Search This Blog

Thursday, June 27, 2019

Acasti Pharma Trades Higher Despite ‘Material Uncertainty’

Shares of biopharmaceutical company Acasti Pharma Inc ACST 2.5% were trading higher Wednesday after the biopharmaceutical company issued a fiscal 2019 year-end business update.

What Happened

Acasti, a biopharma innovator focused on the treatment of severe hypertriglyceridemia (HTG), said in a business update that fiscal 2019 was “eventful.”
The company recorded milestones related to its Phase 3 clinical trials and achieved 100% patient randomization in the TRILOGY clinical trials.
Acasti’s loss for fiscal 2019 expanded from $21.5 million in the prior year to $51.6 million due to higher R&D costs for the TRILOGY Phase 3 program and other financial expenses.
The company ended the year with $34.4 million in cash — $26.2 million more than than the prior year on the basis of net proceeds from public offerings in May and October.

Why It’s Important

Despite ending the year with more cash on the balance sheet year-over-year, Acasti said it will need to raise additional capital in the future to complete the funding of its NDA preparations for a U.S. commercial launch.
If the company is not able to raise the necessary funds, it “may not be able to realize its assets and discharge its liabilities in the normal course of business.”

What’s Next

Acasti said “there exists a material uncertainty about Acasti’s ability to continue as a going concern” in the press release.

FDA Lifts Clinical Hold On Translate Bio’s Liver Disorder Trial

Shares of the clinical-stage mRNA therapeutics company Translate Bio Inc TBIO, which went public in June 2018, were showing some strength Wednesday.

What Happened

Translate Bio said Wednesday that the FDA has given its clearance to proceed with a single-ascending dose, or SAD, Phase 1/2 clinical trial of MRT5201 in patients with ornithine transcarbamylase, or OTC, deficiency.
The investigational asset acts by intravenous delivery of mRNA that encodes the fully functional OTC enzyme to the liver to enable the hepatocytes to produce normal OTC enzymes.
OTC deficiency is a metabolic liver enzyme disorder resulting from a mutation in the OTC gene; it causes toxic levels of ammonia to build up in the blood.
Following the submission of an IND for MRT5201 in December, the FDA placed a clinical hold on the trial pending additional preclinical toxicology data.
The company subsequently had discussions with the FDA and amended the protocol, paving the way for the lifting of the clinical hold and the go-ahead for the the SAD trial.

What Next

TranslateBio said it is conducting additional preclinical studies to support future clinical development of MRT5201, including a multiple ascending dose clinical trial.
The company expects to submit data from these studies to the FDA in the fourth quarter of 2019.

Quanterix scoops up Uman Diagnostics for $22.5M

Quanterix (NASDAQ:QTRXagrees to acquire privately held Uman Diagnostics for $22.5M, comprised of $16M in cash and $6.5M in Quanterix shares
Uman possess antibodies to measure neurofilament light (Nf-L), and the acquisition positions Quanterix to capitalize opportunities with Nf-L applications in Alzheimer’s Disease, Multiple Sclerosis, and other neuro-degenerative conditions
The transaction is expected to provide 200 bps of annualized company gross margin improvement.

BridgeBio Pharma prices its IPO at $17, above the high end of the range

BridgeBio Pharma (BBIO) has priced its initial public offering of 20.5M common shares at $17.
Underwriters over-allotment is an additional 3.075M  common stock.
The shares are expected to begin trading on the Nasdaq on June 27 under the ticker symbol “BBIO”
Closing date is July 1.
Source: Press Release

Morphic prices upsized IPO at $15

Morphic Holding (NASDAQ:MORF) has priced its upsized IPO of 6M  common shares at $15, for gross proceeds of $90M.
Underwriters over-allotment is an additional 0.9M common shares.
The shares are expected to begin trading on Nasdaq on June 27 under the symbol “MORF.”
Closing date is July 1.
Source: Press Release

Change Healthcare prices IPO and tangible equity units

Change Healthcare (CHNG) has priced its IPO of 42.86M common shares at $13.00 per share and its concurrent offering of 5M of its 6.00% tangible equity units with a stated amount of $50.
Closing date is July 1.
Underwriters over-allotment is an additional 6.43M common shares and 0.75M units.
The shares and the units are expected to begin trading on the Nasdaq on June 27 under the symbols “CHNG” and “CHNGU,” respectively.
Net proceeds from both offering will be used to repay a portion of the outstanding indebtedness under its senior secured term loan facility.
Source: Press Release

Adaptive Biotechnologies prices IPO at $20

Adaptive Biotechnologies (NASDAQ:ADPT) has priced its IPO of 15M common shares at $20/share for gross proceeds of $300M.
Underwriters over-allotment is an additional 2.25M common shares.
Shares will begin trading on Nasdaq on June 27 under the ticker symbol “ADPT.”
Closing date is July 1.
Source: Press Release