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 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.

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"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

On January 30, 2019 4SC AG (4SC, FSE Prime Standard: VSC) reported the enrollment of the first patient in the third dose cohort of the ongoing Phase Ib/II study SENSITIZE (Press release, 4SC, JAN 30, 2019, View Source [SID1234532963]).

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The SENSITIZE study (ClinicalTrials.gov identifier: NCT03278665) is enrolling up to 40 patients suffering from unresectable advanced-stage cutaneous melanoma who are refractory or non-responding to prior treatment with anti-PD-1 antibodies (checkpoint inhibitors).

In the first part of the study, three patient cohorts will be treated at three different dose levels of domatinostat in combination with pembrolizumab. In the second part, additional patients will be treated with the recommended dosing regimen defined in the first dose-finding part of the study. 4SC anticipates first data to be available in H1 2019.

Jason Loveridge, Ph.D., CEO of 4SC: "Enrolling the first patient in the third dose cohort of the SENSITIZE study again is a significant milestone for 4SC and the study is continuing steadily. We are convinced that the combination of domatinostat with checkpoint inhibitors is the best route to most rapidly progress domatinostat towards market approval. With this, as well as the investigator-sponsored Phase II study EMERGE in advanced gastrointestinal cancer, we continue to build momentum and execute on our plan, which is intended to lead to the initiation of a potentially pivotal trial in 2019."

On January 30, 2019 BioInvent International AB (OMXS: BINV) reported that the U.S. Food and Drug Administration (FDA) has granted the Company orphan designation for its proprietary antibody BI-1206 for the treatment of mantle cell lymphoma (MCL) (Press release, BioInvent, JAN 30, 2019, View Source [SID1234532964]).

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Orphan designation is intended to support companies developing treatments that target rare medical conditions and are expected to provide significant therapeutic advantage over existing medicines. The orphan designation from the FDA provides certain incentives to BioInvent, including a 7-year market exclusivity in the U.S once a New Drug Application (NDA) or Biologics License Application (BLA) has been approved, and also availability of grants exclusively for orphan drug products.

BioInvent is currently conducting a dose escalation, consecutive-cohort, open-label Phase I/IIa study of BI-1206 with approximately 30 patients across sites in the EU and the U.S. The trial evaluates BI-1206 in combination with rituximab in patients with indolent relapsed or refractory B-cell non-Hodgkin’s lymphoma (NHL). MCL is one of the targeted sub-indications, along with follicular lymphoma (FL) and marginal zone lymphoma (MZL).

"This orphan designation for BI-1206 is very good news for BioInvent, and most importantly for patients suffering from this very serious condition. There is a significant unmet medical need, as there are presently few treatment options for patients suffering from mantle cell lymphoma. We are looking forward to generating data from our Phase I/IIa trial to support the use of BI-1206 in combination with rituximab in this indication," says Martin Welschof, CEO of BioInvent.