==Tupperware (TUP) takes action to improve capital structure and liquidity position

 

Tupperware takes action to improve capital structure and liquidity position

• Co announced it has engaged financial advisors to help improve its capital structure and remediate its doubts regarding its ability to continue as a going concern.
• The Company's Board of Directors is actively engaged with management to improve the Company's capital structure and near-term liquidity. The Company has engaged financial advisors to assist in securing supplemental financing, and is engaging in discussions with potential investors or financing partners. In addition, the Company is reviewing its real estate portfolio for property available for potential dispositions or sale-leaseback transactions, and is exploring right-sizing efforts, monetization of fixed assets, cash management, and marketing and channel optimization, to preserve or deliver additional liquidity.
• The Company has determined that a violation of its Credit Facility covenants is probable to occur as a result of the Company's delay in filing its Annual Report on Form 10-K for the year ended December 31, 2022 as well as cash constraints caused by higher interest costs and timing of re-engineering actions. Further, due to the challenging internal and external business economics, coupled with the increased levels and cost of borrowings under its Credit Facility, the Company currently forecasts that, if it is unable to obtain adequate capital resources or amendments to its Credit Agreement, it may not have adequate liquidity in the near term. As a result, the Company has concluded there is substantial doubt about its ability to continue as a going concern. This going concern status requires the Company to write-down certain non-cash deferred tax assets and goodwill and other intangible assets. Therefore, the financial results reflected in its Form 10-K, when filed, will differ significantly in these areas from the preliminary results it announced on March 1, 2023.

Athira (ATHA): Alzheimer's treatment did not meet endpoint in mid-stage trial

• The results indicated Athira's lead drug, ATH-1017, also called fosgonimeton, didn't have a statistically significant impact on working memory processing speed or cognition when compared with a placebo after 26 weeks.
 

 

 

 

Mark Litton, Athira's CEO, says the company is in a "fortuitous situation" despite the disappointing results.

ALX Oncology (ALXO) : Evorpacept Data Fails To Impress At ASH Presentation

• Announced initial data from the its Phase 1/2 ASPEN-02 study of evorpacept in combination with azacitidine for the treatment of patients with previously untreated higher-risk or relapsed or refractory myelodysplastic syndrome. The combination was well tolerated; among efficacy results, in six previously untreated HR MDS response-evaluable patients, three patients achieved an objective response and two achieved stable disease. Trades at record lows. 

 

 

 

-=Peloton (PTON) reported earnings on Thur 4 Nov 21 (a/h)

 

Peloton misses by $0.11, reports revs in-line; guides DecQ revs below consensus; guides FY22 revs below consensus; seeing a softer than anticipated start to DecQ

• Reports Q1 (Sep) loss of $(1.25) per share, $0.11 worse than the S&P Capital IQ Consensus of ($1.14); revenues rose 6.2% year/year to $805.2 mln vs the $808.87 mln S&P Capital IQ Consensus.
  • Q1 ending Connected Fitness Subscriptions grew 87% to 2.49 million and paid Digital Subscriptions grew 74% to 887 thousand; total Members grew to over 6.2 million.
• Co issues downside guidance for Q2 (Dec), sees Q2 revs of $1.10-1.20 bln vs. $1.49 bln S&P Capital IQ Consensus.
• Co issues downside guidance for FY22, sees FY22 revs of $4.40-4.80 bln vs. $5.35 bln S&P Capital IQ Consensus.
• "As discussed last quarter, we anticipated fiscal 2022 would be a very challenging year to forecast, given unusual year-ago comparisons, demand uncertainty amidst re-opening economies, and widely-reported supply chain constraints and commodity cost pressures. Although we are pleased to have delivered first quarter results that modestly exceeded our guidance, a softer than anticipated start to Q2 and challenged visibility into our near-term operating performance is leading us to recalibrate our fiscal year outlook.
• "The overall consumer environment has been very challenging to predict coming out of COVID and we are reducing FY 2022 ending Connected Fitness Subscriptions by ~6% at the midpoint. With the benefit of adequate inventories and order-to delivery windows that are now back to pre-pandemic levels, we expect a healthy holiday selling season. Our forecast assumes unit sales modestly ahead of last year's Q2 levels, driven by growing consumer interest in the Connected Fitness category and a resumption of our marketing and promotional activity."

