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Monday, April 1, 2024

ZimVie Announces Closing of Sale of Spine Business

 ZimVie Inc. (Nasdaq: ZIMV), a global life sciences leader in the dental market, today announced that it has closed the previously communicated sale of its Spine business to an affiliate of H.I.G. Capital for $375 million in total consideration, including $315 million in cash and a $60 million promissory note.

“The completion of the sale of our Spine business is the culmination of months of partnership with H.I.G. Capital and years of commitment from our global Spine team members; I would like to thank everyone for their immense contributions,” said Vafa Jamali, President and Chief Executive Officer. “I could not be more excited for the future of our company as we continue to invest in differentiated solutions for Dental patients and providers in our most attractive end markets, while optimizing our structure to deliver value for our shareholders.”

Terms of the Agreement

Under the terms of the agreement, ZimVie will receive $375 million in total consideration, comprised of $315 million in cash, subject to certain customary adjustments as set forth in the agreement, and $60 million in the form of a promissory note that will accrue interest at a rate of 10% per annum, compounded semi-annually, payable in kind, subject to a maturity no later than five and a half years from today’s closing.

Outlook for ZimVie

As previously communicated, ZimVie expects to achieve an annualized financial profile of $455+ million in Net Sales, and a 15%+ adjusted EBITDA margin(1) one year following the close of the deal. ZimVie intends to immediately pay down $275 million of outstanding debt, leaving total debt of approximately $234 million, and estimated cash of approximately $66 million as of April 2, 2024.

https://www.globenewswire.com/news-release/2024/04/01/2855117/0/en/ZimVie-Announces-Closing-of-Sale-of-Spine-Business.html

Solid Biosciences Receives Rare Pediatric Disease Designation for Duchenne

  SGT-003 Granted Rare Pediatric Disease, Orphan Drug and Fast Track Designations in U.S. –

– Site initiations scheduled for April; patient dosing expected to begin in Q2 2024 –

https://www.globenewswire.com/news-release/2024/04/01/2855112/0/en/Solid-Biosciences-Receives-Rare-Pediatric-Disease-Designation-from-the-FDA-for-Duchenne-Muscular-Dystrophy-Gene-Therapy-Candidate-SGT-003.html

Eiger Biopharmaceuticals Files for Chapter 11

  Eiger Biopharmaceuticals Inc., a company developing therapies for rare metabolic diseases, has filed for bankruptcy.

Publicly traded Eiger listed about $38.8 million in assets and $53.1 million in liabilities in a Chapter 11 petition filed Monday in Dallas. The bankruptcy filing will give Eiger time to discuss restructuring options with its creditors.

The stock fell as much as 51% after Bloomberg reported the filing. In bankruptcy, equity is last in line for repayment and shareholders are usually wiped out.

Eiger, based in Palo Alto, California, filed Chapter 11 after its board of directors explored other financing options including searching for equity financing, according to court documents. The company said it develops therapies for hepatitis delta virus and other serious diseases.

Eiger said in court papers it will attempt to sell its assets in Chapter 11.

https://finance.yahoo.com/news/eiger-biopharmaceuticals-files-chapter-11-142653525.html

Disc Medicine Plummets 59% After Placebo Effect Confounds Sunlight Sensitivity Study

 Disc Medicine's (IRON) light sensitivity treatment succeeded in a midstage study Monday, but an outsized placebo response confounded the results and the biotech stock plummeted.

The biotech company is trying to treat erythropoietic protoporphyria, a rare condition in which a toxic substance called protoporphyrin IX builds up in the blood. Patients experience severe reactions in the sunlight, including pain, swelling, burning sensations, blistering and disfigurement.

After 17 weeks, patients who received Disc's drug, bitopertin, had statistically significant reductions in protoporphyrin IX.

But the secondary goal of the study — time spent in the sunlight without pain — wasn't statistically significant due to a "greater than expected" response from the placebo group, Disc said in a news release. On average, low-dose and high-dose patients spent 175.1 hours and 153.1 hours in the sunlight without pain, respectively. Placebo patients reached 133.9 hours.

