SEC Form 424B5 filed by Palvella Therapeutics Inc.
| | | |
Per share
|
| |
Total
|
| ||||||
| Public offering price | | | | $ | 125.00 | | | | | $ | 200,000,000 | | |
| Underwriting discounts and commissions(1) | | | | $ | 7.50 | | | | | $ | 12,000,000 | | |
| Proceeds to Palvella Therapeutics, Inc., before expenses | | | | $ | 117.50 | | | | | $ | 188,000,000 | | |
| |
TD Cowen
|
| | Cantor | | | Stifel | | | Mizuho | | |
LifeSci
Capital |
| |
Oppenheimer & Co.
|
| |
Canaccord
Genuity |
| |
H.C. Wainwright & Co.
|
|
| |
Lucid Capital Markets
|
| | Jones | | |
Clear Street
|
| | Craig-Hallum | |
| | | | | | S-ii | | | |
| | | | | | S-1 | | | |
| | | | | | S-5 | | | |
| | | | | | S-7 | | | |
| | | | | | S-10 | | | |
| | | | | | S-12 | | | |
| | | | | | S-13 | | | |
| | | | | | S-15 | | | |
| | | | | | S-16 | | | |
| | | | | | S-21 | | | |
| | | | | | S-29 | | | |
| | | | | | S-29 | | | |
| | | | | | S-29 | | | |
| | | | | | S-29 | | |
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|
Efficacy Endpoints at Week 24
(ITT Population, N=49) |
| |
Mean
Change |
| |
Two-sided
p-value |
| |||
|
Primary: Microcystic LM Investigator Global Assessment (mLM-IGA)*
|
| |
+2.13
|
| | | | p<0.001 | | |
|
Key Secondary: Blinded mLM Multi-Component Static Scale (mLM-MCSS)**
|
| |
-3.36
|
| | | | p<0.001 | | |
|
Secondary: Patient Global Impression of Change (PGI-C)*
|
| |
+1.9
|
| | | | p<0.001 | | |
|
Secondary: Live mLM-MCSS**
|
| |
-4.6
|
| | | | p<0.001 | | |
|
Secondary: Clinician Global Impression of Severity (CGI-S)***
|
| |
-1.7
|
| | | | p<0.001 | | |
|
Secondary: Patient Global Impression of Severity (PGI-S)***
|
| |
-1.0
|
| | | | p<0.001 | | |
us
| |
Public offering price per share
|
| | | | | | | | | $ | 125.00 | | |
| |
Historical net tangible book value per share as of September 30, 2025
|
| | | $ | 3.49 | | | | | | | | |
| |
Decrease in net tangible book value per share attributable to the pro forma adjustments described above
|
| | | $ | 0.35 | | | | | | | | |
| |
Pro forma net tangible book value per share as of September 30, 2025
|
| | | $ | 3.14 | | | | | | | | |
| |
Increase in pro forma net tangible book value per share attributable to this
offering |
| | | $ | 12.67 | | | | | | | | |
| |
Pro forma as adjusted net tangible book value per share after giving effect to this offering
|
| | | | | | | | | $ | 16.16 | | |
| |
Dilution per share to new investors participating in this offering
|
| | | | | | | | | $ | 108.84 | | |
|
Underwriter
|
| |
Number of
Shares |
| |||
|
TD Securities (USA) LLC
|
| | | | 432,000 | | |
|
Cantor Fitzgerald & Co.
|
| | | | 336,000 | | |
|
Stifel, Nicolaus & Company, Incorporated
|
| | | | 336,000 | | |
|
Mizuho Securities USA LLC
|
| | | | 120,000 | | |
|
LifeSci Capital LLC
|
| | | | 112,000 | | |
|
Oppenheimer & Co. Inc.
|
| | | | 81,600 | | |
|
Canaccord Genuity LLC
|
| | | | 64,000 | | |
|
H.C. Wainwright & Co., LLC
|
| | | | 64,000 | | |
|
Lucid Capital Markets, LLC
|
| | | | 16,000 | | |
|
JonesTrading Institutional Services LLC
|
| | | | 12,800 | | |
|
Clear Street LLC
|
| | | | 12,800 | | |
|
Craig-Hallum Capital Group LLC
|
| | | | 12,800 | | |
|
Total
|
| | | | 1,600,000 | | |
| | | |
Total
|
| |||||||||||||||
| | | |
Per Share
|
| |
Without
Option |
| |
With
Option |
| |||||||||
|
Public offering price
|
| | | $ | 125.00 | | | | | | 200,000,000 | | | | | | 230,000,000 | | |
|
Underwriting discounts and commissions
|
| | | $ | 7.50 | | | | | | 12,000,000 | | | | | | 13,800,000 | | |
|
Proceeds, before expenses, to us
|
| | | $ | 117.50 | | | | | | 188,000,000 | | | | | | 216,200,000 | | |
353 W. Lancaster Ave, Suite 200
Wayne, PA 19087
(484) 253-1461
Attention: Chief Financial Officer
Preferred Stock
Debt Securities
Warrants
Units
Rights
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353 W. Lancaster Ave, Suite 200
Wayne, PA 19087
(484) 253-1461
Attention: Chief Financial Officer
|
Efficacy Endpoints at Week 12 (ITT Population)
|
| |
Mean Change
from Baseline (n=15) |
| |
Nominal,
Two-sided p-value |
| ||||||
|
Dynamic Change Scales (7-point scales ranging from -3 to +3; positive values indicate improvements from baseline)
|
| | | | | | | | | | | | |
|
Overall Cutaneous VM Investigator Global Assessment (Overall cVM-IGA)
|
| | | | 1.5 | | | | | | <0.001 | | |
|
cVM-IGA Height/Engorgement
|
| | | | 1.3 | | | | | | <0.001 | | |
|
cVM-IGA Appearance (visualization/color of affected veins)
|
| | | | 1.5 | | | | | | <0.001 | | |
|
cVM-IGA Bleeding
|
| | | | 0.7 | | | | | | 0.045 | | |
|
Overall Patient Global Impression of Change (PGI-C)
|
| | | | 1.1 | | | | | | <0.001 | | |
|
Static Severity Scales (5-point scales ranging from 1 to 5; negative values indicate improvements from baseline)
|
| | | | | | | | | | | | |
|
Overall Clinician Global Impression of Severity (CGI-S)
|
| | | | -1.0 | | | | | | <0.001 | | |
|
cVM-MCSS (Cutaneous VM Multi-Component Static Scale) Severity of Height/Engorgement
|
| | | | -1.3 | | | | | | <0.001 | | |
|
cVM-MCSS Severity of Appearance (visualization/color of affected veins)
|
| | | | -1.1 | | | | | | <0.001 | | |
|
Overall Patient Global Impression of Severity (PGI-S)
|
| | | | -0.5 | | | | | | 0.027 | | |
| |
TD Cowen
|
| | Cantor | | | Stifel | | | Mizuho | | |
LifeSci
Capital |
| |
Oppenheimer & Co.
|
| |
Canaccord
Genuity |
| |
H.C. Wainwright & Co.
|
|
| |
Lucid Capital Markets
|
| | Jones | | |
Clear Street
|
| |
Craig-Hallum
|
|