Mereo Update on Pipeline Progress and Corporate Developments

 Phase 3 portion of Orbit Study and Phase 3 Cosmic Study of setrusumab for treatment of Osteogenesis Imperfecta (OI) conducted by partner Ultragenyx expected to complete enrollment around the end of 1Q 2024 and 1H 2024, respectively; Additional Phase 2 data expected in 2024

Alignment on design for single, global Phase 3 study of alvelestat in Alpha-1 Antitrypsin Deficiency-associated Lung Disease (AATD-LD) following additional interactions with U.S. FDA in 2H 2023

Signs global licensing deal for development and commercialization of leflutrozole

Reiterates previous cash runway guidance; current cash expected to fund operations into 2026

https://www.globenewswire.com/news-release/2024/01/08/2805293/0/en/Mereo-BioPharma-Provides-Update-on-Pipeline-Progress-and-Corporate-Developments.html

Corcept financial update, share buyback

 

• Fourth quarter revenue of $135.4 million, a 31 percent increase
  over the same period in 2022
• Full year 2023 revenue of $482.4 million, a 20 percent increase over 2022
• 2024 revenue guidance of $600 – $630 million
• Cash and investments of $425.4 million as of December 31, 2023
• Announcement of $200 million stock repurchase program

https://www.globenewswire.com/news-release/2024/01/08/2805399/0/en/Corcept-Therapeutics-Provides-Financial-Update-and-Announces-Stock-Repurchase-Program.html

Neuronetics prelims

 Fourth Quarter 2023

Preliminary unaudited total revenue is expected to be over $20 million as compared to previously stated guidance of $19.0 to $21.0 million.

Preliminary unaudited U.S. NeuroStar Advanced Therapy System revenue is expected to be approximately $4.5 million. In the quarter, the Company shipped 59 systems.

Preliminary unaudited U.S. Treatment Session revenue is expected to be over $14.5 million a Company record, and an increase of approximately 20% over the fourth quarter of 2022.

Local consumable revenue increased by over 33% over the fourth quarter 2022.

The Company generated positive cash flow of over $1 million in the fourth quarter 2023, ending 2023 with cash and cash equivalents at approximately $59 million.

Full Year 2023

Preliminary unaudited total revenue is expected to be over $71 million as compared to previously stated guidance of $70.0 to $72.0 million.

“2023 was an exciting year at Neuronetics. The momentum we built throughout the year resulted in a record fourth quarter. From a commercial perspective, we are seeing sustained improvement in utilization trends across key customer segments. Our local consumable customers grew utilization by over 20% and Greenbrook has continued to drive increasing usage of NeuroStar,” said Keith J. Sullivan, President and Chief Executive Officer of Neuronetics. “Importantly, our growth, in combination with increased operating leverage and our prudent expense management generated positive cash flow of over $1 million in the fourth quarter, a significant milestone for the company,” added Mr. Sullivan.

Mr. Sullivan concluded, “As we look to 2024, we are very enthusiastic about our opportunity to continue to expand the widespread use of NeuroStar. We are particularly excited about the launch of the next phase of our Better Me Guarantee Provider pilot program in January of 2024. We have approximately 100 customer sites who will be included in the next cohort which begins on January 22, and over 275 sites who are on track to be eligible to participate in the next phase of the pilot program later in 2024. Practices accepted into the BMGP pilot agree, and are required, to meet specific standards of patient care and responsiveness, which we believe will help identify patients in need who would benefit from NeuroStar.”

https://www.globenewswire.com/news-release/2024/01/08/2805448/0/en/Neuronetics-Reports-Preliminary-Fourth-Quarter-and-Fiscal-Year-2023-Financial-Results.html

Standard BioTools prelims

 Standard BioTools Inc. (Nasdaq: LAB) (Standard BioTools or the Company), driven by a bold purpose – Unleashing tools to accelerate breakthroughs in human health, today announced Standard BioTools and SomaLogic, Inc. preliminary and unaudited revenue results for the fourth quarter and full year 2023.

