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Benzinga Briefs

Medicenna's MDNA55 Data From Mid-Stage Brain Cancer Study Published In Peer-Reviewed Clinical Cancer Research
  • Medicenna Therapeutics Corp (NASDAQ: MDNAannounced the peer-reviewed publication of clinical data from its Phase 2b trial evaluating MDNA55 in recurrent glioblastoma (rGBM).
  • The Phase 2b trial evaluated MDNA55, an interleukin-4 (IL-4)-guided toxin, as a treatment for rGBM, the most common and uniformly fatal form of brain cancer.
  • Results show that the median overall survival (OS) was 11.8 months, which is longer than what would be expected from the approved drugs carmustine (OS of 5.1 – 7.5 months), lomustine (OS of 7.1 – 9.8 months), or temozolomide (OS of 5.4 – 9.9 months).
  • Notably, the data also shows a potential link between patients experiencing radiographic progression and those exhibiting insufficient MDNA55 penetration into the tumor, suggesting that at least a portion of patients who did not respond well to MDNA55 may have benefited from higher drug concentrations.
  • These analyses supplement previously presented findings observed in Medicenna's proposed patient population showing an 81% tumor control rate (26/32) and a median OS of 15.7 months, which represents a >100% improvement compared to an external control arm (median OS of 7.2 months).
  • Medicenna is currently pursuing a partnership strategy to facilitate MDNA55's further development through the planned Phase 3 clinical trial.
  • Price Action: MDNA shares are up 5.4% at $3.7 during the market trading hours on the last check Friday.
AstraZeneca's Imfinzi, Tremelimumab Combo Boosts Overall Survival In Lung Cancer
  • A combination of AstraZeneca Plc's (NASDAQ: AZN) Imfinzi (durvalumab), tremelimumab, and chemotherapy has extended overall survival (OS) when used as a first-line treatment for stage IV (metastatic) non-small cell lung cancer (NSCLC).
  • A final analysis of data from the POSEIDON Phase 3 study shows that the combination demonstrated a statistically significant and clinically meaningful OS benefit versus chemotherapy alone.
  • The trial also tested a combination of Imfinzi plus chemotherapy, which, while showing a statistically significant improvement in progression-free survival (PFS) versus chemotherapy, failed to improve OS significantly.
  • Each combination demonstrated an acceptable safety profile, and no new safety signals were identified.
  • The data will be presented at a forthcoming medical meeting.
  • Price Action: AZN shares are up 0.62% at $53.81 during the market trading session on the last check Friday.
Acasti Pharma To Acquire Grace Therapeutics: Highlights
  • Acasti Pharma Inc (NASDAQ: ACSThas agreed to acquire privately-held Grace Therapeutics Inc in an all-stock transaction. After the consummation of the deal, Acasti would own approximately 55% of the combined company on a pro forma basis, and Grace would own the remaining 45%.
  • It is anticipated that the cash at closing of about $64 million will be principally used to pursue the clinical development of the first two assets through Phase 3.
  • Grace's drug development programs:
  • GTX-104 is an aqueous nanoparticle formulation of water-insoluble nimodipine under development for subarachnoid hemorrhage (SAH).
    • PK Bridging study results expected Q1 of FY2022; Phase 3 safety study expected to start enrollment in Q3 of FY2022.
  • GTX-102 an oral mucosal spray formulation of betamethasone for Ataxia-Telangiectasia.
    • PK study results are expected by the second half of next year. Phase 3 trial to study to start in the first half of 2023.
  • GTX-101 a topical bio-adhesive film-forming spray of bupivacaine for post-herpetic neuralgia.
    • Phase 1 results expected 2H'22; start of Phase 2 expected 2H'22.
  • Jan D'Alvise will lead the company entity as president and chief executive officer, and the corporation will continue to maintain its corporate headquarters in Laval, Quebec, Canada.
  • All Grace employees will transition to Acasti, and they will continue to maintain an R&D laboratory and commercial presence in North Brunswick, New Jersey.
  • The new Board of Directors will be composed of 4 representatives from Acasti and 3 from Grace.
  • The Proposed Transaction is expected to close in calendar Q3 of 2021
  • Acasti will take steps to regain compliance with Nasdaq's minimum bid price requirements in connection with the Proposed Transaction, and if required, would implement a share consolidation.
  • Oppenheimer & Co. is acting as Acasti's financial advisor. William Blair & Company, LLC is serving as financial advisor to Grace.
  • Price Action: ACST shares are up 18.5% at $0.48 during the market trading hours on the last check Friday.
