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): January 12, 2015
DYAX
CORP.
(Exact
Name of Registrant as Specified in Charter)
Delaware
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000-24537
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04-3053198
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(State or Other Jurisdiction of
Incorporation)
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(Commission File Number)
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(IRS Employer Identification No.)
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55 Network Drive Burlington, MA 01803
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(Address
of Principal Executive Offices) (Zip Code)
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(617) 225-2500
(Registrant’s
telephone number, including area code)
Not
Applicable
(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:
⃞
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 7.01
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Regulation FD Disclosure.
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Beginning on January 12, 2015, Dyax Corp. (the “Company”) intends to
make available to investors a presentation regarding the Company’s
business, including its product and development portfolio and licensing
portfolio, strategy and outlook. A copy of the presentation is
furnished as Exhibit 99.1 to this Form 8-K.
Item 9.01.
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Financial Statements and Exhibits.
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(d)
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Exhibits.
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99.1
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Dyax Corp. January 2015 Corporate Presentation.
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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.
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DYAX CORP.
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Dated:
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January 12, 2015
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By:
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/s/ Gustav Christensen
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Gustav Christensen
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Chief Executive Officer and President
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EXHIBIT INDEX
Exhibit No.
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Description
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99.1
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Dyax Corp. January 2015 Corporate Presentation.
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Exhibit 99.1
1: January 2015 Corporate
Presentation SubTitle: January 12, 2015
2: Forward Looking
Statements Other Placeholder: 2 This presentation contains
forward-looking statements regarding Dyax’s business plans, strategies
and outlook. These statements may include, without limitation:
statements regarding the potential benefits and usage of KALBITOR®
(ecallantide) for treating HAE; the commercial potential of KALBITOR,
including revenues and costs; prospects for therapeutic benefits and
clinical development of DX-2930 and other potential product candidates
to address HAE and other plasma-kallikrein-mediated disorders; prospects
for future milestone payments and/or royalties with respect to licensee
product candidates in our Licensing and Funded Research Portfolio
(LFRP); the potential to enter into additional collaborative and
licensing arrangements for ecallantide and for other compounds in
development; the sufficiency of our cash, cash equivalents and
short-term investments; and expected future revenues, operating results
and cash flows.Statements that are not historical facts are based on our
current expectations, beliefs, assumptions, estimates, forecasts and
projections about the industry and markets in which Dyax competes. The
statements contained in this presentation are not guarantees of future
performance and involve certain risks, uncertainties and assumptions
that are difficult to predict. Therefore, actual outcomes and results
may differ materially from what is expressed in such forward-looking
statements. We caution investors not to place undue reliance on such
forward looking statements. There are many factors that could cause
actual results to differ materially from those in these forward-looking
statements. These factors include the following:• future sales levels of
KALBITOR and other commercial products and the profitability of such
sales, if any; • DX-2930 may not show sufficient therapeutic effect or
an acceptable safety profile in clinical trials for the treatment of HAE
or could take significantly longer time to gain regulatory approval than
Dyax expects or may never gain such approval;even if DX-2930 progresses
through clinical trials and gains regulatory approval, it may not gain
market acceptance;others may develop technologies or products superior
to DX-2930 or that reach the market before DX-2930;Dyax is dependent on
the expertise, effort, priorities and contractual obligations of third
parties in the manufacture, quality control, storage and clinical
development of KALBITOR and our pipeline products, including DX-2930;•
the amount and timing of milestone and royalty payments from our LFRP
collaborators and licensees related to their progress in developing and
commercializing products;• the costs of prosecuting, maintaining,
defending and enforcing our patents and other intellectual property
rights; • the overall condition of the financial markets; and • a
variety of other risks common to our industry. Additional factors that
could cause actual results to differ materially from those projected or
suggested in any forward-looking statements are contained in our recent
annual and quarterly reports filed with the Securities and Exchange
Commission, including those factors discussed under the caption "Risk
Factors" in such filings, which are incorporated in this presentation by
this reference. Forward-looking statements speak only as of the date of
this presentation, and we undertake no obligation to update or revise
them, except as may be required by law.