Standard BioTools expects fourth quarter 2023 revenue of approximately $28 million and full year 2023 revenue of approximately $106 million. The Company’s preliminary full year 2023 revenue results represent growth of over 10% in core revenue1 driven by over 40% growth in instrument revenue, in each case as compared with 2022.

SomaLogic expects fourth quarter 2023 revenue of approximately $23 million and full year 2023 revenue of approximately $86 million.  

As previously announced, Standard BioTools completed its merger with SomaLogic on January 5, 2024. Standard BioTools expects cash, cash equivalents and short-term investments of the combined company to be over $550 million as of December 31, 2023, on a pro forma condensed combined basis.

Michael Egholm, PhD, President and Chief Executive Officer of Standard BioTools, said, “With steadfast operating discipline, we continue to make important progress executing against our long-term strategic transformation plan, and we are excited to move forward as a combined company with SomaLogic. We are pleased that both companies delivered annual revenues above our stated targets, which we achieved in a challenging macroenvironment, and remain committed to building a scalable, profitable suite of differentiated life science tools and accelerating breakthroughs in health care.”

Standard BioTools expects to report its fourth quarter and full year 2023 results in early March, at which time the Company will discuss its 2023 financial results in more detail and provide its outlook for 2024.

https://www.globenewswire.com/news-release/2024/01/08/2805468/0/en/Standard-BioTools-Announces-Preliminary-Fourth-Quarter-and-Full-Year-2023-Revenue.html

Prothena Updates on PRX012, PRX123, Birtamimab and Portfolio Programs

 

• Updates on PRX012 and PRX123 for treatment of Alzheimer’s disease, and on birtamimab for treatment of AL amyloidosis
• Remain on track with partnered programs: Bristol Myers Squibb (BMS-986446 for the treatment of Alzheimer’s disease), Roche (Prasinezumab for the treatment of Parkinson’s disease) and Novo Nordisk (NNC6019 for the treatment of ATTR amyloidosis)

• Prothena remains well financed with cash, cash equivalents, and restricted cash of approximately $621 million at year end 2023, providing sufficient capital beyond the completion of its ongoing clinical trials

https://www.businesswire.com/news/home/20240108622841/en/

Maersk, Hapag-Lloyd Deny Reported Safe Passage Deal With Houthis

 

A.P. Moller - Maersk A/S and Hapag-Lloyd AG denied any pact with Yemen’s Houthi rebels to facilitate the safe movement of vessels through the Red Sea, after shares in shipping companies sunk on a report of deals being struck.

Container company stocks were hit by a report in Danish publication ShippingWatch that said meetings between Houthi rebels and shipowners had taken place, and that some safe passage accords had already been agreed upon. The publication didn’t name the companies that had purportedly made the pacts.

https://www.bloomberg.com/news/articles/2024-01-08/shipping-stocks-drop-after-report-of-pacts-with-houthi-rebels

Akoya prelims, guidance

Akoya Biosciences, Inc. (AKYA) said it expects fourth quarter revenue to be between $25.5 million and $26.5 million, as compared to $21.2 million a year ago. For fiscal 2023, the company expects revenue to be between $95.6 million and $96.6 million, as compared to $74.9 million, last year. Year end 2023 projected cash, cash equivalents, and restricted cash balance is between $83.0 million and $85.0 million.

Brian McKelligon, CEO, Akoya Biosciences, said: "Throughout 2023, we delivered strong financial performance on the topline while maintaining operating expenses at a steady level, bolstering our confidence in achieving cash flow positivity earlier than previously projected."

Akoya Biosciences expects 2024 revenue to grow more than 20% and projects achieving operating cash flow breakeven by year end 2024.

https://www.rttnews.com/3415100/akoya-biosciences-issues-preliminary-revenue-results-issues-2024-guidance.aspx