Elanco Shares Rise After Q1 Earnings Exceed Expectations, Raises FY21 Outlook
  • Elanco Animal Health Inc (NYSE: ELAN) has reported Q1 EPS of $0.37 higher than $0.13 reported a year ago. It surpassed analysts' estimate of $0.23 and beat the company guidance of $0.20 – $0.25.
  • Sales of $1.24 billion were above the guidance range of $1.15 – $1.17 billion and beat the consensus estimate of $1.16 billion.
  • Total revenue increased 89% Y/Y driven by increased scale and diversification with the addition of Bayer Animal Health business.
  • Legacy Elanco revenue was $683 million, up 4% Y/Y. $559 million in sales came from the legacy Bayer Animal Health portfolio.
  • Pet Health revenue increased 213% to $645 million. Farm Animal revenue increased 33% for the quarter to $578 million.
  • Gross margin improved 480 basis points Y/Y to 54.2%.
  • Guidance Q2 2021: Elanco expects revenue of $1.225 – $1.255 billion, versus the analyst consensus of $1.16 billion.
  • It expects adjusted EPS of $0.22 – $0.27 in line with the consensus of $0.25 and adjusted EBITDA of $250 to $275 million.
  • FY2021: Elanco raised revenue guidance to $4.68 – $4.73 billion from $4.55 – $4.630 billion. Adjusted EPS outlook also raised to $1.00 – $1.06, up from the prior outlook of $0.90 – $1.00.
  • It forecasts adjusted EBITDA of $1.055 – $1.095 billion, higher than the previously guided range of $980 million – $1.040 billion.
  • Price Action: ELAN shares are up 6.4% at $33.02on the last check Friday.
Nkarta, CRISPR Join Forces On CAR-NK Development For Cancer
  • Nkarta Inc (NASDAQ: NKTX) has collaborated with CRISPR Therapeutics AG(NASDAQ:CRSP) to co-develop and commercialize two CAR-NK therapies, in addition to an NK+T program.
  • The companies will split all the R&D costs and any worldwide profits, 50/50.
  • CRISPR and Nkarta will start with a CAR-NK candidate targeting CD70 primarily for oncology indications. The target for their second CAR-NK program has yet to be revealed.
  • In addition to those programs, Nkarta can license CRISPR’s technology to edit five gene targets in an unlimited number of its own NK cell therapies.
  • For each non-collaboration candidate including a gene-editing target licensed from CRISPR, Nkarta will owe the company milestones and royalties on net sales.
  • The agreement includes a three-year exclusivity period between the companies.
  • Price Action: NKTX shares gained 8.96% at $20.18, while CRSP shares are up 2.62% at $110.67 on the last check Friday.
TRIP Stock Gains As CEO Expects Leisure Travel To Pick Up
  • TripAdvisor Inc (NASDAQ: TRIPreported a first-quarter FY21 revenue decline of 56% year-on-year to $123 million, beating the analyst consensus of $120.47 million.
  • Hotels, Media & Platform revenue declined 48% Y/Y to $88 million, Experiences & Dining revenue declined 66% Y/Y to $28 million, while Other revenue declined 73% Y/Y to $7 million.
  • Adjusted EBITDA loss was $26 million with a 21% margin, Experiences & Dining adjusted EBITDA loss was $24 million.
  • TRIP reported a Non-GAAP net loss was $53 million, with an adjusted EPS loss of ($0.39) missing the analyst consensus of ($0.32) loss.
  • TripAdvisor held $674 million in cash and equivalents and used $19 million in operating cash flow.
  • “Q1 demonstrated consumers want to get back out there and travel, CEO Steve Kaufer said. Traffic and revenue trends improved as vaccination rates climbed, particularly in the U.S. market, he added.
  • Kaufer believed that leisure travel was poised for a potential inflection later this year despite the uneven global recovery.
  • Price action: TRIP shares traded higher by 2.77% at $45.95 on the last check Friday.
APPN Stock Takes A Hit As Guidance Fails To Impress Wall Street
  • Appian Corp (NASDAQ: APPNreported first-quarter FY21 revenue growth of 13% year-on-year to $88.9 million, beating the analyst consensus of $82.7 million.
  • Cloud subscription revenue rose 38% Y/Y to $39.1 million, Total subscription revenue increased 26% Y/Y to $63.8 million, while Professional services revenue declined 12% Y/Y to $25.1 million.
  • Non-GAAP operating loss reduced 82.4% Y/Y to $0.9 million.
