Catalyst Biosciences Inc: This Analyst Even More Confident in Hemophilia B Asset Following Encouraging Phase II Data

FBR's George Zavoico looks ahead to CBIO's next pivotal trial, bullish on CB 269d's ability to lead to stable FIX activity into the mild hemophilia range.


Catalyst Biosciences Inc (NASDAQ:CBIO) is a biotech mover and shaker, ever since the drug maker unveiled successful Phase II data in its Hemophilia B Phase I/II study.

Investors liked what they heard on Friday’s 11th Annual Congress of the European Association for Haemophilia and Allied Disorders (EAHAD) in Madrid, Spain. In reaction to the positive clinical data read-out, the bulls roared as CBIO shares shot up almost 11% yesterday and continued to rise another 3% after hours.

Specifically, the biotech-verse has its eyes on compelling asset CB 2679d, a Factor IX (FIX) variant designed as a prophylactic subcutaneous (SQ) injection to treat severe Hemophilia B.

Should Catalyst eventually gain a green light, the company’s treatment could be the first to gain an FDA nod for this kind of injection in the Hemophilia B market.

Additionally, the company revealed yesterday plans to issue a public offering of common stock. These net proceeds could be used to bolster clinical as well as manufacturing activities for CB 2679d.

FBR analyst George Zavoico cheers CBIO’s clinical stride forward, reiterating a Buy rating on the stock with a $19 price target, which implies a close to 47% downside from current levels. (To watch Zavoico’s track record, click here)

“These results increase our confidence in the feasibility that SQ prophylactic administration of CB2679d/ISU304 can lead to stable FIX activity into the high end of the mild hemophilia range (5% to <40%) or into the normal range (40% or more) of FIX activity levels in patients with severe-to-moderate hemophilia B. Importantly, we believe administration of CB2679d/ISU304 will be able to be personalized to achieve a target FIX activity that will be determined by a patient and their physician. Catalyst Bio is planning a Phase IIb trial to explore various dosing strategies and longer duration dosing to determine an optimal dosing regimen for a pivotal Phase III trial. We are in the process of revising our model to account for the positive trial results and changes in the timeline to the start of the next and subsequent pivotal trial, BLA submission, and commercial launch,” highlights Zavoico.

Notably, the analyst wagers elevated FIX levels have good probability to be realized with longer dosing. Though FIX activity levels rose into the mild hemophilia range, the fact that levels continued to soar linearly past the sixth day indicates to Zavoico a key point: “higher FIX activity levels can be achieved and sustained with longer duration of dosing.” Accordingly, the analyst keeps his eyes peeled to the company’s forthcoming plans for a Phase IIB study to prove that this can be realized.

With regard to adverse events, the analyst bet on a well-tolerated drug candidate, noting he set expectations for few mild-to-moderate adverse events- events that wouldn’t generate inhibitory antibodies. CBIO’s Hemophilia B asset only saw one patient report mild pain, erythema, and redness at the injection site; and two patients experience bruising following the first injection. However, Zavoico concludes noting those events did not transpire amid dosing that followed, and no inhibitors were generated throughout the course of treatment, nor by the follow-up two weeks later.

TipRanks points to a largely bullish sentiment floating around the Street in the last year on CBIO’s opportunity at hand. All 3 analysts polled in the last 12 months rate a Buy on Catalyst Biosciences stock. With a healthy return potential of 26%, the stock’s consensus target price stands at $45.00.