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Form 424B3 Kadmon Holdings, Inc.

November 21, 2016 9:07 AM EST



 

Prospectus Supplement No. 3
(to Prospectus dated July 26, 2016)

Filed Pursuant to Rule 424(b)(3)
Registration No. 333-211949



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OFFERING PROSPECTUS

2,083,336 Shares of Common Stock



This prospectus supplement updates and supplements the prospectus dated July 26, 2016 (the “Prospectus”), which forms a part of our Registration Statement on Form S-1 (Registration No. 333-211949) (the “Registration Statement”). This prospectus supplement is being filed to update and supplement the information in the Prospectus, with the information contained in our Current Report on Form 8-K, filed with the Securities and Exchange Commission (the “Commission”) on November 21, 2016 (the “Current Report”). Accordingly, we have attached the Current Report to this prospectus supplement.

This prospectus supplement relates to the offer and sale of 2,083,336 shares of our common stock, par value $0.001 per share, by the existing holders of the securities named in the Prospectus.

This prospectus supplement should be read in conjunction with the Prospectus, which is to be delivered with this prospectus supplement. This prospectus supplement updates and supplements the information in the Prospectus. If there is any inconsistency between the information in the Prospectus and this prospectus supplement, you should rely on the information in this prospectus supplement.

Our common stock is quoted on the New York Stock Exchange under the trading symbol “KDMN.” On November 15, 2016, the last reported sale price of our common stock was $6.37 per share.



Investing in our securities involves a high degree of risk. You should review carefully the risks and uncertainties described under the heading “Risk Factors” beginning on page 10 of the Prospectus and beginning on page 53 of the Quarterly Report on Form 10-Q filed with the Commission on November 9, 2016, and under similar headings in any further amendments or supplements to the Prospectus before you decide whether to invest in our securities.



Neither the Commission nor any state securities commission has approved or disapproved of these securities or determined if the Prospectus or this prospectus supplement is truthful or complete. Any representation to the contrary is a criminal offense.



The date of this prospectus supplement is November 21, 2016.




 



UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported):  November 19, 2016

 

 

Kadmon Holdings, Inc.

(Exact name of registrant as specified in its charter)

 

 

 



 

 

 

 

 

 

 

 

 

Delaware

 

001-37841

 

27-3576929

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(I.R.S. Employer

Identification No.)

 

 

450 East 29th Street

New  York, NY

 

10016

(Address of principal executive offices)

 

(Zip Code)

Registrant’s telephone number, including area code (212) 308-6000

N/A

(Former name or former address, if changed since last report)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 



 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))


 

 

ITEM 8.01

Other Events.

On November 19, 2016, Kadmon Holdings, Inc. (the “Company”) issued a press release announcing additional data from its ongoing Phase 2a clinical study demonstrating the safety of tesevatinib, the Company’s oral tyrosine kinase inhibitor, for the treatment of autosomal dominant polycystic kidney disease. The data will be presented in a poster session on Saturday, November 19, 2016 at the American Society of Nephrology Kidney Week 2016 in Chicago, IL. The full text of the press release is attached to this Current Report on Form 8-K as Exhibit 99.1.





 

ITEM 9.01

Financial Statements and Exhibits.

(d) Exhibits.

 



 

Exhibit No.

Description



 

99.1

Press Release, dated November 19, 2016, issued by Kadmon Holdings, Inc.










 



SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 



 

 

 

 

 

 

 

 

 

 

 

 

 

Kadmon Holdings, Inc.

 

 

 

Date: November 21, 2016

 

 

 

/s/ Konstantin Poukalov

 

 

 

 

Konstantin Poukalov

 

 

 

 

Executive Vice President, Chief Financial Officer




 

Exhibit 99.1



Kadmon logo - blue - 5 26 15



Kadmon to Present Additional Data Demonstrating Tesevatinib Safety for the Treatment of Polycystic Kidney Disease at ASN Kidney Week 2016 

-- Data Support Tesevatinib Safety While Highlighting the Need for Innovative Methods to Measure Renal Function in Clinical Trials --

NEW YORK, November 19, 2016 – Kadmon Holdings, Inc. (NYSE: KDMN) (“Kadmon” or the “Company”) today announced additional data from its ongoing Phase 2a clinical study demonstrating the safety of tesevatinib, the Company’s oral tyrosine kinase inhibitor, for the treatment of autosomal dominant polycystic kidney disease (ADPKD). The data will be presented in a poster session on Saturday, November 19 at the American Society of Nephrology (ASN) Kidney Week 2016 in Chicago, IL.  

Recent findings from Kadmon’s ongoing Phase 2a study in patients with ADPKD have demonstrated that tesevatinib is well tolerated and have also identified tesevatinib 50 mg once daily (QD) as the optimal dose to treat ADPKD.

