OREANDA-NEWS. Carbylan Therapeutics, Inc. (Nasdaq:CBYL) and KalVista Pharmaceuticals Ltd., a privately-held biopharmaceutical company, announced today that they, together with the shareholders of KalVista, have entered into a definitive share purchase agreement pursuant to which the shareholders of KalVista will become the majority owners of Carbylan.  If approved, Carbylan will be renamed KalVista Pharmaceuticals, Inc.

The transaction has been unanimously approved by the boards of directors of both companies.  Carbylan’s three largest shareholders, InterWest Partners, Alta Partners and Vivo Capital, who hold approximately 50% of Carbylan’s voting shares, have entered into agreements in support of the proposed transaction.  KalVista’s existing shareholders, which have unanimously agreed to the proposed transaction, include Longwood Fund, Novo A/S, RA Capital Management, SV Life Sciences and Venrock.  The transaction is subject to customary closing conditions, including approval by the stockholders of Carbylan. 

David Renzi, President and CEO of Carbylan stated:  "Following an extensive and thorough review of strategic alternatives, we concluded that the transaction with KalVista provides Carbylan stockholders a meaningful equity ownership stake and an attractive opportunity for value appreciation in a biopharmaceutical company with promising clinical assets and substantial upside potential.  We are optimistic that KalVista’s pipeline and strong leadership team, together with the combined company’s cash resources, will enable the company to reach significant milestones in KalVista’s pipeline."   

Andrew Crockett, KalVista’s CEO said:  “This transaction allows us to continue the development of our potentially best-in-class plasma kallikrein inhibitor platform, and rapidly advance our programs in HAE and DME, bringing much-needed treatments to patients.  We are in a very strong position to drive the growth of the combined company, and achieve the full potential of our therapeutic pipeline.”

Upon the closing of the transaction, the executive officers of KalVista will assume their respective positions at the combined company, and the executive officers of Carbylan will resign.  The Board of Directors of the combined company will include two members designated by Carbylan prior to the closing of the transaction.

KalVista shareholders will receive newly issued shares of common stock of Carbylan in connection with the transaction contemplated by the share purchase agreement.  Upon the closing of the transaction, existing KalVista equityholders are expected to own approximately 81% of the combined company, and existing Carbylan stockholders are expected to own approximately 19% of the combined company, each on a fully-diluted basis.  The percentage of the combined company that KalVista equityholders will own as of the closing of the transaction is subject to adjustment based on the amount of Carbylan’s net cash at closing date.  The share purchase agreement contains further details with respect to this adjustment and the transaction.

The proposed transaction is expected to close late in the third quarter or early in the fourth quarter of 2016.  The total cash balance, net of debt and expected transaction costs, of the combined company upon the closing of the proposed transaction is expected to be between $35 and $40 million, which is expected to be sufficient to allow the combined company to achieve meaningful clinical data.

Carbylan was advised in the proposed transaction by Wedbush PacGrow and KalVista was advised by Jefferies LLC.  Latham & Watkins LLP served as legal counsel to Carbylan and Fenwick & West LLP and Cooley LLP served as legal counsel to KalVista.

About KalVista
KalVista is a pharmaceutical company focused on the discovery, development, and commercialization of small molecule protease inhibitors for diseases with significant unmet needs.  KalVista has developed a proprietary portfolio of small molecule plasma kallikrein inhibitors targeting hereditary angioedema (HAE) and diabetic macular edema (DME).  The Company’s portfolio of orally delivered plasma kallikrein inhibitors for HAE is expected to commence Phase 1 clinical trials in the third quarter of 2016.  KalVista’s most advanced program, an intravitreally administered plasma kallikrein inhibitor for DME, has successfully completed Phase 1 clinical trials in DME patients and is being prepared for a Phase 2 clinical trial.

About Carbylan
Carbylan Therapeutics, Inc. is a clinical-stage specialty pharmaceutical company.  Carbylan’s initial focus was on the development of Hydros-TA, its proprietary, potentially best-in-class intra-articular injectable product candidate to treat pain associated with osteoarthritis of the knee.  Carbylan was incorporated in the state of Delaware on March 26, 2004 as Sentrx Surgical, Inc.  Carbylan’s name was changed to Carbylan Biosurgery, Inc. on December 14, 2005 and again to Carbylan Therapeutics, Inc. on March 7, 2014.

Since commencing operations in 2004, Carbylan has devoted substantially all of its efforts to identifying and developing product candidates for therapeutic markets, recruiting personnel and raising capital.  Carbylan has devoted predominantly all of its resources to the preclinical and clinical development of, and manufacturing capabilities for, Hydros-TA.

In February 2016, Carbylan announced topline results of COR1.1 trial, a Phase 3 clinical trial comparing treatment with Hydros-TA to treatment with Hydros and with TA, on a standalone basis.  Hydros-TA met the first of its two primary endpoints but did not meet its second primary endpoint. In April 2016, Carbylan announced that it had suspended further clinical development of Hydros-TA.