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Coverage Initiated on Developer of Treatment for Myelofibrosis, GvHD, COVID-19
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A BTIG report noted that CTI Biopharma's Pacritinib "has the potential to be a lead therapeutic in the myelofibrosis space and in additional indications that could provide material value to CTI and CTI's shares over time."

In an August 9 research note, analyst Robert Hazlett reported that BTIG initiated coverage on CTI BioPharma (CTIC:NASDAQ), a developer of therapeutics for blood-related cancers, with a Buy rating and a $7 per share target price. In comparison, the current share price is about $2.80.

Hazlett discussed CTI BioPharma's lead therapeutic candidate Pacritinib and its potential as a therapeutic for various indications. Pacritinib is a late-stage JAK2 inhibitor that also possesses activity against the IRAK4, FLT3 and CSF1R kinases.

Pacritinib could be approved and used in patients who have myelofibrosis, a progressive bone marrow cancer, and thrombocytopenia (a low platelet count). It also has potential in acute graft versus host disease (GvHD), COVID-19 and other oncology indications and combinations.

In myelofibrosis, JAK-2 focused therapeutics are generally contraindicated as a treatment because they reduce patients' platelet counts, Hazlett relayed. Pacritinib, however, does not appear to have that effect. As such, Pacritinib could potentially fill an unmet need in myelofibrosis patients with severe thrombocytopenia (platelet count is below 50,000 per microliter) as no therapeutics exist for this population. CTI BioPharma is pursuing this avenue first.

Recently the U.S. Food and Drug Administration approved, with priority review, CTI's new drug application for Pacritinib to be used in myelofibrosis patients with severe thrombocytopenia. A tentative action date was set for Nov. 30, 2021. BTIG estimates that, if approved, CTI BioPharma could commercially launch Pacritinib in myelofibrosis in the U.S. in late 2021-early 2022, Hazlett noted.

Pacritinib also has potential as a treatment for myelofibrosis patients with less severe thrombocytopenia (those with a platelet count below 100,000 per microliter). These patients account for about two-thirds of the entire, roughly 20,000 myelofibrosis patient population in the States.

Three trials, the Phase 3 PERSIST-1, the Phase 3 PERSIST-2 and Phase 2 PAC203, have shown Pacritinib to be efficacious in treating myelofibrosis.

"We believe that Pacritinib has the potential to be a lead therapeutic in the myelofibrosis space and in additional indications that could provide material value to CTI and CTI's shares over time," wrote Hazlett.

A second indication in which CTI BioPharma is evaluating Pacritinib is GvHD, common in patients who undergo an allogenic hematopoietic stem cell transplant, Hazlett noted. About 9,000 of these transplants are done in the U.S. each year, according to CTI. About 40% of those transplant patients experience grade two to four GvHD, and another 40% suffer chronic GvHD, indicating an unmet need. Data from the Phase 2 study of Pacritinib in GvHD, now underway, are expected in H2/21.

CTI BioPharma is investigating Pacritinib in COVID-19 as well. Interim data (for 200 patients) from the in-progress Phase 3 PRE-VENT trial are due out in Q3/21.

"We consider the potential consideration of Pacritinib as a COVID-19 therapeutic as a high-risk, high-reward circumstance, largely representing upside to our estimates," Hazlett wrote.


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Disclosures from BTIG LLC, CTI Boipharma Corp, August 9, 2021

I, Robert "Bert" Hazlett, hereby certify that the views about the companies and securities discussed in this report are accurately expressed and that I have not received and will not receive direct or indirect compensation in exchange for expressing specific recommendations or views in this report.

BTIG LLC expects to receive or intends to seek compensation for investment banking services in the next 3 months from: CTI Biopharma Corp. (CTIC)

BTIG LLC had an investment banking services client relationship during the past 12 months with: CTI Biopharma Corp. (CTIC)

BTIG LLC managed or co-managed a public offering of securities in the past 12 months for: CTI Biopharma Corp. (CTIC)

BTIG LLC has received compensation for investment banking services in the past 12 months from: CTI Biopharma Corp. (CTIC)

The research analyst(s) responsible for the preparation of this report receives compensation based upon a variety of factors, including the quality and accuracy of research, internal/client feedback, and overall Firm revenues.

This research report is not an offer to buy or sell or solicitation of an offer to buy or sell any security in any jurisdiction where such an offer or solicitation would be illegal. This research report was not drafted specifically for any particular individual or entity and is not a personal recommendation to participate in any particular trading strategy or transaction. Any recipient of this research report should obtain independent advice specific to their personal circumstances before undertaking any investment activity and
must make their own independent evaluation of any securities or financial instruments.

Facts, views or opinions presented in this report have not been reviewed by, and may not reflect information known to, employees or other professionals in the “BTIG Group” (BTIG Group includes, but is not limited to, BTIG and its parents, subsidiaries and/or affiliates). BTIG Group employees, including Sales Representatives and Traders, may provide oral or written commentary or advice that may be inconsistent with the opinions and/or views expressed in this research report. BTIG Group employees and/or its affiliates not involved in the preparation of this research report may have investments in securities or derivatives of securities of companies mentioned in this report that are inconsistent with the views discussed in this report.


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