  • Non-GAAP net loss reduced 51.2% Y/Y to $4 million with an adjusted EPS loss of ($0.06), beating the analyst consensus of ($0.14) loss.
  • Adjusted EBITDA was $0.4 million versus a loss of $3.6 million in the year-ago period.
  • The company held $255.1 million in cash and equivalents and used $2.8 million in operating cash flow.
  • Guidance: Appian sees Q2 revenue of $77 million – $78 million, below the analyst consensus of $84.05 million, Cloud subscription revenue outlook of $41 million – $41.5 million.
  • It anticipates an EPS loss of ($0.26) – ($0.23), below the analyst consensus of ($0.16) loss.
  • FY21 revenue outlook of $353 million – $355 million falls short of the consensus of $355.44 million, with Cloud subscription revenue outlook of $171 million – $172 million. Non-GAAP EPS loss guidance of ($0.68) – ($0.65) falls short of the analyst consensus of ($0.59) loss.
  • Morgan Stanley maintains an Underweight on Appian and lowers the price target to $91.
  • Price action: APPN shares traded lower by 2.48% at $96.48 on the last check Friday.
NET Shares Are Trading Higher After Q1 Revenue Beat, Robust Q2, FY21 Guidance
  • Cloudflare Inc (NYSE: NETreported first-quarter FY21 revenue growth of 51% year-on-year to $138.1 million, beating the analyst consensus of $132.07 million. The dollar-based net retention rose 600 basis points Y/Y to 123%.
  • Non-GAAP gross margin contracted 70 basis points Y/Y to 77.6%, and Non-GAAP operating loss margin contracted 1,040 basis points Y/Y to 5.4%.
  • Non-GAAP net loss declined 24.4% Y/Y to $9.3 million, with an adjusted EPS loss of ($0.03) at par with the analyst consensus.
  • Cloudflare generated $23.5 million in operating cash flow and held $1 billion in cash and equivalents.
  • Guidance: Q2 revenue guidance lies between $145.5 million – $146.5 million, above the analyst consensus of $140.65 million. Non-GAAP EPS loss guidance lies between ($0.04) – ($0.03), versus the analyst consensus ($0.03) EPS loss.
  • Cloudflare sees FY21 revenue guidance lies between $612 million – $616 million, above the analyst consensus of $595.88 million, and adjusted EPS loss outlook of ($0.11) – ($0.10), versus the analyst consensus ($0.09) EPS loss.
  • Cloudflare crossed 4 million total customers, and its large customer count rose 70% Y/Y, accounting for over half of total revenue, CEO Matthew Prince said.
  • Price action: NET shares traded higher by 6.23% at $73.37 on the last check Friday.
OLED Beats On Q1 Earnings, Issues Robust FY21 Guidance
  • Universal Display Corp (NASDAQ: OLEDreported first-quarter FY21 revenue growth of 19.3% year-on-year to $134 million, beating the analyst consensus of $119.96 million.
  • Revenue from material sales rose 19.9% Y/Y to $79.8 million, Royalty and license fees revenue increased 18.1% Y/Y to $50.9 million, and Contract research services revenue rose 26$ Y/Y to $3.3 million.
  • Operating income rose 42.9% Y/Y to $63.6 million, with the margin expanding 780 bps Y/Y to 47.43%.
  • Net income rose 35.3% Y/Y to $51.7 million, with EPS of $1.08 beating the analyst consensus of $0.79.
  • Universal Display held $726.3 million in cash and equivalents and generated $29.5 million in operating cash flow.
  • It announced a Q2 dividend of $0.20 per share payable on June 30, 2021.
  • Guidance: OLED sees an FY21 revenue outlook of $530 million – $560 million, compared to the analyst consensus of $556.11 million.
  • Universal Display extended OLED Technology License and Material Purchase Agreements with LG Display Co Ltd (NYSE: LPL) and Visionox, and was jointly establishing a new manufacturing site in Shannon, Ireland with PPG Industries Inc (NYSE: PPG) for the production of UniversalPHOLED materials, since the last earnings call, CFO, Sidney D. Rosenblatt said.
  • The company has invested $700 million in R&D to advance from a start-up to a leading player in the global OLED ecosystem, Rosenblatt added.
  • Price action: OLED shares are up by 0.23% at $218.74 on the last check Friday.
Cronos Q1 Earnings Impacted By COVID-19 Related Restrictions
  • Cronos Group Inc (NASDAQ: CRONreported a Q1 adjusted EBITDA loss of $37.07 million, marginally up from $37.05 million reported a year ago.