3: Dyax: An Evolving
Orphan Disease Company Other Placeholder: 3 Platform company HAE
company Kinin pathway company Orphan disease company Phage display
technology(Licensing & Funded Research Portfolio) DX-2930, preclinical
candidates Future pipeline candidates
4: Multiple Value Drivers
Other Placeholder: 4 KALBITOR® (ecallantide)DX-2930Future Pipeline
Candidates Approved ProductClinical Stage Product
CandidatesRoyalties/Milestones PRODUCT & DEVELOPMENT
PORTFOLIO LICENSING PORTFOLIO
5 : Dyax Product Strategy
6: Product and Development
Portfolio Other Placeholder: Current focus on plasma kallikrein-kinin
systemKALBITOR® (ecallantide) FDA approved product for the treatment of
acute attacks of hereditary angioedema (HAE) in patients 12 years of age
and olderPeptide inhibitor of plasma kallikreinDX-2930Clinical product
being developed for the prevention of HAE attacksFully human monoclonal
antibody inhibitor of plasma kallikrein Identifying other
plasma-kallikrein-mediated (PKM) disorders
7: HAE Disease Profile
Other Placeholder: 7 Rare, genetic disease characterized by
unpredictable episodes of severe, painful swelling1Attacks can affect
abdomen, face, larynx and/or extremities1 Patients suffer variable
number of attacks per yearThreat of mortality from laryngeal edema2Level
of depression similar to patients with severe asthma or Crohn’s
disease3 Zuraw BL. “Hereditary Angioedema.” The New England Journal of
Medicine 2008: 1027-1036.Bork K, Siedlecki K, Bosch S, Schopf R, Kreuz
W. “Asphyxiation by Laryngeal Edema in Patients With Hereditary
Angioedema.” Mayo Clin Proc. 2000: vol 75, 349-354.Lumry WR, Castaldo
AJ, Vernon MK, et al., “The humanistic burden of hereditary angioedema:
Impact on health-related quality of life, productivity, and depression.”
Allergy and Asthma Proceedings 10: 407-414.
8: KALBITOR®(ecallantide)
Other Placeholder: 8 Available in the U.S. to treat acute HAE attacks
in patients age 12+Approved for treating all attack locations including
hands, feet, face, abdomen, genitals and throatIn clinical trials,
KALBITOR improved attack symptoms at 4 hours and demonstrated sustained
efficacy through 24 hoursConsistent safety profile Requires
administration by a healthcare professional to manage potentially
serious hypersensitivity reactionsPatent protected through 2023
9: KALBITOR Business Other
Placeholder: KALBITOR business is profitable and cash flow positive3Q14
net sales were $20.3 million (nine months YTD = $49.4 million)Recent
revenue growth driven by:Treatment rateNew patientsPatient focused
market strategy: identifying and helping the right HAE patients receive
and stay on KALBITOR therapy Understanding patient needsComprehensive
patient engagement and support programsIndividualized patient approach
10: DX-2930 – Built by
Dyax Fully human monoclonal antibody for the potential prophylactic
treatment of HAETargets same pathway as KALBITORHigh affinity for
activated plasma kallikrein (Ki = 125 pM)Does not target
prekallikreinDoes not inhibit any other tested serine proteaseHigh
concentration formulation allows subcutaneous dosingLong half-life
allows infrequent administration
11: DX-2930 Phase 1b Study
in HAE Patients Other Placeholder: Ascending repeat dose study of
subcutaneous DX-2930 in HAE patients to assess safety, pharmacokinetics
and pharmacodynamicsRandomized, double-blind,
placebo-controlledEnrollment of 36 patients5 dose groups: 30 mg, 100
mg, 300 mg, 400 mg, 400 mg Patients randomized to active drug or placebo
in a 2:1 ratio15 week follow-up after the second dose for each
patientPlan to report complete Phase 1b data in early 2015
12: Summary of DX-2930
Phase 1a Study Other Placeholder: Pharmacokinetic (PK) profile suggests
feasibility of attaining stable target blood levelDose proportional
