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Oncternal (ONCT) Down on Restructuring Plan to Extend Runway
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Shares of clinical-stage biopharmaceutical company Oncternal Therapeutics, Inc. (ONCT - Free Report) plunged 59.3% in aftermarket trading on Apr 3 after the company announced a strategic reorganization to extend its cash runway.
The reprioritization was undertaken on account of the rapidly changing commercial landscape for Bruton’s tyrosine kinase inhibitors (BTK inhibitors). Consequently, the company shelved the phase III and phase I/II study of zilovertamab in combination with Imbruvica.
This includes closing two studies of zilovertamab in combination with Imbruvica, the ongoing phase I/II study CIRM-0001 and the phase III study ZILO-301, a global registrational study in patients with relapsed/refractory mantle cell lymphoma (MCL). In addition, the company is looking for partnerships and collaborations for executing future late-stage clinical trials of zilovertamab.
Other projects and indirect expenses will also be reduced, which is estimated to extend the expected cash runway into 2025. The projected cash runway will support the advancement of two pipeline candidates, ONCT-808 and ONCT-534.
ONCT-808 is being evaluated for patients with resistant aggressive lymphoma, and ONCT-534 is being evaluated in patients with prostate cancer resistant to standard-of-care androgen receptor inhibitors. A phase I/II study has been initiated on ONCT-808 to treat patients with relapsed or refractory aggressive B-cell lymphoma, including those who have failed previous CD19 CAR T therapy. Preclinical models show robust and specific activity against ROR1-expressing cells from multiple tumor types. Initial data is expected in 2023.
Oncternal expects to submit an investigational new drug application (IND) for ONCT-534, its novel dual-action androgen receptor inhibitor (DAARI) in mid-2023. It has conducted IND-enabling studies on ONCT-534. A phase I/II study in patients with metastatic castrate-resistant prostate cancer (mCRPC) resistant to AR inhibitor treatment is expected to open shortly thereafter.
Management estimates that its cash, cash equivalents and short-term investments balance was $54.3 million at the end of the first quarter. It had 58.7 million shares of common stock outstanding as of Mar 31, 2023 and expects the cash balance to support planned operations into 2025.
Shares of Oncternal have fallen 21.0% in the year so far compared with the industry’s decline of 2.5%.
Image Source: Zacks Investment Research
Investors were most likely disappointed with the closing of the zilovertamab development program, as it was its most advanced candidate.
The successful development of the other two candidates remains the key for the company and the resources needed to fund these programs. Both candidates are still in the early stages of development.
Some BTK inhibitors approved for MCL are – Imbruvica, Calquence (acalabrutinib), and Brukinsa (zanubrutinib). Imbruvica was initially approved by the FDA in 2013 and is marketed by AbbVie and Johnson & Johnson. AstraZeneca’s (AZN - Free Report) Calquence was approved by the FDA in 2017. Brukinsa was initially FDA-approved in 2019 and is marketed by BeiGene.
AstraZeneca is currently evaluating Calquence in more than 20 company-sponsored clinical trials. Calquence is being evaluated for treating multiple B-cell blood cancers, including CLL, MCL, diffuse large B-cell lymphoma, Waldenström’s macroglobulinemia, marginal zone lymphoma and other hematologic malignancies.
In the past 30 days, estimates for Novo Nordisk’s 2023 earnings per share have risen from $4.20 to $4.43 and estimates for 2024 have gone up by 29 cents to $5.19.
Ligand’s earnings per share estimates for 2023 increased to $4.32 from $3.30 in the past 30 days. LGND beat earnings estimates in one of the last four reported quarters and missed the remaining three.
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Oncternal (ONCT) Down on Restructuring Plan to Extend Runway
Shares of clinical-stage biopharmaceutical company Oncternal Therapeutics, Inc. (ONCT - Free Report) plunged 59.3% in aftermarket trading on Apr 3 after the company announced a strategic reorganization to extend its cash runway.
The reprioritization was undertaken on account of the rapidly changing commercial landscape for Bruton’s tyrosine kinase inhibitors (BTK inhibitors). Consequently, the company shelved the phase III and phase I/II study of zilovertamab in combination with Imbruvica.
This includes closing two studies of zilovertamab in combination with Imbruvica, the ongoing phase I/II study CIRM-0001 and the phase III study ZILO-301, a global registrational study in patients with relapsed/refractory mantle cell lymphoma (MCL). In addition, the company is looking for partnerships and collaborations for executing future late-stage clinical trials of zilovertamab.
Other projects and indirect expenses will also be reduced, which is estimated to extend the expected cash runway into 2025. The projected cash runway will support the advancement of two pipeline candidates, ONCT-808 and ONCT-534.
ONCT-808 is being evaluated for patients with resistant aggressive lymphoma, and ONCT-534 is being evaluated in patients with prostate cancer resistant to standard-of-care androgen receptor inhibitors. A phase I/II study has been initiated on ONCT-808 to treat patients with relapsed or refractory aggressive B-cell lymphoma, including those who have failed previous CD19 CAR T therapy. Preclinical models show robust and specific activity against ROR1-expressing cells from multiple tumor types. Initial data is expected in 2023.
Oncternal expects to submit an investigational new drug application (IND) for ONCT-534, its novel dual-action androgen receptor inhibitor (DAARI) in mid-2023. It has conducted IND-enabling studies on ONCT-534. A phase I/II study in patients with metastatic castrate-resistant prostate cancer (mCRPC) resistant to AR inhibitor treatment is expected to open shortly thereafter.
Management estimates that its cash, cash equivalents and short-term investments balance was $54.3 million at the end of the first quarter. It had 58.7 million shares of common stock outstanding as of Mar 31, 2023 and expects the cash balance to support planned operations into 2025.
Shares of Oncternal have fallen 21.0% in the year so far compared with the industry’s decline of 2.5%.
Image Source: Zacks Investment Research
Investors were most likely disappointed with the closing of the zilovertamab development program, as it was its most advanced candidate.
The successful development of the other two candidates remains the key for the company and the resources needed to fund these programs. Both candidates are still in the early stages of development.
Some BTK inhibitors approved for MCL are – Imbruvica, Calquence (acalabrutinib), and Brukinsa (zanubrutinib). Imbruvica was initially approved by the FDA in 2013 and is marketed by AbbVie and Johnson & Johnson. AstraZeneca’s (AZN - Free Report) Calquence was approved by the FDA in 2017. Brukinsa was initially FDA-approved in 2019 and is marketed by BeiGene.
AstraZeneca is currently evaluating Calquence in more than 20 company-sponsored clinical trials. Calquence is being evaluated for treating multiple B-cell blood cancers, including CLL, MCL, diffuse large B-cell lymphoma, Waldenström’s macroglobulinemia, marginal zone lymphoma and other hematologic malignancies.
Oncternal currently carries a Zacks Rank #3 (Hold). Some well-placed stocks in the overall healthcare sector are Novo Nordisk (NVO - Free Report) and Ligand Therapeutics (LGND - Free Report) . Both carry a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, estimates for Novo Nordisk’s 2023 earnings per share have risen from $4.20 to $4.43 and estimates for 2024 have gone up by 29 cents to $5.19.
Ligand’s earnings per share estimates for 2023 increased to $4.32 from $3.30 in the past 30 days. LGND beat earnings estimates in one of the last four reported quarters and missed the remaining three.