing this in mind, we took a closer look at three stocks backed by the analysts at Oppenheimer, the third best-performing research firm, according to TipRanks. Running the tickers through TipRanks’ database, we learned Oppenheimer sees at least 120% upside potential in store for each, and all three have earned a “Strong Buy” consensus rating from the rest of the Street.Durect Corporation (DRRX)Developing innovative therapies based on its endogenous epigenetic regulator program, Durect believes it could potentially transform the treatment of acute organ injury and chronic liver diseases. As one of its candidates has delivered encouraging results, Oppenheimer sees an opportunity to get in on the action.Firm analyst Francois Brisebois recently told clients, “After several years of promising results, we believe DRRX's endogenous small molecule epigenetic regulator DUR-928 has finally found its home in the treatment of Alcoholic Hepatitis (AH). Given a high level of mortality (26% 1-month rate) and no viable treatment options, we believe DUR-928's fairly early robust Phase 2a efficacy and safety data could have it attacking this ~ $3 billion market opportunity with peak penetration as early as 2025.”Digging a bit deeper into this Phase 2a data, along with a robust safety profile, the trial showed that the therapy was able to rapidly reduce bilirubin, a marker of AH. In addition, there was a 100% response to treatment from the Lille score (mortality predictor tool) in 30mg and 90mg dosages and reduction in MELD (AH severity). Going forward, AH Phase 2b is set to begin in 2H20. “Given the potential to receive Breakthrough Therapy Designation (BTD) for treating a life-threatening condition with a substantial improvement over available therapies (mainly corticosteroids), launch could happen ahead of anticipation. Additionally, market exclusivity and pricing could be greater if Orphan Drug Designation (ODD) is awarded based on ~117,000 annual hospitalizations,” Brisebois added.Plenty of other catalysts are still ahead, in Brisebois’ opinion. DUR-928 is being evaluated in hospitalized COVID-19 patients with acute liver or kidney injury in a Phase 2 study and Phase 1b NASH data could be released during an upcoming conference. It should also be noted that it’s a “waiting game” for Posimir’s PDUFA, with the analyst considering “any related weakness as a buying opportunity.”All of the above makes Brisebois optimistic about DRRX’s long-term growth prospects. As a result, the analyst continues to assign an Outperform rating and $7 price target to the stock. Should his thesis play out, a potential twelve-month gain of 202% could be in the cards. (To watch Brisebois’ track record, click here) Brisebois’ colleagues are also pounding the table on DRRX. Only Buy ratings, 4, in fact, have been issued in the last three months, so the consensus rating is a Strong Buy. At $6, the average price target implies shares could climb 156% higher in the next year. (See DRRX stock analysis on TipRanks)Avadel Pharmaceuticals (AVDL)Hoping to address overlooked and unmet medical needs, Avadel Pharmaceuticals wants to provide solutions through its patient-focused and cutting-edge products. With Oppenheimer stating its asset has “disruptive potential in a proven blockbuster market,” the firm believes it might be time to snap up shares. According to analyst Francois Brisebois, who also covers DRRX, AVDL is primarily focused on FT218, a once-nightly sodium oxybate designed for the treatment of narcolepsy patients suffering from excessive daytime sleepiness (EDS) and cataplexy. He goes so far as to call the candidate the company’s “first, second and third priorities,” noting that it recently sold its Hospital Drug Portfolio “to avoid distractions.”Looking at the pivotal Phase 3 REST-ON top-line data, Brisebois believes it “speaks for itself.” At the 9g dose, FT218 was able to produce a change from baseline in Maintenance of Wakefulness (MWT) of 10.82 minutes vs. 4.469 in placebo, in Clinical Global Impression-Improvement (CGI-I) of 72% vs. 31.6% and in Mean Weekly Cataplexy Attacks of -11.51 vs. -4.86, all three of the co-primary endpoints. “We were particularly impressed that the 6g and 7.5g doses also showed p<0.001 across all co-primary endpoints,” the analyst added.The implication? “Following strong efficacy and