March 18, 2016
By Mark Terry, BioSpace.com Breaking News Staff
Palo Alto, Calif.-based Carbylan Therapeutics announced yesterday that it had hired Wedbush PacGrow to provide strategic advice.
Carbylan is a clinical-stage specialty drug company that is primarily focused on pain treatments related to osteoarthritis. It currently has a product candidate, Hydros-TA, which is an intra-articular, injectable compound for osteoarthritis of the knee.
“As we work to enhance value for our shareholders, we believe it is important to identify and evaluate all options available to us, and believe that Wedbush PacGrow is an ideal partner to advise us on this process,” said David Renzi, Carbylan’s president and chief executive officer, in a statement. “The Wedbush PacGrow team has many years of proven experience assisting companies in maximizing shareholder value and has been a strong supporter of Carbylan Therapeutics, including as an underwriter in our IPO in April 2015.”
On Feb. 1, Carbylan announced results from its Phase III trial of Hydros-TA. The primary endpoints were changes from baseline in the WOMAC A pain scores at week 2 for Hydros-TA versus Hydros and at week 26 for Hydros-TA versus triamcinolone acetonide. Safety was also assessed.
The study showed statistically significant improvement compared to the baseline in the week 2 Hydros studied. It also maintained significant pain reduction over 26 weeks. In other words, it met its first primary endpoint.
But, in the TA arm, patients continued to show significant reduction in pain through 26 weeks, which was unexpected. Therefore, the trial did not meet its second primary endpoint. The Hydros-TA was generally well tolerated with only mild knee pain and swelling.
“We are pleased to have achieved one of our primary endpoints in our COR1.1 trial,” Renzi said in a statement. “This demonstrates that Hydros-TA can provide early onset of pain relief with a low-dose corticosteroid. However, patients who received the corticosteroid triamcinolone acetonide, or TA, showed a prolonged pain-reduction through 26 weeks, which was unexpected based on clinical experience and published literature.”
The company plans to continue reviewing the trial data.
Carbylan hasn’t yet released its 2015 year-end financials. It released its third-quarter financials on Nov. 11, 2015, indicating it had $59.8 million in cash and cash equivalents, enough to continue operations for the next 12 months. Research and development expenses for the third quarter were $3.5 million, up from $2.1 million in the same period in 2014, primarily related to the Phase III program.
Carbylan stock at $9.04 on June 8, 2015 and has been on an pretty consistent slide ever since. Shares traded on Oct. 27 for $3.30, recovered to $4.71 on Nov. 5, then rolled downward to $2.43 on Jan. 29, 2016, then plunged to $0.66 on Feb. 2, which is also its current trading price.
On Feb. 2, Wedbush analysts gave it an “outperform” rating with a $14 price target. On the same day, analysts at Leerink Swann downgraded the company to “market perform” with a price target of $1.80.
The company has engaged Wedbush PacGrow to provide advice on a variety of actions, which could include an acquisition, merger, strategic partnership or other alternatives.
