On January 31, 2019 Onconova Therapeutics, Inc. (Nasdaq: ONTX), a Phase 3 stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, with a primary focus on Myelodysplastic Syndromes (MDS), reported it will host a KOL breakfast for security analysts and institutional investors on Thursday, February 7, 2019, in New York City (Press release, Onconova, JAN 31, 2019, View Source [SID1234532975]).

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The event will include presentations by Lewis Silverman, MD, Associate Professor of Medicine and Director of the Translational Research Center for the Myelodysplastic Syndrome in the Division of Hematology/Oncology/Tisch Cancer Institute and Rajwanth Veluswamy, MD, MSCR, Assistant Professor of Medicine, Thoracic Oncology, Tisch Cancer Institute, Institute for Translational Epidemiology, Icahn School of Medicine, Mount Sinai Health System. In addition, Steven Fruchtman, MD, President and Chief Executive Officer of Onconova, will present a Company overview and detailed information from the Company’s Phase 2 rigosertib trial and the Company’s clinical strategy and near-term milestones.

Presentations will begin at 8:00 a.m. Eastern Standard Time. A live and archived audio and slide webcast of the event will be available on Onconova’s Corporate Events and Presentations page. Following the presentations, all speakers will be available for questions. This on-site event is open to analysts and institutional investors only. Kindly RSVP in advance if you would like to attend in person, as space is limited. To request a spot, please send an email to [email protected].

"We are excited to host this important educational event on recent advances in the treatment of myelodysplastic syndromes and other RAS-mutated cancers, and honored that two prominent research leaders in their field, Dr. Lewis Silverman, a recognized expert in MDS, and Dr. Rajwanth Veluswamy, a prominent researcher and clinician in lung cancer, have agreed to speak," said Steven M. Fruchtman, MD, President and Chief Executive Officer of Onconova. "In addition to the presentations by Drs. Silverman and Veluswamy, we will be discussing our Phase 2 oral rigosertib data, which were recently presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in December. We will also discuss future plans and near-term milestones, including pivotal Phase 3 data with IV rigosertib in high-risk MDS patients."

Key findings from the Phase 2 trial data presented at ASH (Free ASH Whitepaper) include:

Overall response rate (ORR) of 90% reported in this multi-institutional Phase 2 study in hypomethylating agent (HMA) naïve patients, including Complete Remission (CR) rate of 34%
Median duration of response for the HMA naïve patients was 12.2 months
Acceptable safety profile when oral rigosertib is combined with the FDA-approved dose of azacitidine
KOL Event Presentation Highlights

Participating Key Opinion Leaders

Lewis R. Silverman, MD, is an Associate Professor of Medicine and Director of the Myelodysplastic Syndrome and Myeloproliferative Disease Program, Mount Sinai School of Medicine, in New York City. He served as Principal Investigator of the randomized Phase 3 trial of azacitidine vs. Supportive Care, which served as the basis for approval of azacitidine by the FDA for MDS in the United States. Dr. Silverman is a pioneer in developing treatments for patients with Higher-risk MDS and has served as a Principal Investigator on Onconova’s rigosertib clinical trial program for treatment of Higher-risk MDS patients.

Rajwanth R. Veluswamy, MD, MSCR, is an Assistant Professor of Medicine, Hematology and Medical Oncology, and a board-certified medical oncologist who specializes in the treatment of lung cancer and other thoracic malignancies. He completed both a clinical fellowship in Hematology and Medical Oncology and a General Medicine research fellowship at the Icahn School of Medicine at Mount Sinai. Prior to this, he completed residency in Internal Medicine at Methodist Dallas Medical Center, and a research internship at MD Anderson Cancer Center in Houston.

New developments in the treatment of MDS and the rigosertib clinical trial program
New approaches for the treatment of RAS-mutated lung cancers
Phase 2 efficacy and safety results of oral rigosertib in combination with azacitidine (Vidaza) in high-risk MDS patients, as reported at the 2018 annual meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper)
Onconova’s rigosertib clinical program – the broadest in myelodysplastic syndromes

On January 31, 2019 Pulmatrix, Inc. ("Pulmatrix," the "Company," "we," "our" or "us") (NASDAQ: PULM) reported the closing and funding of its previously announced underwritten public offering of 1,561,177 shares of its common stock at a price to the public of $0.17 per share (Press release, Pulmatrix, JAN 31, 2019, View Source [SID1234532995]). The gross proceeds from the offering, before deducting the underwriting discounts and commissions and estimated offering expenses are $265,400.

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Pulmatrix currently intends to use the net proceeds from the offering for working capital and general corporate purposes.

A shelf registration statement on Form S-3 (Registration No. 333-212546) relating to the public offering of the shares of common stock described above was filed with the Securities and Exchange Commission ("SEC") and was declared effective on August 3, 2016. A prospectus supplement describing the terms of the offering was filed with the SEC on January 29, 2019, and is available on the SEC’s website at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained from H.C. Wainwright & Co., LLC, 430 Park Avenue 3rd Floor, New York, NY 10022, or by calling (646) 975-6996 or by emailing [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction. Any offer, if at all, will be made only by means of the prospectus supplement and accompanying prospectus forming a part of the effective registration statement.