In premarket trades on today's stock market, Disc stock crashed 59.4% to 25.30. 

https://www.investors.com/news/technology/biotech-stock-disc-medicine-light-sensitivity-aurora-study/

Akari merger and year end update

 Akari announced the company has reached a definitive agreement with Peak Bio Inc. (Peak Bio) to merge as equals in an all-stock transaction. The combined entity will operate as Akari Therapeutics, Plc, which is expected to continue to be listed and trade on the Nasdaq Capital Market as AKTX.

Following closing, the company will have an expanded pipeline that contains multiple compelling assets spanning early and late development stages, including: a robust antibody drug conjugate (ADC) toolkit with novel payload and linker technologies, a Phase 2-ready neutrophil elastase inhibitor (NEI) program targeting alpha-1 antitrypsin deficiency (AATD), nomacopan, a bispecific inhibitor of two immune pathways (complement C5 and leukotriene B4/LTB4) in Phase 3 development for pediatric hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA), and long-acting PAS-nomacopan for geographic atrophy (GA).

A strategic assessment of the pipeline is planned to evaluate development of the four programs including program prioritization, updated timelines, near-term value creation opportunities, and other considerations. The assessment is expected to be complete prior to the closing of the merger.

The Phase 3 Part A clinical trial of investigational nomacopan in pediatric HSCT-TMA is studying multiple age groups with a focus on PK/PD and dose confirmation. Akari is continuing to recruit patients into the Part A portion of the Phase 3 clinical trial that has treated 10 patients to date. Enrollment in Part A is guided by new consensus criteria published in 2023 supporting earlier screening and diagnosis of high-risk (severe) patients with HSCT-TMA. The Phase 3 clinical trial also is expected to include a Part B portion focusing on safety and efficacy. Plans for initiation of the Part B study will be guided by the strategic pipeline assessment.

HSCT-TMA is a rare complication of stem cell transplant that has no approved treatment options and an 80% mortality rate among severe patients. Nomacopan is in development as potentially the first treatment approved for the condition.

Akari was granted orphan drug designation from the European Commission for treatment in hematopoietic stem cell transplantation, and FDA Orphan Drug, Fast Track and Rare Pediatric Disease designations for nomacopan for the treatment of pediatric HSCT-TMA. With the FDA Rare Pediatric Disease Designation, Akari is eligible to receive a Priority Review Voucher (PRV) upon approval of nomacopan that it can either redeem for priority review of a subsequent marketing application for a different product or sell to a third party. 

During 2023, Akari also advanced the long-acting version of nomacopan (PASylated nomacopan) into the final stages of pre-clinical development as a treatment for geographic atrophy (GA). PAS-nomacopan is being developed with the potential to address significant unmet patient needs, including a longer dose interval between intravitreal injections and reduction of choroidal neovascularization (CNV) risk associated with approved complement-only inhibitors currently used for treatment of GA. Positive pre-clinical results, including an advanced high-yielding manufacturing process that provides a drug with specifications considered suitable for intravitreal administration, support the potential initiation of clinical development with Phase 1 single and multiple ascending dose (SAD/MAD) testing to evaluate safety and pharmacokinetics/ pharmacodynamics (PK/PD). A progressive and sight-threatening condition, GA is estimated to affect 5 million people worldwide, including 1 million patients in the U.S.

Full-Year 2023 Financial Results

As of December 31, 2023, the company had cash of approximately $3.8 million. In March 2024, the company received approximately $2.0 million in gross proceeds from certain existing investors from the sale of ADSs in a private placement and is planning to secure additional capital in the second quarter of 2024.

Research and development expenses were approximately $5.5 million for the year ended December 31, 2023, as compared to approximately $9.6 million for the same period in 2022.

General and administrative expenses were approximately $11.4 million for the year ended December 31, 2023, as compared to approximately $13.5 million for the same period in 2022.