  • This slight increase in losses was primarily driven by the rise in sales and marketing costs due to brand development in the U.S. segment and an increase in R&D costs.
  • Sales increased 50% Y/Y to $12.6 million, primarily driven by growth in the adult-use Canadian cannabis market, sales in the Israeli medical cannabis market, and increased sales in the U.S. segment driven by new U.S. hemp-derived CBD products introductions.
  • It was partially offset by strategic price reductions on various adult-use cannabis products in Canada in the second half of 2020.
  • Gross loss narrowed from $6.5 million inQ1 2020 to $2.9 million, also operating loss lowered to $43.5 million from $45 million a year ago.
  • Price Action: CRON shares are up 3.02% at $7.85 on the last check Friday.
Analysts React To FDA AdCom Vote On ChemoCentryx's Avacopan, Stock Plunges
  • Yesterday, the FDA’s Arthritis Advisory Committee panelists went through cloudy data while complaining about the design of the Phase 3 trial for ChemoCentryx Inc’s (NASDAQ: CCXI) avacopan. After going over time, they ended up without consensus.
  • This orphan drug has July 7 as its PDUFA date.
  • What do analysts have to say after the AdCom splits slightly in favor of FDA approving this rare disease drug:
  • Raymond James analyst Steven Seedhouse, on a reduced conviction in avacopan approval, downgraded the stock to Outperform from Strong Buy with the price target more than halved to $51 from $120.
    • However, if approved, Seedhouse still thinks avacopan is a blockbuster drug and will be adopted as a standard of care in ANCA vasculitis.
    • Seedhouse is not changing avacopan estimates (~$1.9 billion in peak sales), but now the probability of success stands at 50% vs. 100% prior.
    • He also notes that Avacopan should be approved and said, “we think certain AdCom panelists were unreasonable and unprepared.”
  • H.C. Wainwright analyst Edward White lowered the firm’s price target to $28 from $101 and kept a Buy rating on the stock.
    • White believes the mixed FDA panel opinion is negative for the drug’s potential approval and a significant negative for the stock.
    • White notes that in their opinion, the FDA does not have to follow the recommendations of the AdCom, but the attitude of the FDA before the meeting and during the meeting does not bode well for approval.
    • Sees the probability of success estimate at 15%, down from 85%.
  • SVB Leerink analyst Joseph Schwartz downgraded the firm stock to Market Perform from Outperform. 
    • Schwartz notes, “FDA briefing documents are surprisingly critical” and suggests that CCXI has an uphill battle to convince the AdCom that avacopan should be approved in ANCA-associated vasculitis.
  • Price Action: CCXI shares have dropped 61.7% at $10.53 during the premarket trading on the last check Friday.
Orphazyme Shares Plummet As Arimoclomol Flunks In Amyotrophic Lateral Sclerosis Study
  • Orphazyme A/S (NASDAQ: ORPH) has announced that the ORARIALS-01 pivotal trial of arimoclomol in amyotrophic lateral sclerosis (ALS) did not meet its primary and secondary endpoints.
  • No important safety signals were reported in the trial.
  • Topline data will be presented at the upcoming virtual European Network to Cure ALS meeting next week.
  • Complete data from the study will be published later this year.
  • The primary endpoint was to determine the efficacy of chronic treatment with arimoclomol compared to placebo in participants with ALS as assessed by the combined assessment of function and survival (CAFS).
  • Orphazyme’s applications for arimoclomol for Niemann-Pick disease type C (NPC) are under priority review with the FDA, with an expected PDUFA action date of June 17, as well as with the European Medicines Agency, with an opinion from the Committee for Medicinal Products for Human Use (CHMP) expected later this year.
  • In March, Arimoclomol failed to meet the primary and secondary endpoints in Phase 2/3 trial in inclusion body myositis patients.
  • Price Action: ORPH shares are down 28.7% at $6.10 on the last check Friday.
Enanta's EDP-514 Four-Week Treatment Shows Around 10 Time Reduction In Hepatitis B Virus RNA
  • Enanta Pharmaceuticals Inc (NASDAQ: ENTA) has announced data from the first two dose cohorts of Part 2 of its Phase 1b study evaluating EDP-514 in chronic hepatitis B virus (HBV) patients already being treated with a nucleoside reverse transcriptase inhibitor (NUC).
  • The data demonstrated that EDP-514, the Company's novel class II oral HBV core inhibitor, was safe and well-tolerated, displayed pharmacokinetics (PK) supportive of once-daily dosing, and resulted in a mean reduction in HBV RNA of 1 log.
