Full Press Release Details
June 24, 2016 / 12:00PM GMT, CBYL
Carbylan Therapeutics, Inc. and KalVista Pharmaceuticals Ltd. conference call to discuss the proposed transaction
CORPORATE PARTICIPANTS
David Renzi Carbylan Therapeutics, Inc. President and CEO
Andrew Crockett KalVista Pharmaceuticals Ltd. CEO
Greetings and welcome to the joint Carbylan/KalVista conference call.
At this time, all participants are in a listen only mode. A question and answer session will follow the formal presentation. If anyone should require
operator assistance during the conference, please press *0 on your telephone key pad. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Mr. David Renzi, President and Chief Executive
Officer of Carbylan Therapeutics. Thank you. You may begin.
David Renzi Carbylan Therapeutics, Inc. President and CEO
Good morning, everyone and thank you for joining us today to discuss the proposed transaction between Carbylan and KalVista. Joining me
today on the call is Andrew Crockett, Chief Executive Officer of KalVista.
Before we begin, I would like to remind everyone that any statements
made during this call other than the historical facts are forward-looking statements made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect
management s current expectations and are not guarantees of performance.
During the call, Carbylan and KalVista may make projections or other
forward-looking statements regarding, among other things, the timing and completion of the proposed transaction; expectations regarding capitalization, resources and ownership structure of the combined company; expectations regarding the sufficiency
of the combined company s resources to fund the advancement of any development program or the completion of any clinical trial; the nature, strategy and focus of the combined company; the safety, efficacy and projected development timeline and
commercial potential of any product candidates; and the executive officer and board structure of the combined company.
Actual results and the
timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, risks and uncertainties associated with Carbylan stockholder approval; the availability
of sufficient resources for operations and clinical development programs; the ability to successfully develop any of KalVista s product candidates; and the risks associated with the process of developing, obtaining regulatory approval for and
commercializing drug candidates that are safe and effective for use as human therapeutics.
Additionally, information regarding factors that could cause results to differ are described more fully in
Carbylan s periodic reports filed with the SEC.
I also note that in connection with the proposed transaction, Carbylan intends to file a proxy
statement and furnish or file other materials with the SEC. Carbylan shareholders are urged to read the proxy statement and those other materials when they become available because they will contain important information about the proposed
transaction and the parties to the transaction. The proxy statement and other relevant materials (when they become available) may be obtained free of charge at the SEC s website.
Carbylan, KalVista and each of our respective directors and executive officers may be deemed to be participants in the solicitation of proxies from the
shareholders of Carbylan in connection with the proposed transaction. Information regarding the interests of these directors and executives in the proposed transaction described herein will be included in the proxy statement I referred to a moment
ago. Additional information regarding the directors and executive officers of Carbylan is included in Carbylan s proxy statement for its 2016 Annual Meeting, which was filed with the SEC on April 28, 2016, and is supplemented by other
public filings made, and made with, the SEC by Carbylan.
Any comments made on this call shall not constitute an offer to sell or the solicitation
of an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification or applicable
exemption from the securities laws of any such jurisdiction.
Now, let s talk about the transaction and why we re extremely pleased with
this transformative event.
In a minute, I will turn the call over to Andrew Crockett, the Chief Executive Officer of KalVista, who will further
introduce and describe KalVista s platform, development programs and key value drivers, but let me first describe the background and the key terms of the transaction.
As you are all aware, since the outcome of the top-line results from our COR 1.1 Phase 3 clinical trial of Hydros-TA earlier this year, Carbylan s
board of directors and management team have been actively examining strategic alternatives to maximize shareholder value, including a potential acquisition, merger, strategic partnership or other strategic transaction. We undertook the review of our
strategic alternatives in consultation with our shareholders and in partnership with our financial advisor, Wedbush PacGrow.
this review, the team actively evaluated over 150 potential merger candidates and performed significant due diligence on a large number of these candidates over the last few months. Following this robust process, we ultimately concluded that the
proposed transaction with KalVista offered the opportunity to create the most significant value for Carbylan shareholders for several reasons, the main two being the attractive opportunity for value appreciation, and the meaningful equity ownership
stake provided to Carbylan shareholders in a biopharmaceutical company and with promising clinical assets and substantial upside potential.
KalVista is a pharmaceutical company focused on the discovery, development, and commercialization of small molecule protease inhibitors for diseases
with significant unmet needs. Since inception in 2011, the KalVista team has developed a proprietary portfolio of small molecule plasma kallikrein inhibitors targeting hereditary angioedema (HAE) and diabetic macular edema (DME).
KalVista is currently developing an oral plasma kallikrein inhibitor for the treatment of HAE, and has just
received approval to begin dosing a phase PK trial. KalVista s biologic and chemical insights on the target influence the way that we approach this historical problem of PK and oral plasma kallikrein inhibition in this field, and we believe
gives us a great chance of developing a best in class oral prophylaxis treatment for HAE.
Last week, we announced our entry into a definitive share
purchase agreement with KalVista and its shareholders, who include the Longwood Fund, Novo A/S, RA Capital Management, SV Life Sciences and Venrock. We are pleased that the respective board of directors of both Carbylan and KalVista have unanimously
approved the transaction.