Total other income, net was approximately $6.8 million for the year ended December 31, 2023, as compared to approximately $5.3 million for the same period in 2022, of which $6.6 million and $5.0 million (net) was the result of net non-cash gains related to the company's liability-classified warrants issued in connection with the company's September 2022 private placement transaction.

Net loss was approximately $10.0 million for the year ended December 31, 2023, as compared to net loss of approximately $17.7 million for the same period in 2022. Excluding the net non-cash gains of approximately $6.6 million and $5.0 million (net) for the years ended December 31, 2023 and 2022, respectively, related to the company's liability-classified warrants, net loss was $16.6 million and $22.7 million, respectively.

https://www.globenewswire.com/news-release/2024/04/01/2855059/0/en/Akari-Therapeutics-Reports-Full-Year-2023-Financial-Results-and-Recent-Highlights.html

Sunshine Biopharma Results

 Sunshine Biopharma Inc. (NASDAQ:SBFM) (the "Company"), a pharmaceutical company offering and researching life-saving medicines in a variety of therapeutic areas including oncology and antivirals today announced that it has filed its 2023 financial results on Form 10-K on Thursday March 28, 2024. The following are highlights of the report:

  • Sales in 2023 grew to a total of $24,092,787, primarily as a result of a full year of revenues generated by the acquisition of Nora Pharma in October 2022. Nora Pharma's revenues for its fiscal year ended June 30, 2022, were $10,766,982.
  • The average 2023 quarter-over-quarter growth rate in sales was 14%.
  • Loss per share decreased from a negative $1.76 per share in 2022 to a negative $0.19 per share in 2023, predominantly due to a one-time write-off of goodwill in 2022.
  • Completed a private placement of approximately $5 million in gross proceeds for use in part for expansion of sales operations.
  • Repurchased 513,723 shares of the Company's common stock on the market for a total of $541,143.
  • The Company's two proprietary drugs in development advanced to the animal testing stage for both SBFM-PL4 targeted for SARS Coronavirus infections and K1.1 mRNA for liver cancer.
  • IND-enabling studies of Adva-27a anticancer compound were halted in November 2023 pending further analysis of unfavorable in vitro results obtained earlier in the year.

"We are happy with our 2023 results, as we continue to strive to achieve profitability," said Dr. Steve Slilaty, CEO of Sunshine Biopharma. "We look forward to further growth in 2024 and beyond as we expand our operations and bring more life-saving drugs to market," he added.

https://www.accesswire.com/848518/sunshine-biopharma-reports-operating-results-for-the-fiscal-year-ended-december-31-2023

Russian military intelligence unit may be linked to 'Havana syndrome': reports

 The mysterious "Havana syndrome" ailment that has afflicted U.S. diplomats and spies across the world may be linked to energy weapons wielded by members of a Russian military intelligence sabotage unit, the Insider media group reported.

A U.S. intelligence investigation whose findings were released last year found that it was "very unlikely" a foreign adversary was responsible for the ailment, first reported by U.S. embassy officials in the Cuban capital Havana in 2016.

But Insider, a Russia-focused investigative media group based in Riga, Latvia reported that members of a Russian military intelligence (GRU) unit known as 29155 had been placed at the scene of reported health incidents involving U.S. personnel.

The year-long Insider investigation in collaboration with 60 Minutes and Germany's Der Spiegel also reported that senior members of Unit 29155 received awards and promotions for work related to the development of "non-lethal acoustic weapons".

Russia has previously denied any involvement.

Symptoms of the ailment have included migraines, nausea, memory lapses and dizziness.

The Insider report said the first incident of "Havana Syndrome" symptoms may have happened earlier than 2016.

It said "there were likely attacks two years earlier in Frankfurt, Germany, when a U.S. government employee stationed at the consulate there was knocked unconscious by something akin to a strong energy beam".

U.S. Congress passed the Havana Act in 2021 authorising the State Department, CIA and other U.S. government agencies to provide payments to staff and their families who have been affected by the ailment during assignment.

https://www.yahoo.com/news/russian-military-intelligence-unit-may-060223890.html