New data reported in the poster indicate that tesevatinib is a new member of a group of drugs known as MATE 1/2-K transporter inhibitors, such as cimetidine, which mildly increase levels of serum creatinine. Normally, an increase in serum creatinine can be used to indicate kidney damage, but in the case of MATE 1/2-K inhibitors, these serum creatinine increases occur without clinically meaningful alterations in renal function. 

Specifically, new data demonstrated that serum creatinine levels in tesevatinib patients increased by 10% to 14% during the first 28 days of treatment and reversed upon treatment discontinuation. Importantly, levels of cystatin C, another measure of renal function, were relatively unchanged during the same period. In vitro studies further demonstrated that tesevatinib potently inhibits MATE1/2-K transporters at tesevatinib concentrations achieved with the 50 mg QD dose. Therefore, MATE inhibition by tesevatinib may explain mild serum creatinine increases associated with tesevatinib treatment.  

“Kadmon has identified a contradiction in PKD drug development: MATE transporters such as tesevatinib increase levels of creatinine, the standard measure of PKD drug efficacy, but without clinically relevant effects on kidney function,” said James Tonra, Ph.D., Senior Vice President, Nonclinical Development at Kadmon and first author of the poster.  “These findings further characterize the safety of tesevatinib while highlighting the need for alternative methods to evaluate kidney function in PKD drug development.” 

“We believe these findings support the continued development of tesevatinib for PKD,” said John Ryan, M.D., Ph.D., Executive Vice President and Chief Medical Officer at Kadmon.  “Kadmon has had discussions with the FDA to develop innovative methods to demonstrate drug safety and efficacy in PKD, a major unmet medical need. These discussions will have important implications for clinical trial designs for tesevatinib as well as other therapies in development for renal diseases, especially MATE inhibitors.”


 

Kadmon continues to expand its work on tesevatinib at 50 mg QD in its ongoing Phase 2a study to evaluate the drug’s safety in patients with larger kidneys, indicative of more severely compromised renal function.  Data from the first six patients in this cohort are also discussed in the ASN Kidney Week poster.  In 2017, Kadmon plans to initiate a placebo-controlled study of tesevatinib in ADPKD as well as to initiate a dose-finding study in the pediatric form of the disease, autosomal recessive PKD. 

About Kadmon Holdings, Inc.

Kadmon Holdings, Inc. is a fully integrated biopharmaceutical company focused on developing innovative products for significant unmet medical needs.  We have a diversified product pipeline in autoimmune and fibrotic diseases, oncology and genetic diseases.  

Safe Harbor Statement

This press release contains forward-looking statements. Such statements may be preceded by the words “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “could,” “intends,” “targets,” “projects,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these terms or other similar expressions. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. We believe that these factors include, but are not limited to, (i) the initiation, timing, progress and results of our preclinical studies and clinical trials, and our research and development programs; (ii) our ability to advance product candidates into, and successfully complete, clinical trials; (iii) our reliance on the success of our product candidates; (iv) the timing or likelihood of regulatory filings and approvals; (v) our ability to expand our sales and marketing capabilities; (vi) the commercialization of our product candidates, if approved; (vii)  the pricing and reimbursement of our product candidates, if approved; (viii) the implementation of our business model, strategic plans for our business, product candidates and technology; (ix) the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technology; (x) our ability to operate our business without infringing the intellectual property rights and proprietary technology of third parties; (xi) costs associated with defending intellectual property infringement, product liability and other claims; (xii) regulatory developments in the United States, Europe and other jurisdictions; (xiii) estimates of our expenses, future revenues, capital requirements and our needs for additional financing; (xiv) the potential benefits of strategic collaboration agreements and our ability to enter into strategic arrangements; (xv) our ability to maintain and establish collaborations or obtain additional grant funding; (xvi) the rate and degree of market acceptance of our product candidates; (xvii) developments relating to our competitors and our industry, including competing therapies; (xviii) our ability to effectively manage our anticipated growth; (xix) our ability to attract and retain qualified employees and key personnel; and (xx) our ability to achieve cost savings and other benefits from our efforts to streamline our operations and to not harm our business with such efforts. More detailed information about Kadmon and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the U.S. Securities and Exchange Commission (SEC), including the Company's Quarterly Report on Form 10-Q filed pursuant to Section 13 of the Securities Exchange Act of 1934, as amended, with the SEC on November 9, 2016. Investors and security holders are urged to read these documents free of


 

charge on the SEC's web site at www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

Contact Information



Ellen Tremaine, Investor Relations

646.490.2989

[email protected]



Maeve Conneighton, Media

212.600.1902

[email protected]

 

 






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