On January 31, 2019 Corcept Therapeutics Incorporated (NASDAQ: CORT), a company engaged in the discovery, development and commercialization of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol, reported preliminary fourth quarter revenue of $66.8 million, compared to $53.3 million in the fourth quarter of 2017 (Press release, Corcept Therapeutics, JAN 31, 2019, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-announces-fourth-quarter-and-full-year-2018 [SID1234532998]). Preliminary 2018 revenue was $251.2 million, an increase of 58 percent from 2017. Corcept projects 2019 revenue of $285 – $315 million. These results are prior to the completion of the company’s annual independent audit and are subject to adjustment.

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Cash and investments increased by $10.1 million in the fourth quarter, to $206.8 million. This increase was after the expenditure of $14.8 million to acquire 1.1 million shares of the company’s common stock pursuant to its stock repurchase program. Under the terms of the program as currently authorized, $76.3 million remains available for the repurchase of shares.

"Our Cushing’s syndrome franchise grew significantly in 2018, as more physicians prescribed Korlym for the first time and experienced prescribers identified additional patients who could benefit from the medication," said Joseph K. Belanoff, MD, Corcept’s Chief Executive Officer. "We expect the increase in first-time and repeat Korlym prescribers to continue in 2019.

"Korlym’s robust revenue has allowed us, and will continue to allow us, to advance our proprietary selective cortisol modulators as potential treatments in a wide variety of serious disorders. Relacorilant, our candidate to succeed Korlym, began Phase 3 last year. In 2019, we plan to start Phase 2 trials in patients with metastatic ovarian, pancreatic and castration-resistant prostate cancers, non-alcoholic steatohepatitis (NASH) and antipsychotic-induced weight gain. These programs represent the future of Corcept."

Hypercortisolism

Hypercortisolism, often referred to as Cushing’s syndrome, is caused by excessive activity of the stress hormone cortisol. Endogenous Cushing’s syndrome is an orphan disease that most often affects adults aged 20-50. In the United States, an estimated 20,000 patients have Cushing’s syndrome, with about 3,000 new patients being diagnosed each year. Symptoms vary, but most people experience one or more of the following manifestations: high blood sugar, diabetes, high blood pressure, upper-body obesity, rounded face, increased fat around the neck, thinning arms and legs, severe fatigue and weak muscles. Irritability, anxiety, cognitive disturbances and depression are also common. Cushing’s syndrome can affect every organ system in the body and can be lethal if not treated effectively.

On January 30, 2019 NewLink Genetics Corporation (NASDAQ:NLNK) reported that the Company’s Chairman, CEO and Chief Scientific Officer, Charles J. Link, Jr, MD, will participate in the Immuno-Oncology 360° Conference (IO360°) being held February 6 – 9, 2019 at the Crowne Plaza Times Square in New York, New York (Press release, NewLink Genetics, JAN 30, 2019, View Source [SID1234532961]).

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Dr. Link’s presentation, "IDO Changes the T-cell Balance in the Tumor Microenvironment," will occur on Wednesday, February 6th, at 9:15 AM ET, and will include a discussion of immune regulation in the tumor microenvironment and how indoximod’s mechanism of action lends itself to counter multiple elements of immune regulation.

Additional information may be found on the IO360°website. The presentation slides will be available on the NewLink Genetics website at www.newlinkgenetics.com in the "Investors & Media" section under "Events & Presentations" once the presentation has begun.

On January 30, 2019 BioTime, Inc. (NYSE American: BTX), a clinical-stage biotechnology company focused on degenerative diseases, reported that its affiliate company, OncoCyte Corporation (OncoCyte) (OCX), a developer of novel, non-invasive tests for the early detection of cancer, has reported positive results from an R&D validation study of DetermaVu, a non-invasive, liquid biopsy test intended to facilitate clinical decision making in lung cancer diagnosis (Press release, BioTime, JAN 30, 2019, View Source;p=RssLanding&cat=news&id=2385346 [SID1234532977]). As outlined in OncoCyte’s announcement, the R&D validation study demonstrated a sensitivity of 90% (95% CI 82%-95%) and specificity of 75% (95% CI 68%-81%) of DetermaVu on a prospectively collected cohort of 250 patient blood samples that were blinded to laboratory operators. A 95% confidence interval (CI) suggests that there is a 95% chance that test performance will be within the stated range.

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According to OncoCyte, these results indicate that DetermaVu significantly exceeds the critical parameters necessary for use in lung cancer diagnosis and clearly outperforms reported results from competitors’ tests and other clinical models. OncoCyte believes that the potential U.S. market opportunity for DetermaVu is $4.7 billion. OncoCyte intends to make DetermaVu commercially available in the second half of 2019.

"As the largest shareholder of OncoCyte, we wish to congratulate the entire team on obtaining positive results from the validation study of DetermaVu which were announced yesterday morning," stated Brian M. Culley, Chief Executive Officer of BioTime, Inc. "BioTime owns approximately 36% of Oncocyte’s outstanding common stock and we look forward to the commercial launch of DetermaVu which OncoCyte expects to occur later this year."

DetermaVu is OncoCyte’s confirmatory, non-invasive, liquid biopsy test intended to facilitate clinical decision making in lung cancer diagnosis. DetermaVu is being developed as a confirmatory test for presence or absence of lung cancer to reduce the need for unnecessary invasive biopsies when suspicious lung nodules are detected by imaging modalities such as x-rays or other scans. DetermaVu is a trademark of OncoCyte Corporation.