Mannkind (MNKD): FDA declines to approve lung drug

 

 

 

Mannkind provides up on Tyvaso DPI NDA

• MannKind Corporation has learned that the FDA issued a complete response to United Therapeutics (UTHR) regarding the New Drug Application (NDA) for Tyvaso DPI for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease.
• The FDA declined to approve the NDA at this time, noting only one deficiency related to an open inspection issue at a third-party analytical testing center for treprostinil drug substance, the active ingredient of Tyvaso DPI. The complete response did not pertain to MannKind, and no issues were cited by the FDA as it relates to MannKind's facility in Connecticut for manufacturing, testing and packaging of finished Tyvaso DPI, including its associated device.

-=Yum China (YUMC) provides business update: Delta variant significantly impacted restaurant industry

 

Yum China provides business update: Delta variant impacted 16 provinces, significantly impacted the restaurant industry; adjusted operating profit expected to be reduced by 50-60% in Q3

• At the peak of the outbreak in August 2021, more than 500 stores in 17 provinces were closed or offered only takeaway and delivery services.
• Same-store sales in August 2021 declined by mid-teens percentage year over year, or close to an approximately -20% decline compared to August 2019.
  • This was mainly due to a same-store dine-in sales decline in that month of approximately -20% to -30%, and a sharp drop in sales at co's transportation and tourist locations of approximately -40% to -50% year over year, also on a same-store basis.
• While the outbreak has subsided in recent days and restaurant traffic is gradually recovering, operations continue to be heavily impacted, and the co expects a recovery of same-store sales to take time.
• Adjusted operating profit, which excludes special items, may be reduced by approximately 50% to 60% for the third quarter of 2021.
• Co added, "YUMC will accelerate its store network expansion, expecting to open 1,300 gross new stores in 2021, strengthen offerings for dine-in, delivery, takeaway and retail, and invest in digital and technology."

Coty (COTY) prices secondary offering

Coty prices secondary offering of 50,000,088 shares of common stock at $8.53 per share

• Shares of Class A common stock sold in the offering will be initially issued to KKR upon conversion of 285,576 shares of Coty's Series B Convertible Preferred Stock held by KKR.
  

 

Axsome Therapeutics (AXSM) : disappointing regulatory update for AXS-05

• Disappointing regulatory update for AXS-05 as a potential treatment for major depressive disorder (MDD).  
• Specifically, Axsome revealed during its 2021 second-quarter earnings release this morning that the U.S. Food and Drug Administration (FDA) had notified the company on July 30, 2021 that it has identified deficiencies within the drug's regulatory application that preclude discussion of labeling and post-marketing requirements at this time. A final decision on AXS-05's regulatory review for MDD is currently slated for Aug. 22, 2021.

 

 

 

The company announced that AXS-05 met the primary and key secondary endpoints in the Phase 2 MERIT trial and "substantially and statistically significantly prevented relapse of depressive symptoms compared to placebo in patients with treatment resistant depression." Co further stated, among various business updates, that as part of the ongoing review of its NDA for AXS-05, the FDA recently notified co that it has identified deficiencies that preclude labeling discussions at this time; the development may lead to a delay in the potential approval of AXS-05. Co also reported Q2 results. At 52-week lows.

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New York, NY-based Axsome Therapeutics (NASDAQ:AXSM) had its IPO on Nov 20, 2015 IPO. The stock opened at $9.00 on its first day of trading.

The clinical stage biopharmaceutical firm develops therapies for the management of pain and disorders of the central nervous system (CNS). Its lead product candidate is Phase 3-stage AXS-02 (disodium zoledronate tetrahydrate), a non-opioid therapeutic for chronic pain. The company is targeting three specific areas for development: complex regional pain syndrome, osteoarthritis of the knee associated with bone marrow lesions and chronic low back pain associated with Modic changes (changes in bones of the spine). Its second candidate is Phase 3-stage AXS-05, a fixed dose of combination of dextromethorphan and bupropion, for treatment-resistant depression and Alzheimer's disease-associated agitation.

Hoegh LNG Partners (HMLP) reduces quarterly cash distribution to $0.01/unit

• Cut its quarterly cash distribution to $0.01/unit from $0.44/unit, citing a need to conserve internally generated cash flows to resolve issues related to the ongoing refinancing of the PGN FSRU Lampung credit facility, which is not yet completed due to "failure by the charterer [...] to consent to and countersign certain customary documents related to the new credit facility." Downgraded at Barclays and B. Riley Securities. Drops to 52-week lows.
  