Under the terms of the share purchase agreement, KalVista shareholders have agreed to sell their KalVista shares in
exchange for newly issued shares of Carbylan such that KalVista will become a wholly owned subsidiary of Carbylan and the shareholders of KalVista will become the majority owners of Carbylan. Upon the closing of the transaction, existing KalVista
equityholders are currently expected to own approximately 81% of the combined company, and existing Carbylan shareholders are currently expected to own approximately 19% of the combined company. The percentage of the combined company that will be
owned by Carbylan shareholders is subject to adjustment based on the amount of Carbylan s net cash at the closing of the transaction.
combined company will be named KalVista Pharmaceuticals and will be led by the KalVista management team. The board of directors of the combined company will include two members designated by Carbylan prior to the closing of the transaction.
The holders of a majority of the outstanding shares of Carbylan common stock must approve the transaction at a special meeting of shareholders that we
expect to occur late in the third quarter or early in the fourth quarter of 2016.
Subject to approval by a majority of Carbylan shareholders and
other customary closing conditions, we anticipate that we can close the transaction late in the third quarter or early in the fourth quarter of 2016. Carbylan s three largest shareholders, InterWest Partners, Alta Partners and Vivo Capital,
have entered into agreements in support of the transaction.
Before I turn the call over to Andrew, let me emphasize that the Carbylan board of
directors and management team believe that this transaction is in the best interests of Carbylan shareholders. We see the tremendous potential of KalVista and we believe that the transaction offers Carbylan shareholders a very compelling opportunity
for long-term value creation.
With that overview, I m delighted to turn the call over to Andrew Crockett, the Chief Executive Officer of
KalVista, for his comments on the transaction and KalVista s business and development programs. Andrew.
Andrew Crockett KalVista
Pharmaceuticals Ltd. CEO
Thanks very much, David. Good morning to everyone on the line and thank you for joining the call. I am very
excited about the transaction with Carbylan, and feel confident it provides an opportunity to build value for both companies shareholders with the ability to accelerate our lead programs in HAE and DME.
As David mentioned, KalVista is focused on the discovery, development, and commercialization of small
molecule protease inhibitors for diseases with significant unmet needs. We have developed a proprietary portfolio of plasma kallikrein inhibitors targeting HAE and DME.
KalVista s near term goal is to offer a best in class oral plasma kallikrein inhibitor for HAE. We believe that an oral drug administered daily for
the prophylactic treatment of HAE will be an important advancement in the treatment regimen of patients who suffer from this disease.
Angioedema, or HAE , is a rare genetic disease in which patients lack the ability to regulate plasma kallikrein activity. HAE patients suffer attacks of swelling which can occur in various parts of the body. While patients with HAE suffer
from debilitating and even life threatening attacks, these patients are usually otherwise healthy. Several lines of evidence have shown that plasma kallikrein is an important mediator of these attacks, and that inhibiting plasma kallikrein is able
to reduce both the frequency and severity of the attacks.
Our discovery platform continues to add to an existing portfolio containing multiple oral
plasma kallikrein inhibitors. KVD818 will be the first of those molecules to enter the clinic. I m happy to report that our clinical trial application for KVD818, our first oral plasma kallikrein inhibitor drug candidate, has been accepted by
the MHRA, the United Kingdom s regulatory authority, allowing us to begin our first-in-human trial. We anticipate enrolling our first subjects in the 3rd quarter of this year. This first in human study will provide data for the key
characteristics of safety, drug exposure and plasma kallikrein inhibition. We expect to report data from this study in the first half of next year.
We are currently progressing further candidates towards regulatory pre-clinical studies and plan to take at least one of those into the clinic in the
first half of next year. We believe taking multiple oral molecules into Phase 1 clinical trials gives us the most confidence and highest chance of success in achieving best in class oral status, and also enables us to pursue other indications where
plasma kallikrein inhibition currently shows promise.
The proposed transaction provides resources needed to achieve important clinical milestones
within the combined company. In addition, the newly combined company will be publically listed, maximizing our opportunity to leverage our small molecule plasma kallikrein inhibitor platform and ultimately take best in class molecules through to
NDA, and eventually to market.
Post transaction, KalVista is expected to have approximately $35-40 million dollars of net cash to advance our
pipeline. Our priority for use of these resources will be to advance our oral plasma kallikrein inhibitors into clinical trials for the treatment of HAE.
Since our founding in 2011, there have been two critical pillars that continue to drive KalVista s business today:
First, we have an experienced research team of scientists that have been working in the field of small molecule protease drug discovery for more than
two decades. This is a notoriously challenging drug discovery area and we believe that the experience of our team gives KalVista a significant competitive advantage. In addition, all of our molecules have been discovered by KalVista scientists.
These discoveries are the foundation of our intellectual property. This team continues to strengthen our plasma kallikrein platform and may enable KalVista to pursue additional protease drug targets beyond kallikrein in the future.
Second, our scientific co-founders from the Joslin Clinic at Harvard University are experts in the role of
plasma kallikrein in diseases with significant unmet need, our initial area of focus as a company.
The combination of drug discovery and plasma
kallikrein expertise, coupled with an experienced team that has been successful in bringing small molecule drugs to the market has yielded an exciting pipeline at KalVista.
While we are prioritizing our resources on development of our oral inhibitor platform for HAE, we are also advancing our intravitreal plasma kallikrein