exposure Long half-life (approximately 17-21 days) following single
dose in healthy subjectsPharmacodynamic (PD) data consistent with
observed PK profileDose and time dependent inhibition of plasma
kallikreinBiomarker data suggests sustained bioactivity of several weeks
from single dose in healthy subjectsLow administration burdenSC
administration with low injection volumesNo injection site reactions in
healthy subjects after single dosePK data supports the potential for
infrequent dosing in HAE patientsSource: Dyax Phase 1a DX-2930 data
presentation; Feb. 25, 2014
13 Clinically relevant
target Plasma kallikrein is central to kinin pathway activationDX-2930
has high affinity for plasma kallikrein (Ki=125 pM) Safe for chronic
use Avoidance of off-target effects - no inhibition of any serine
protease testedPrekallikrein deficiency is asymptomatic Long half-life
and predictable pharmacokinetic (PK) profile Half life of 17 – 21 days
in normal individuals*Dose proportional PK profile* Convenient
administration SC route of administrationLow injection volumeInfrequent
dosing Title: Key Attributes of a Prophylactic Agent Other Placeholder:
13 * Source: Dyax Phase 1a DX-2930 data presentation; Feb. 25, 2014
14: PKM Disorders Beyond
HAE Other Placeholder: Determine if plasma kallikrein activation occurs
as part of other inflammatory disorders:Diabetic macular edemaUlcerative
colitis Crohn’s diseaseRheumatoid arthritisUsing a number of tools to
explore the plasma kallikrein pathway:Biomarker assaysLiteratureKey
Opinion LeadersCurrent focus on plasma kallikrein-kinin system
15: Licensing Portfolio
Other Placeholder: 15
16: Dyax Licensing
Portfolio Other Placeholder: Built around proprietary antibody discovery
technologyAddressing significant therapeutic marketsLicensing agreements
with top-tier companiesMultiple late-stage clinical programs Several
product development events projected in the next 12 months All antibody
product candidates have 2-3% royalties (net to Dyax) for 10 years
from first commercial saleDyax royalties commenced in mid-2014 with the
launch of Eli Lilly and Company’s CYRAMZA® (ramucirumab) Other
Placeholder: 16 The trademarks and registered trademarks shown herein
are the property of their respective owners.
17 Lilly Lilly CYRAMZA®
(ramucirumab ) (VEGFR-2/KDR)Gastric cancer (REGARD)Gastric cancer
(RAINBOW)NSCLC (REVEL)Hepatocellular cancer (REACH)Colorectal cancer
(RAISE)Necitumumab (IMC-11F8) (EGFR)NSCLC (SQUIRE)Trebananib+ (AMG 386)
(Ang-1/Ang-2)Ovarian cancer (TRINOVA-2 and -3)Ramucirumab – multiple
Phase 2 trialsNecitumumab – multiple Phase 2 trialsANTI-LINGO-1 (BIIB
033) (LINGO-1)Acute optic neuritis (RENEW)Multiple sclerosis
(SYNERGY)MM-121 (ErbB3)Breast CancerOvarian CancerMM-141 (Bispecific:
IGF-1R & ErbB3)AMG 780 (Ang-2)IMC-3C5 (VEGFR-3)Anti-MIF
(MIF)Undisclosed/not identified Merrimack Amgen Lilly Baxter Phase
3 Phase 2 Phase 1 Filing +Indicates milestone only Eli Lilly and
Company
(Lilly) Lilly Confidential Lilly Lilly Amgen Lilly Lilly Merrimack
Other Placeholder: 17 Compound/Indication Phase 1 Phase 2 Phase
3 Filing Approved Based on information publicly disclosed by
licensees for clinical stage and approved products; current as of Jan.
8, 2015 Approved Dyax Licensing Portfolio Merrimack Biogen
Idec Biogen Idec
18 Title: Financials and
Key Drivers
19: Financial Highlights
Financial guidance for 2015 will be presented in conjunction with the
release of 4Q and year-end 2014 financial results. Other Placeholder:
19 Source: Dyax 3Q14 press release issued on October 28, 2014
20: Near-Term Catalysts
*Based on information publicly disclosed by licensees; current as of
Jan. 8, 2015
21: IR Contact:Mary
jenkinsmjenkins@dyax.com617-250-5543 January 2015 Corporate Presentation
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