SeeThruEquity Initiates Coverage on Onconova Therapeutics, Inc. (NASDAQ: ONTX) with a Price Target of $5.00

NEW YORK, NY / ACCESSWIRE / January 12, 2017 / SeeThruEquity, the leading independent equity research firm focused on smallcap and microcap public companies, today announced it has initiated coverage on Onconova Therapeutics, Inc. (ONTX) with a 12 month price target of $5.00.

The report is available here: ONTX Initiation Report.

We initiate coverage on Onconova Therapeutics, Inc. (NASDAQ: ONTX, "Onconova") with a price target of $5.00. Onconova is a Phase 3 clinical-stage biopharmaceutical company focused on developing novel therapeutics to treat cancer. With headquarters in Newtown, PA, Onconova was founded in 1998 and became a public company through an initial public offering on the NASDAQ in 2013. Onconova is initially focused on developing therapeutics for cancer patients with unmet needs. The company employs a proprietary chemistry that seeks to target specific RAS cellular pathways, which have been linked to cancer cells, while causing minimal damage to healthy cells. Its lead candidate, rigosertib, is in advanced clinical trials investigating its use as treatment for myelodysplastic syndromes (MDS), a rare group of cancers affecting bone marrow blood cells. Management also believes rigosertib has the potential to be developed as a therapeutic for other indications, such as AML, in the future. The company's ongoing Phase 3 INSPIRE trial is investigating IV-administered rigosertib as a second line treatment for higher risk MDS (HR-MDS). Onconova has also announced that it will commence a new Phase 3 combination trial with an oral formulation of rigosertib. The combination of these trials advancing concurrently in 2017 should provide a steady flow of clinical events, providing insight into the company's prospects. Additionally, Onconova enters 2017 with funding a cash position of $25.8mn and no financial debt as of the end of 3Q16, leaving it with what management has stated is sufficient funding to execute on its Phase 3 clinical plans for 2017.

Highlights from the report include:

Several potential catalysts ahead for Onconova enters 2017 funded to advance two Phase 3 clinical trials

We see several potential attributes for Onconova ahead in 2017. The company enters the year with a strong cash position, with $25.8mn of cash on its balance sheet at the end of 3Q16. Management expects this to be sufficient to fund the advancement of its ongoing INSPIRE Phase 3 clinical trials for rigosertib in IV-administered formulation as a second line therapy for higher risk MDS (HR-MDS). Also, in 2017 Onconova plans to advance the oral formulation of rigosertib to Phase 3 as a potential first line combination therapy for HR-MDS. With two Phase 3 trials in 2017, we would expect a steady stream of clinical updates throughout the year, in addition to business development activities for the company's non-core candidates.

Onconova enters 2017 with two Phase 3 clinical trials

We find ourselves enthused for several key clinical milestones ahead of Onconova. The company has made significant progress since disappointing trial results in 2014, and now boasts a pipeline highlighted by two Phase 3 clinical trials for its lead candidate, rigosertib. The trials are investigating rigosertib as a potential therapeutic for higher risk myelodysplastic syndromes (HR-MDS), a rare group of cancers affecting bone marrow blood cells, for which the FDA has not approved a new drug since 2006. Onconova's lead candidate has a differentiated method of action for treating HR-MDS, by targeting the RAS pathways, which play a key role in regulating cell growth and malignant transformation, and which management believes may have therapeutic potential for other indications, such as AML, in the future. With successful efficacy data, a case could be made for rigosertib as a second line treatment for HR-MDS patients who did not respond to hypomethylating agents (HMA), or as a first line therapy in combination with HMAs. Onconova management expects to report interim data during mid-2017 for its ongoing INSPIRE Phase 3 trial, with top-line data expected in 2018. The company also plans to disclose trial protocol for its Phase 3 combination trial for the oral formulation of rigosertib in 1H17.

Initiate coverage with a price target of $5.00

We initiate coverage of Onconova with a price target of $5.00. The company represents an intriguing, speculative company in the biopharmaceutical industry, with two Phase 3 clinical trials ahead for its lead product in 2017 and $25.8mn in cash and investments on its balance sheet as of 3Q16.

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About Onconova Therapeutics, Inc.

Onconova Therapeutics is a Phase 3 clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer. Onconova's clinical and pre-clinical stage drug development candidates are derived from its extensive chemical library and are designed to work against specific cellular pathways that are important in cancer cells, while causing minimal damage to normal cells. The Company's most advanced product candidate, rigosertib, is a small molecule inhibitor of cellular signaling and acts as a RAS mimetic. These effects of rigosertib appear to be mediated by direct binding of the compound to the RAS-binding domain (RBD) found in many RAS effector proteins, including the Raf and PI3 kinases. Rigosertib is protected by issued patents (earliest expiry in 2026) and has been awarded Orphan Designation for MDS in the United States, Europe and Japan. In addition to rigosertib, two other candidates are in the clinical stage, and several candidates are in pre-clinical stages. Onconova.com.

About INSPIRE

The INternational Study of Phase III IV RigosErtib, or INSPIRE, is based on guidance received from the U.S. Food and Drug Administration and European Medicines Agency and derives from the findings of the ONTIME Phase 3 trial. INSPIRE is a multi-center, randomized controlled study to assess the efficacy and safety of IV rigosertib in HR-MDS patients who had progressed on, failed to respond to, or relapsed after previous treatment with an HMA within the first nine months of initiation of HMA treatment. This time frame optimizes the opportunity to respond to treatment with an HMA prior to declaring treatment failure, as per NCCN Guidelines. The trial will enroll approximately 225 patients randomized at a 2:1 ratio into two treatment arms: IV rigosertib plus Best Supportive Care versus Physician's Choice plus Best Supportive Care. The primary endpoint of INSPIRE is overall survival and an interim analysis is anticipated. Full details of the INSPIRE trial, such as inclusion and exclusion criteria, as well as secondary endpoints, can be found on clinicaltrials.gov (NCT02562443).

About SeeThruEquity

Since its founding in 2011, SeeThruEquity has been committed to its core mission: providing impactful, high quality research on underfollowed smallcap and microcap equities. SeeThruEquity has pioneered an innovative business model for equity research that is not paid for and is unbiased. SeeThruEquity is the host of acclaimed investor conferences that are the ultimate event for publicly traded companies with market capitalizations less than $1 billion.

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