On January 31, 2019 Leap Therapeutics, Inc. (Nasdaq: LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported that it has commenced an underwritten public offering of its common stock and warrants to purchase common stock (Press release, Leap Therapeutics, JAN 31, 2019, View Source [SID1234532994]). All shares of common stock and warrants to be sold in the offering will be offered by Leap. Leap intends to grant the underwriters a 30-day option to purchase up to an aggregate of an additional 15% of the shares of its common stock and/or warrants to purchase shares of its common stock offered in the public offering. The offering is subject to market, regulatory and other conditions and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Raymond James & Associates, Inc. and Ladenburg Thalmann will act as book-running managers for the offering.

Leap intends to use the net proceeds from the offering for general corporate purposes, which may include, without limitation, funding new clinical trials of DKN-01 and TRX518 and the continuation of ongoing studies, capital expenditures, working capital and general and administrative expenses.

The securities described above are being offered by the Company pursuant to an effective shelf registration statement on Form S-3 (File No. 333-223419) that was previously filed by Leap with the Securities and Exchange Commission (the "SEC") on March 2, 2018 and was declared effective by the SEC on March 16, 2018. A preliminary prospectus supplement and the related prospectus will be filed with the SEC and will be available for free on the SEC’s website at View Source Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering, when available, may be obtained from: Raymond James & Associates, Inc., Attention: Equity Syndicate, 880 Carillon Parkway, St. Petersburg, Florida 33716, or by telephone at (800) 248-8863, or e-mail at [email protected]; or from Ladenburg Thalmann, 277 Park Avenue, 26th Floor, New York, NY 10172, or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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 31, 2019 Repare Therapeutics, Inc., a privately held precision oncology company pioneering synthetic lethality to develop novel therapeutics that target specific vulnerabilities of tumors in clearly defined patient populations, reported that it has entered into an exclusive strategic research, development and commercialization partnership with ONO Pharmaceutical Co., Ltd., for Repare’s small molecule Polθ inhibitor program in Japan, South Korea, Taiwan, Hong Kong, Macau and ASEAN countries, excluding mainland China (Press release, Repare Therapeutics, JAN 31, 2019, View Source [SID1234532999]). Repare retains all rights to develop and commercialize the products outside the ONO territory, including the US, Canada and EU.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We’re excited to have ONO as a discovery and development partner," said Lloyd M. Segal, President and CEO of Repare. "This relationship will support our drive to and through the clinic in this important new area of precision oncology therapeutic development."

"ONO identified Repare Therapeutics as the partner of choice for bringing in a potential first-in-class and best-in-class Polθ inhibitor to our portfolio," said Gyo Sagara, President, Representative Director and CEO of ONO. "We are excited to work with Repare for the benefit of cancer patients."

Under the terms of the agreement, ONO will provide an up-front payment and research service payments potentially totaling US $15M, plus additional cost-sharing through IND. Beyond IND, significant clinical, regulatory and commercial milestones are also included in the agreement, with a potential total of US $160M. ONO will also pay to Repare high single-digit to low double-digit tiered royalties based on net sales of the product. Repare retains all rights to develop and commercialize the products outside the ONO territory, including the US, Canada and the EU.

Polθ inhibitor opportunity

DNA Polymerase θ (Polθ) is a unique, multifunctional DNA polymerase essential to repairing DNA breaks, especially in homologous recombination deficient (HRD) cells. HRD, including deficiency in the BRCA1 and BRCA2 genes, is a clinically important feature across a variety of important tumor types, including breast, ovarian, prostate and pancreatic cancers. Polθ gene expression is low in normal cells but elevated across a broad range of tumor types, including those with HRD. Currently, HRD tumors may be treated with Poly(ADP-ribose) Polymerase (PARP) inhibitors, which represent a rapidly growing, multi-billion dollar global market. A significant fraction of patients does not initially respond to PARP inhibitor treatment, and the vast majority of treated patients eventually develop PARP inhibitor resistance. A Polθ inhibitor has potential as both a mono-therapy across multiple tumor types and in combination with PARP inhibitors, where its distinct mechanism of action may help address both forms of PARP resistance. Additional clinical populations may also be attractive for combination treatment with a Polθ inhibitor, including possible combinations with chemotherapy, radiotherapy and Immuno-Oncology agents