On August 8, 2019 Oncternal Therapeutics, Inc., (Nasdaq: ONCT) a clinical-stage biotechnology company developing potential first-in-class product candidates for cancers with critical unmet medical needs, reported financial results for the second quarter, which ended June 30, 2019, and provided a business update (Press release, Oncternal Therapeutics, AUG 8, 2019, View Source [SID1234538501]).
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"Oncternal is thrilled to provide its first quarterly results as a Nasdaq-listed Company. We are making great progress developing our clinical and preclinical programs as we head into the second half of 2019," said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO. "We are very encouraged by initial results from our lead clinical program’s Phase 1/2 study of cirmtuzumab in combination with ibrutinib in patients with chronic lymphocytic leukemia, and excited to be opening the randomized Phase 2 portion of the study. The early results for cirmtuzumab in combination with ibrutinib in patients with mantle cell lymphoma are also encouraging, and we expect to report data in this patient population before the end of the year. With respect to our other pipeline programs, our clinical study of TK216 in combination with vincristine in patients with Ewing sarcoma is advancing as planned, and we expect to begin enrolling patients in an expansion cohort of this study soon. Finally, we anticipate selecting a construct for IND-enabling studies of our ROR1 CAR-T program before the end of this year."
Recent Corporate Highlights
In August 2019, Oncternal announced it has opened for enrollment its randomized Phase 2 study of cirmtuzumab, a ROR1-targeted monoclonal antibody, combined with ibrutinib in patients with chronic lymphocytic leukemia (CLL). The decision to open the Phase 2 portion of the Company’s ongoing Phase 1/2 CIRLL (Cirmtuzumab and Ibrutinib targeting ROR1 for Leukemia and Lymphoma) clinical trial was triggered by favorable outcomes from the Part 1 dose-finding and Part 2 dose-confirming cohorts of the clinical trial, including the recently announced interim objective response rate (ORR) of 100% for the first nine CLL patients with evaluable data receiving the recommended dosing regimen who have completed 12 weeks of cirmtuzumab plus ibrutinib treatment in Part 2. The Company continues to see a well-tolerated safety profile consistent with that seen with ibrutinib treatment alone.
In June 2019, Oncternal announced that the reverse merger between GTx, Inc., GTx’s merger subsidiary and privately-held Oncternal Therapeutics, Inc., had closed and the combined company was renamed Oncternal Therapeutics, Inc. Trading on the Nasdaq stock exchange under the ticker symbol "ONCT" began on June 10, 2019. The closing of the merger was a transformative event that the Company believes will allow it to pursue its next level of corporate growth and continue to advance its oncology drug candidates in multiple cancer indications.
In June 2019, Oncternal presented interim data from its ongoing Phase 1/2 study of cirmtuzumab in combination with ibrutinib at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting – the largest oncology conference of the year. Results from the first 12 patients with CLL treated in the Part 1 dose-finding portion of the Phase 1 study showed an interim ORR of 91.7% for the combination of cirmtuzumab plus ibrutinib, including three patients with clinical or confirmed complete responses, and a well-tolerated safety profile consistent with that seen for ibrutinib treatment alone.
Oncternal also disclosed at the ASCO (Free ASCO Whitepaper) meeting that six patients with mantle cell lymphoma (MCL), had been treated in a separate cohort of the CIRLL study. One patient with MCL who had relapsed following an allogeneic stem cell transplant experienced a confirmed complete response (CR) after 3 months of cirmtuzumab plus ibrutinib treatment, including complete resolution of a large mediastinal mass. This CR appears to be durable, and has been confirmed after 6, 9 and 11 months of cirmtuzumab plus ibrutinib treatment.
Expected Upcoming Milestones
Cirmtuzumab Program
Oncternal anticipates reporting additional data from its Phase 1/2 study of cirmtuzumab in combination with ibrutinib from patients with CLL at a scientific conference in the fourth quarter of 2019
Oncternal anticipates reporting additional data from its Phase 1/2 study of cirmtuzumab in combination with ibrutinib from patients with MCL at a scientific conference in the fourth quarter of 2019
Oncternal anticipates reporting data from its Phase 1 study of cirmtuzumab in combination with paclitaxel from patients with breast cancer at a scientific conference in the fourth quarter of 2019
TK216 Program
Oncternal anticipates completing the dose finding portion of its Phase 1 study of TK216 for patients with Ewing sarcoma and opening the expansion cohort in the third quarter of 2019
Oncternal anticipates reporting data from its Phase 1 study of TK216 from patients with Ewing sarcoma at a scientific conference in the fourth quarter of 2019
ROR1 CAR-T Program
Oncternal anticipates selecting a candidate CAR-T construct for IND-enabling studies in hematologic cancers in the second half of 2019, and opening clinical trials for hematological cancers in 2020
Oncternal anticipates selecting a candidate CAR-T construct for IND-enabling studies in solid tumors in 2020
Financial Results
On June 7, 2019, the former privately-held Oncternal Therapeutics, Inc. ("Private Oncternal"), completed a reverse merger transaction with GTx, Inc. and its merger subsidiary. Under the merger agreement, a wholly-owned subsidiary of GTx, Inc. merged with and into Private Oncternal, with Private Oncternal surviving as a wholly-owned subsidiary of the merged parent company. The surviving parent entity changed its corporate name from GTx, Inc. to Oncternal Therapeutics, Inc., and commenced trading on the Nasdaq stock exchange under the ticker symbol "ONCT."
The transaction was accounted for as a reverse asset acquisition in accordance with generally accepted accounting principles. Under this method of accounting, Private Oncternal was deemed to be the accounting acquirer for financial reporting purposes. As a result, effective as of the closing date of the merger, the reported historical operating results prior to the merger closing date will be those of Private Oncternal. Information regarding the reverse merger transaction and our financial results is also included on form 10-Q to be filed with the SEC.
Grant revenue was $0.7 million for the quarter ended June 30, 2019. Our grant revenue is derived from a California Institute for Regenerative Medicine (CIRM) grant subaward with the University of California, San Diego. The grant was awarded to advance our lead program in a Phase 1/2 clinical trial evaluating cirmtuzumab in combination with ibrutinib for the treatment of patients with B-cell lymphoid malignancies CLL and MCL.
Total operating expenses for the second quarter ended June 30, 2019 were $22.3 million, which included in-process research and development expenses of $18.1 million that was recorded in connection with the closing of our merger transaction in June 2019.
Research and development expenses for the quarter totaled $2.6 million.
General and administrative expenses for the quarter totaled $1.6 million.
Including the one-time merger charge, net loss for the second quarter was $22.8 million, or a loss of $3.38 per share, basic and diluted.
As of June 30, 2019, Oncternal has $28.5 million in cash and cash equivalents. The Company believes these funds will be sufficient to fund its operations into the second quarter of 2020. As of June 30, 2019, we had 15.4 million shares of common stock outstanding.
Oncternal Management Hosting Conference Call and Live Webcast
Oncternal will host a conference call today, August 8, 2019, at 2:00 p.m. PDT (5:00 p.m. EDT) to review quarterly results and provide an update on clinical and preclinical development programs. A live webcast of the call will be available online and may be accessed from the "Investors" page of the company website at View Source A replay of the webcast will be available beginning approximately one hour after the conclusion of the call and will remain available for at least 30 days thereafter.