On August 14, 2018 Onconova Therapeutics, Inc. (NASDAQ: ONTX), a Phase 3 stage biopharmaceutical company focused on developing rigosertib, a novel small molecule drug candidate to treat cancer, with a primary focus on Myelodysplastic Syndromes (MDS), reported financial results for the second quarter of 2018, ended June 30, 2018 (Press release, Onconova, AUG 14, 2018, View Source [SID1234528879]). The Company ended the second quarter with $29.5 million in cash and cash equivalents, which included proceeds from an underwritten public offering completed in this quarter.
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"We are pleased to have completed our public offering in May, which included new fundamental institutional biotech investors and broadened our shareholder base," commented Dr. Ramesh Kumar, Chief Executive Officer. "Combined with the financing we completed earlier this year and a licensing agreement in Latin America with Pint Pharma, we have significantly strengthened our balance sheet, providing a pathway to reaching anticipated key milestones in 2018 and 2019."
Steven M. Fruchtman, M.D., President, stated, "During the second quarter of 2018, we continued to make progress in our rigosertib clinical programs, including our IV rigosertib Phase 3 INSPIRE trial for 2nd-line higher-risk (HR) MDS patients. For this trial, we have opened new sites in countries already participating and added another country. We expect to complete the INSPIRE trial in the second half of 2019. After full enrollment of the Phase 2 oral rigosertib trial in combination with azacitidine in patients with either 1st-line HR-MDS or those with azacitidine-resistant disease, we are continuing to collect safety and efficacy data from this study. The combination trial with azacitidine is expected to advance to a pivotal Phase 3 trial for 1st-line HR-MDS patients in 2019, pending funding."
Upcoming Milestones (H2-2018 and 2019)
Top-line data for the pivotal Phase 3 INSPIRE study, which will be available after 288 death events. Total enrollment is expected to be 360 randomized patients
Presentation of updated efficacy and safety data from rigosertib/azacitidine combination Phase 2 studies in MDS at a medical meeting
Regulatory submissions for the Phase 3 trial in MDS of the combination program
Advance of RASopathy collaborative program to the clinic funded by NCI CRADA
Investigator initiated studies for rigosertib indications beyond MDS
IND for Dual CDK 4/6 + ARK5 inhibitor ON 123300 (IND studies funded by HanX Biopharmaceuticals)
Second Quarter Highlights
In June, Steven M. Fruchtman, M.D., Chief Medical Officer and Senior Vice President, Research and Development, was promoted to President. During his three and a half year tenure, Dr. Fruchtman has been instrumental in advancing rigosertib to key data milestones. In his new role, Dr. Fruchtman is now providing leadership across the Company’s entire product portfolio.
In May, Onconova strengthened its balance sheet with the successful completion of a $28.75 million upsized underwritten public offering. This financing, combined with the $10.0 million offering completed in February 2018, enables the Company to advance its late-stage programs in MDS to key upcoming milestones; the start of the combination therapy pivotal studies in MDS will require additional funding and/or business development transactions.
ON 123300, a first-in-class dual inhibitor of CDK4/6 + ARK5 has potential applications in a variety of cancers and is advancing toward clinical development in partnership with HanX Biopharmaceuticals, our Greater China collaborator. Following pre-IND consultations with the U.S. Food and Drug Administration, HanX has commenced manufacturing and toxicology studies to support filing of an IND in the U.S.
Second Quarter 2018 Financial Results
Cash and cash equivalents at June 30, 2018, totaled $29.5 million, compared to $4.0 million at December 31, 2017. This includes the net proceeds from the $28.75 million financing completed in May 2018, including the exercise in full of the underwriter’s over-allotment option.
Net loss was $4.3 million for the second quarter ended June 30, 2018, compared to a net loss of $2.6 million for the second quarter ended June 30, 2017, primarily due to a $3.5 million gain on the change in warrant liability in the 2017 period compared to $0.5 million gain in the 2018 period. Research and development expenses were $4.1 million for the second quarter ended June 30, 2018, and $4.6 million for the comparable period in 2017. General and administrative expenses were $2.1 million for the second quarter ended June 30, 2018, and $1.8 million for comparable period in 2017.
Net loss was $9.4 million for the six months ended June 30, 2018, compared to a net loss of $10.9 million for the six months ended June 30, 2017, primarily due to $0.8 million of license fee revenue and $0.9 million less research and development expenses in the 2018 period.
The Company will host a conference call on Tuesday, August 14, at 9:00 a.m. Eastern Time to provide a corporate update and discuss second quarter 2018 financial results. Interested parties may access the call by dialing toll-free (855) 428-5741 from the U.S., or (210) 229-8823 internationally, and using conference ID: 5287175. The call will also be webcast live. Please click here to access the webcast. A replay will be available at this link until November 30, 2018.