 

 

 

Hoegh LNG Partners reduces quarterly cash distribution to $0.01/unit from $0.44/unit 

• "The Partnership needs to conserve its internally generated cash flows to resolve issues related to the ongoing refinancing of the PGN FSRU Lampung credit facility as described below. The Partnership thereafter expects to use its internally generated cash flow to reduce debt levels and strengthen its balance sheet."
• "The ongoing refinancing of the PGN FSRU Lampung credit facility, which had been scheduled to close by the end of the second quarter of 2021, is not yet completed due to the failure by the charterer of the PGN FSRU Lampung to consent to and countersign certain customary documents related to the new credit facility."

-=SkyWater Technology (SKYT) : preliminary second-quarter results

 

Revenue in the second quarter is estimated to be in the range of $41 million to $41.5 million, while analysts were expecting the semiconductor company to generate $50 million in sales. That should result in a net loss of $7 million to $8 million, with an adjusted EBITDA loss of $500,000 to $1.5 million. SkyWater completed its IPO during the quarter, raising $112 million in capital.

SkyWater is planning to invest $56 million in order to expand manufacturing capacity of its gallium nitride (GaN) technology.

"These strategic investments evidence our commitment to our customers to co-create emerging technologies and help ensure we are in position to deliver long-term value to our shareholders," CEO Thomas Sonderman added. "We believe our investment in GaN technologies -- which expand possibilities for next generation microelectronics -- enhances SkyWater's position for leadership in the aerospace and defense, industrial and automotive markets."

-=Ardelyx (ARDX) : FDA questions its kidney disorder treatment drug

•  Company receives letter from the FDA identifying deficiencies in the NDA for tenapanor

Ardelyx receives letter from the FDA identifying deficiencies in the NDA for tenapanor that preclude discussions of labeling and post-marketing requirements/commitments at this time  

• Ardelyx received a letter from the FDA on July 13 stating that, as part of its ongoing review of the company's New Drug Application (NDA) for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis, the FDA has identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time. The letter stated that the notification does not reflect a final decision on the information under review.
  • Ardelyx is advancing tenapanor, a novel product candidate to control serum phosphorus in adult patients with CKD on dialysis, for which the company submitted an NDA to the FDA in June 2020. In April 2021, the FDA extended the PDUFA date to July 29, 2021, following the submission of additional analyses determined to be a major amendment.
• The company immediately requested a meeting to discuss the deficiencies and was notified by the FDA today that the request for a meeting was denied.
  • While the FDA has not provided specific details regarding the deficiencies, the FDA noted that a key issue is the size of the treatment effect and its clinical relevance.
  • The company plans to work with the FDA to learn more about the identified deficiencies and will seek to resolve them as quickly as possible.

=Uxin (UXIN) : financing transaction of up to US$315 million

 

Uxin entered into definitive agreements with NIO Capital and Joy Capital - agreed to invest a total of up to US$315 mln in the company

Concurrently, the Company has agreed with its convertible notes holders, including 58.com, TPG and Warburg Pincus, to convert their convertible notes in an aggregate principal amount of US$69 million into Class A ordinary shares of the Company. Over ten important investors, including NIO Capital, Joy Capital and the above mentioned convertible notes holders will agree not to sell their shares in the Company in the next nine months. The transaction is subject to customary closing conditions stipulated in the agreements.

-=Black Diamond Therapeutics (BDTX)

 

CAMBRIDGE, Mass. and NEW YORK, May 19, 2021 (GLOBE NEWSWIRE) -- Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a precision oncology medicine company pioneering the discovery and development of small molecule, MasterKey therapies, today announced initial data from the Phase 1 dose-escalation portion of the MasterKey-01 trial of BDTX-189 in patients with advanced solid tumors harboring any one of more than 48 oncogenic alterations in the epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2) oncogenes. These data provide early proof-of-concept for BDTX-189, including evidence of anti-cancer activity and a safety profile that is in-line with the Company’s preclinical expectations. The data announced today will be presented in poster presentations at the upcoming 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place June 4-8, 2021.

Once-daily (QD) dose escalation completed; pharmacokinetic (PK) profile consistent with design principles and preclinical predictions

Generally well-tolerated with medically manageable toxicities observed; safety profile compares favorably in the context of other agents in the class; preliminary recommended Phase 2 dose (RP2D) selected for the QD regimen

Preliminary anti-cancer activity observed in heavily pre-treated patients (prior EGFR/HER2-directed and/or I/O agents) in a variety of tumor types and genomic alterations in EGFR or HER2, including confirmed partial responses

Cara Therapeutics (CARA) : Korsuva fails for the treatment in atopic dermatitis (AD) patients

  

 

 

 

 

 

 

 

Cara Therapeutics announces topline results from its KARE Phase 2 dose-ranging clinical trial of Oral KORSUVA for the treatment of moderate-to-severe pruritus in mild-to-severe atopic dermatitis patients

Study did not meet Primary Endpoint of worst-itch NRS change from baseline at week 12 or Secondary Endpoint of 4-point responder analysis in the ITT patient population.