safety data, we believe FT218 could significantly disrupt Jazz Pharmaceuticals' Xyrem (twice-nightly sodium oxybate), which reported FY19 sales of $1.6 billion,” Brisebois said.While some investors have expressed concern regarding the company’s freedom to operate, Brisebois isn’t too worried. “We are comfortable with AVDL's freedom to operate path forward as we don't believe it will infringe on Xyrem's IP (REMS or DDI). Although FT218 does use the same drug substance, it consists of a substantially different drug product. The label should add more clarity,” he explained.Additionally, management has made a significant effort to drive a turnaround. Brisebois points out that since CEO Greg Divis was appointed in June 2019, he has offered clear guidance on enrollment, which has led to huge gains in the share price. He also mentioned, “Dr. Jordan Dubow's appointment as CMO was key because of his important role in adjusting the original study design (data a year ahead of expectations). New CFO Thomas McHugh's commercial experience is crucial.”Given everything that AVDL has going for it, it’s clear why Brisebois joined the bulls. In addition to initiating coverage with an Outperform rating, the analyst put a $19 price target on the stock. What does this mean for investors? Upside potential of 134% is at play.Overall, the bulls take the lead on this one. Out of 5 total reviews published in the last three months, all 5 analysts rated the stock a Buy. Therefore, the message is clear: AVDL is a Strong Buy. The $18.40 average price target implies shares could skyrocket 126% in the next twelve months. (See Avadel stock analysis on TipRanks)CymaBay Therapeutics (CBAY)Last but not least we have CymaBay Therapeutics, which develops therapies designed to improve the lives of patients with liver and other chronic diseases. Given its impressive technology, Oppenheimer has high hopes.Covering the stock for the firm, analyst Jay Olson points out that its seladelpar asset produced strong results in the ENHANCE Phase 3 study in PBC. As it was terminated early and there were only a small number of patients that reached 12 months, the primary endpoint was changed to 3 months. The revised primary composite and key secondary ALP normalization endpoints were both statistically significant at 10mg. “We believe these impressive efficacy results could set a new paradigm for physicians and patients as they strive to achieve ALP normalization,” the analyst commented.Going into more detail, 30% of patients in the study had moderate-to-severe pruritus, and the pruritus levels were balanced and representative of high-risk PBC patients, in Olson’s opinion. Unlike Ocaliva, which has a warning for severe pruritus with management strategies that include temporary dosing interruption, seladelpar was able to generate a substantial improvement in pruritus.Based on this promising data, CBAY could kick off a Phase 3 PBC study. “We expect CBAY to initiate this simplified Phase 3 PBC trial in 1Q21 with 12-month primary endpoint for pivotal data in 2023. The safety profile of seladelpar is similar to placebo and compares favorably to Ocaliva's which has a boxed warning for dosing in certain patients,” Olson stated.When it comes to the NASH indication, Phase 2b 52-week biopsy data, which showed a solid reduction in fibrosis and NASH resolution, could support seladelpar’s progression to Phase 3. It should be noted that CBAY might seek a partner here.With the company boasting a path forward in 2L PBC that could establish seladelpar as the standard of care, the deal is sealed for Olson. To this end, the analyst rates CBAY an Outperform (i.e. Buy) along with a $12 price target. This figure suggests 127.5% upside potential from current levels. (To watch Olson’s track record, click here) Looking at the consensus breakdown, other analysts echo Olson’s sentiment. With 8 Buys compared to no Holds or Sells, the word on the Street is that CBAY is a Strong Buy. In addition, the $12 average price target is identical to the Oppenheimer analyst’s. (See CBAY 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.Disclaimer: The opinions expressed in this article are solely those of the featured analysts. The content is intended to be used for informational purposes only. It is very important to do your own analysis before making any investment.