  • A mean reduction in HBV RNA of 1 log (10 times) was observed in patients dosed with EDP-514 compared to 0.3 log (2 times) in the placebo group after 28 days of treatment, similar to reported results for other HBV core inhibitors.
  • A maximum reduction of 2.3 log (HBeAg-negative) and 2.8 log (HBeAg-positive) was observed in patients receiving EDP-514 compared with a maximum 1.2 log reduction in those receiving placebo.
  • The HBV DNA assessment did not show any change from baseline as these patients already had suppressed HBV DNA levels from NUC therapy. Additionally, no virologic failure or breakthrough was observed, and as expected, there were no changes in HBsAg, HBeAg, or HBcrAg levels.
  • EDP-514 was safe and well-tolerated, and pharmacokinetics were supportive of once-daily dosing.
  • EDP-514 exposure increased linearly with dose, achieving trough concentrations up to 18-fold the protein-adjusted EC50.
  • No liver enzyme elevations or other laboratory abnormalities were reported, and no serious adverse events occurred during the treatment period and the 4-week follow-up.
  • Price Action: ENTA shares are trading lower by 2.98% at $49.47 on the last check Friday.
YELP Anticipates Strong FY21 Performance After Better-Than-Expected Q1
  • Yelp Inc (NYSE: YELPreported a first-quarter FY21 net revenue decline of 7.1% year-on-year of $232.1 million, beating the analyst consensus of $228.41 million. The pandemic and shelter-in-place orders led to the slide.
  • Under the Advertising revenue category, Services revenue rose 5.7% Y/Y to $140.7 million, and Restaurants, Retail & Other revenue declined 24% Y/Y to $81.3 million. Transaction revenue rose 44.1% Y/Y to $3.8 million, while Other revenue declined 12.1% Y/Y to $6.3 million.
  • Yelp clocked a net loss of $6 million, with an EPS loss of ($0.08) better than the consensus of ($0.26) loss.
  • Adjusted EBITDA rose 159% Y/Y to $44 million, and margin expanded 1,200 basis points to 19%.
  • Yelp held $588.6 million in cash and equivalents and generated $58.9 million in operating cash flow.
  • It returned $99 million via share buybacks since Q1 FY20.
  • Guidance: Yelp raised FY21 net revenue guidance from $985 million – $1.005 billion earlier, to $1 billion – $1.02 billion, better than the analyst consensus of $998.18 million. 
  • Adjusted EBITDA guidance was raised from $150 million – $170 million to $175 million – $195 million.
  • Price action: YELP shares traded lower by 0.47% at $38.05 on the last check Friday.
  • Image Courtesy: Wikimedia
Pandemic Hits Groupon's Revenue But It Contains Costs, Beats Wall Street Consensus
  • Groupon Inc (NASDAQ: GRPNreported a first-quarter FY21 revenue decline of 29.5% year-on-year to $263.8 million, beating the analyst consensus of $225 million.
  • Revenue from Local declined 22.4% Y/Y to $148.6 million, Revenue from Travel declined 30% Y/Y to $6.8 million, and Revenue from Goods declined 37.3% Y/Y to $108.4 million.
  • Global units sold declined 40% Y/Y to 18 million due to the pandemic. North America units declined 42% in Local and 18% in Goods, International units declined 69% in Local and 8% in Goods.
  • Local Gross Billings fell36.2% Y/Y to $350.97 million, Goods Gross Billings fell 14.2% at $168.08 million, and Total Gross Billings fell 31.3% Y/Y at $553.97 million.
  • The company reported a non-GAAP net income of $7.5 million against a $46.2 million loss in the year-ago period.
  • Non-GAAP EPS of $0.25 was not comparable to the consensus of $0.58 loss.
  • Adjusted EBITDA rose 35.1% Y/Y to $30.4 million.
  • Groupon generated $126.4 million in operating cash flow and held $676.8 million in cash and equivalents. It also raised $200 million from a convertible debt offering in March.
  • Guidance: Groupon sees FY21 revenue of $950 million – $990 million, compared to the analyst consensus of $966.26 million and Adjusted EBITDA outlook of $110 million – $120 million.
  • Groupon continued to execute on the plan to significantly reduce cost structure this year, which positioned it to deliver substantial Adjusted EBITDA if the business returned to just 80% of 2019 gross profit levels and made notable progress executing on growth strategy, including the recent launch of new customer experience, CEO Aaron Cooper said.
  • Price action: GRPN shares closed lower by 3.59% at $48.94 on Thursday.
  • Image Courtesy: Wikimedia