Study achieved Primary Endpoint of worst-itch NRS change and Secondary Endpoint of 4-point responder analysis in pre-specified analyses of mild-to-moderate AD patients (64% of ITT patient population).

Statistically significant improvement in 4-point responder analysis in mild-to-moderate (BSA <10%) AD patients with 32% of KORSUVA-treated patients achieving a > 4-point reduction vs. 19% in placebo group (p=0.03).

KORSUVA was well tolerated at all dose levels.

Protalix BioTherapeutics (PLX) receives Complete Response Letter for Pegunigalsidase Alfa from FDA

  

 

 

 

Protalix BioTherapeutics provides update on FDA Complete Response Letter for pegunigalsidase alfa (PRX-102) for the proposed treatment of adult patients with Fabry disease 

The CRL did not report any concerns relating to the potential safety or efficacy of PRX--102 in the submitted data package.

In the CRL, the FDA noted that an inspection of Protalix's manufacturing facility in Carmiel, Israel, including the FDA's subsequent assessment of any related findings, is required before the FDA can approve the BLA. Due to travel restrictions, the FDA was unable to conduct the required inspection during the review cycle. The FDA explained that it will continue to monitor the public health situation as well as travel restrictions, and is actively working to define an approach for scheduling outstanding inspections. With respect to the third-party facility in Europe at which fill and finish processes are performed for PRX-102, due to COVID--19, the FDA reviewed records in lieu of a pre-licensing inspection. In the CRL, the FDA stated that it will communicate remaining issues to the facility in order to seek prompt resolution of any pending items.

In addition to the foregoing, the FDA noted that Sanofi's (SNY) Fabrazyme was recently converted to full approval which must be addressed in the context of any potential resubmission seeking accelerated approval of PRX-102. Protalix intends to work collaboratively with the agency to identify the most expeditious pathway to approval, including accelerated approval. Protalix remains confident that it will be able to work with the FDA to resolve these issues and provide a new, alternative drug to Fabry patients. Protalix intends to request a Type-A meeting with the FDA, and will provide further updates on next steps after the meeting.

Arcturus Therapeutics (ARCT) : "underwhelming" coronavirus vaccine results

•  ARCT stock plunged 54.2% to 42.36 on Tue, Dec 30.

chart 1 week later

(Tue 12/30/20) The biotech company said late Monday it received approval from Singapore health officials to begin a Phase 2 study of its experimental Covid-19 vaccine. The study will enroll up to 600 volunteers and evaluate two dosing regimens of the drug.

In early-stage testing, the coronavirus vaccine — dubbed ARCT-021 — generated neutralizing antibodies after a single dose. However, the levels of antibodies were lower than other rival vaccines that were able to match or exceed the levels in people recovered from Covid-19.

Raymond James analyst Steven Seedhouse called the results "underwhelming." In a report to clients, he said the lower number of antibodies than expected "reduces our confidence that ARCT-021 will be able to achieve competitive levels of vaccine (effectiveness) with single-shot dosing."

In the early-stage test, the levels of antibodies in volunteers were largely below what vaccines from Moderna (MRNA) and Pfizer (PFE) with its partner BioNTech (BNTX) were able to generate. Those coronavirus vaccines are now authorized and rolling out in the U.S. and other countries.

Pfizer's vaccine is 95% effective and Moderna's is 94.1%, but Arcturus' drug might be only 62% effective at blocking Covid-19, Seedhouse said. Still, anything north of 60% would be a decent outcome for this type of vaccine, the ARCT stock analyst added.

Single-Shot Coronavirus Vaccine?

Like Pfizer and Moderna, Arcturus' vaccine uses messenger RNA technology. But the biotech company had been hoping to use a single shot, making it easier to administer. Both Pfizer's and Moderna's vaccines require two doses given several weeks apart.

-= Sarepta Therapeutics (SRPT) : Disappointing gene-therapy study results

 

Sarepta Therapeutics announces top-line results for Part 1 of Study 102; primary functional endpoint did not achieve statistical significance

Sarepta Therapeutics today announced top-line results from Part 1 of Study SRP-9001-102 (Study 102), an ongoing, randomized, double-blind, placebo-controlled clinical trial to evaluate the safety, efficacy, and tolerability of a single dose of SRP-9001 in 41 patients with Duchenne muscular dystrophy.

