First Wave BioPharma, Inc. is a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases. First Wave is currently advancing a therapeutic development pipeline populated with multiple clinical stage programs built around its two proprietary technologies – niclosamide, an oral small molecule with anti-viral and anti-inflammatory properties, and the biologic adrulipase, a recombinant lipase enzyme designed to enable the digestion of fats and other nutrients. First Wave’s niclosamide portfolio is led by three clinical programs: FW-COV, for COVID-19 gastrointestinal infections; FW-UP, for ulcerative proctitis (UP) and ulcerative proctosigmoiditis (UPS); and FW-ICI-AC, for Grade 1 and Grade 2 Immune Checkpoint Inhibitor-associated colitis (ICI-AC) and diarrhea in advanced oncology patients. Two additional formulations of niclosamide, FW-UC (for ulcerative colitis) and FW-CD (for Crohn’s disease) are expected to enter the clinic in 2022 and 2023, respectively. First Wave is also advancing FW-EPI (adrulipase) for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis and chronic pancreatitis. The Company is headquartered in Boca Raton, Florida with clinical operations in Hayward, California.
Company profile
Ticker
FWBI
Exchange
Website
CEO
James Sapirstein
Employees
Incorporated
Location
Fiscal year end
Industry (SIC)
Former names
AzurRx BioPharma, Inc., BioPharma d'Azur, Inc.
SEC CIK
Corporate docs
Subsidiaries
First Wave Bio, Inc. ...
FWBI stock data
Latest filings (excl ownership)
10-K
2022 FY
Annual report
20 Mar 23
8-K
First Wave BioPharma Announces $4.0 Million Private Placement Priced At-The-Market under Nasdaq Rules
15 Mar 23
8-K
Regulation FD Disclosure
7 Feb 23
8-K
First Wave BioPharma Announces Results of Special Meeting of Stockholders
17 Jan 23
DEFA14A
Additional proxy soliciting materials
9 Jan 23
8-K
Other Events
20 Dec 22
DEF 14A
Definitive proxy
16 Dec 22
8-K
Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard
16 Dec 22
EFFECT
Notice of effectiveness
9 Dec 22
424B3
Prospectus supplement
8 Dec 22
Transcripts
Latest ownership filings
Financial summary
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| Annual (USD) | Dec 22 | Dec 21 | Dec 20 | Dec 19 | |
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| Cash burn rate (est.) | Burn method: Change in cash | Burn method: Operating income | Burn method: FCF (opex + capex) | Last Q | Avg 4Q | Last Q | Avg 4Q | Last Q | Avg 4Q |
|---|---|---|---|---|---|---|
| Cash on hand (at last report) | 1.38 mm | 1.38 mm | 1.38 mm | 1.38 mm | 1.38 mm | 1.38 mm |
| Cash burn (monthly) | 98.03 k | 572.02 k | 759.89 k | 1.06 mm | 1.86 mm | 1.86 mm |
| Cash used (since last report) | 263.93 k | 1.54 mm | 2.05 mm | 2.84 mm | 5.02 mm | 5.01 mm |
| Cash remaining | 1.12 mm | -155.63 k | -661.43 k | -1.46 mm | -3.63 mm | -3.63 mm |
| Runway (months of cash) | 11.4 | -0.3 | -0.9 | -1.4 | -1.9 | -1.9 |
Institutional ownership, Q4 2021
39.5% owned by funds/institutions
| 13F holders | Current |
|---|---|
| Total holders | 1 |
| Opened positions | 0 |
| Closed positions | 1 |
| Increased positions | 0 |
| Reduced positions | 0 |
| 13F shares | Current |
|---|---|
| Total value | 2.08 mm |
| Total shares | 2.29 mm |
| Total puts | 0.00 |
| Total calls | 0.00 |
| Total put/call ratio | – |
| Largest owners | Shares | Value |
|---|---|---|
| Ross Edmund Burke Jr. | 2.29 mm | $2.08 mm |
Recent insider trades
| Date | Owner | Security | Transaction | Code | Indirect | 10b5-1 | $Price | #Shares | $Value | #Remaining |
|---|---|---|---|---|---|---|---|---|---|---|
| 3 Jan 23 | Riddell Alastair | Common Stock | Grant | Acquire A | No | No | 0 | 84,745 | 0.00 | 85,185 |
| 3 Jan 23 | Casamento Charles J | Common Stock | Grant | Acquire A | No | No | 0 | 84,745 | 0.00 | 85,134 |
| 3 Jan 23 | David Andrew Hoffman | Common Stock | Grant | Acquire A | No | No | 0 | 84,745 | 0.00 | 90,778 |
| 3 Jan 23 | Borkowski Edward | Common Stock | Grant | Acquire A | No | No | 0 | 84,745 | 0.00 | 86,156 |
| 3 Jan 23 | Sapirstein James | Common Stock | Grant | Acquire A | No | No | 0 | 300,000 | 0.00 | 300,000 |
News
Stocks That Hit 52-Week Lows On Tuesday
14 Mar 23
First Wave BioPharma Announces $4M Private Placement At $3.91/Shares And Accompanying Warrant
13 Mar 23
First Wave BioPharma Announced Second Patient Dosed in Phase 2 SPAN Clinical Trial of Enhanced Adrulipase Formulation in Cystic Fibrosis
10 Mar 23
HC Wainwright & Co. Reiterates Buy on First Wave BioPharma, Maintains $18 Price Target
9 Mar 23
12 Health Care Stocks Moving In Thursday's Pre-Market Session
9 Mar 23
Press releases
HOOKIPA Pharma Appoints Terry Coelho to its Board of Directors
13 Mar 23
First Wave BioPharma Announces Second Patient Dosed in Phase 2 SPAN Clinical Trial of Enhanced Adrulipase Formulation in Cystic Fibrosis
10 Mar 23
First Wave BioPharma Announces First Patient Dosed in Phase 2 SPAN Clinical Trial of Enhanced Adrulipase Formulation
9 Mar 23
First Wave BioPharma Announces First Patient Screened for Phase 2 SPAN Adrulipase Trial in Cystic Fibrosis
2 Feb 23
First Wave BioPharma to Present at the BIO CEO & Investor Conference
30 Jan 23