• SRP-9001 is an investigational gene transfer therapy intended to deliver its micro-dystrophin-encoding gene to muscle tissue for the targeted production of the micro-dystrophin protein.

At 12 weeks post-treatment compared to baseline, the study met its primary biological endpoint of micro-dystrophin protein expression.

• Participants who received SRP-9001 had mean micro-dystrophin expression of 28.1%, as measured by western blot.
• Accompanying secondary biological endpoints including vector genome copies per nucleus, percent positive fibers, intensity, and reduction in creatine kinase (exploratory) were also met.

In the primary functional endpoint, SRP-9001-treated participants showed an increase in NSAA total score compared to placebo at 48 weeks; however, the difference was not statistically significant.

• At every time point measured, the cohort of SRP-9001 treated participants outperformed the placebo group, and, at 48 weeks, participants in the treatment group demonstrated a statistically significant increase of 1.7 points in NSAA total score compared to baseline, while participants in the placebo group saw an increase of 0.9 points on the NSAA total score compared to baseline, which was not statistically significant.

In the pre-specified analysis by age-group, by which the randomization was stratified, participants aged 4-5 years at time of treatment with SRP-9001 demonstrated a statistically significant improvement in NSAA total score versus the age-matched placebo cohort, achieving a 4.3-point improvement on NSAA at 48 weeks post-treatment from baseline.

The results from Study 102 reinforce the "favorable" safety and tolerability profile of SRP-9001, with no new safety signals identified.

Penumbra (PEN) drops on short-seller note claiming fraud

• A short-seller charged in a report that Penumbra created a fake doctor to author research reports. The medical-device maker denies the claim.
• Quintessential Capital Management said the scientific literature produced by the medical-device maker  appeared to be authored by a "fake character." “This fraudulent character appears to have been fabricated by management in a reckless attempt to hide its involvement with critical research produced with significant undisclosed conflict of interest,” the report says.

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Gabriel Grego of Quintessential Capital Management speaking on CNBC 

In more than a dozen research papers over the past decade, an academic by the name of Dr. Antik Bose appeared to tout the reliability of catheters and other medical products made by Penumbra Inc. An internet search of Dr. Bose reveals a vivid character -- a billionaire medical researcher and hotelier with a taste for fine cars and homes. (source)

Quintessential says that photographs of a Dr. Antik Bose, the person claiming to author the reports, are either doctored or belong to unrelated persons. 

The firm's investigation into Bose's credentials also came to a dead end, according to Quintessential.

Penumbra responds to short seller report (source)

"Penumbra confirms the papers rumored to be attributed to Antik Bose are in fact attributed to Dr.Arani Bose. To imply that Dr. Arani Bose's peer-reviewed research, co-authored with a large cohort of his peers, was ever or would ever be attributed to anyone other than Dr. Arani Bose is inaccurate and conspiratorial. [...] These claims are baseless. Penumbra is reviewing its options of how to further respond."

-=FuelCell Energy (FCEL) drop as short-selling firm alleges it's lost contracts

 

Shares in FuelCell Energy (FCEL) dropped 10% as a short-selling company, Night Market Research, alleged the company lost two contracts in its backlog and didn't disclose that in a fundraising completed last week. The contracts in the backlog that allegedly were cancelled were with PSEG Long Island. Messages to both FuelCell Energy and PSEG Long Island weren't immediately returned. The stock has soared 488% over the last 12 months.

-=Zosano Pharma (ZSAN) received discipline review letter for Qtrypta NDA

 

Zosano Pharma receives discipline review letter from the FDA in connection Qtrypta NDA; approval of Qtrypta is not expected by the October 20 PDUFA date 

Zosano Pharma has received a discipline review letter (DRL) from the FDA in connection with the Qtrypta (zolmitriptan transdermal microneedle system) 505(b)(2) New Drug Application (NDA). A DRL is used by the FDA to convey preliminary comments on deficiencies identified during the NDA review with respect to a particular review discipline.

The DRL described two concerns with respect to the clinical pharmacology section of the NDA.

• First, the FDA raised questions regarding unexpected high plasma concentrations of zolmitriptan observed in five study subjects from two pharmacokinetic studies and how the data from these subjects affect the overall clinical pharmacology section of the application.
• Second, the FDA raised questions regarding differences in zolmitriptan exposures observed between subjects receiving different lots of Qtrypta in the company's clinical trials.

Although a DRL reflects preliminary comments that are subject to change, and does not reflect the FDA's final decision on the NDA, approval of Qtrypta by the Prescription Drug User Fee Act goal date of October 20, 2020 is not expected given the letter.