On December 10, 2019 SCYNEXIS, Inc. (NASDAQ: SCYX) reported the pricing of its previously announced underwritten public offering of 38,888,889 shares of common stock and warrants to purchase up to 38,888,889 shares of common stock (Press release, Scynexis, DEC 10, 2019, View Source [SID1234552197]). Each share of common stock and warrant to purchase one share of common stock are being sold at a combined public offering price of $0.90 per share and accompanying warrant. The gross proceeds to SCYNEXIS from this offering are expected to be approximately $35 million, before deducting underwriting discounts and commissions and other estimated offering expenses, and excluding the exercise of any warrants. All of the shares of common stock and warrants are being offered by SCYNEXIS.

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H.C. Wainwright & Co. is acting as sole book-running manager for the offering.

The warrants will have an exercise price of $1.10 per share and exercise period commencing immediately upon issuance and an expiration date of the earlier of (i) such date that is six months after SCYNEXIS publicly announces the approval from the U.S. Food and Drug Administration for ibrexafungerp for the treatment of vulvovaginal candidiasis and (ii) June 12, 2023. There is no established public trading market for the warrants, and SCYNEXIS does not expect a market to develop.

In addition, SCYNEXIS has granted the underwriters a 30-day option to purchase up to an additional 5,833,333 shares of common stock and/or warrants to purchase up to 5,833,333 shares of common stock, at the public offering price, less the underwriting discounts and commissions. The offering is expected to close on or about December 12, 2019, subject to customary closing conditions. A shelf registration statement relating to the securities being sold in this offering was filed with the U.S. Securities and Exchange Commission (SEC) on August 31, 2018, and was declared effective on September 14, 2018. The offering is being made only by means of a prospectus supplement and accompanying prospectus. A preliminary prospectus supplement and accompanying prospectus relating to the offering were filed with the SEC and a final prospectus supplement and accompanying prospectus will be filed with the SEC and will be available for free on the SEC’s website located at View Source When available, electronic copies of the final prospectus supplement and accompanying prospectus relating to the public offering may be obtained by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, or by telephone at (646) 975-6996, or by email to [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, 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 December 10, 2019 Select Medical Holdings Corporation ("Holdings") (NYSE: SEM), reported that Select Medical Corporation ("Select") has completed its private placement of $675 million aggregate principal amount of its 6.250% Senior Notes due 2026 as additional notes (the "Additional Notes") under same indenture as Select’s existing $550 million aggregate principal amount of 6.250% senior notes due 2026 that were originally issued on August 1, 2019 and, as such, will form a single series and trade interchangeably with such previously issued notes (Press release, Select Medical, DEC 10, 2019, View Source;300972584.html [SID1234552213]).

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Selects intends to use a portion of the net proceeds of this offering, together with a portion of the net proceeds from a $615 million incremental term loan and, if required, available cash, to loan to its joint venture subsidiary, Concentra, Inc. ("Concentra"), pursuant to the terms of an intercompany loan agreement, an amount which will be used by Concentra to repay in full all currently outstanding term loan indebtedness under Concentra’s first lien credit agreement. Any remaining net proceeds from the offering will be used by Select for general corporate purposes.

The notes and related guarantees were sold in a private placement, solely to qualified institutional buyers in reliance on Rule 144A under the Securities Act of 1933, as amended (the "Securities Act"), or outside the United States to persons other than "U.S. persons" in compliance with Regulation S under the Securities Act. The notes and related guarantees have not been registered under the Securities Act or the securities laws of any other jurisdiction and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements.

This notice does not constitute an offer to sell the notes, nor a solicitation for an offer to purchase the notes, in any jurisdiction in which such offer or solicitation would be unlawful. Any offer of the notes will be made only by means of a private offering memorandum. This press release is being issued pursuant to and in accordance with Rule 135c under the Securities Act.

On December 10, 2019 Omeros Corporation (Nasdaq: OMER) reported an upcoming presentation directed to its novel cancer immunotherapy target GPR174 at the European Society for Medical Oncology 2019 Immuno-Oncology Congress, which is being held December 11-14, 2019 in Geneva, Switzerland (Press release, Omeros, DEC 10, 2019, View Source [SID1234552198]).

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In addition to previously presented ex vivo human and in vivo animal studies, the presentation will include new findings from human T-cells demonstrating that GPR174 inhibition results in downregulation of checkpoint and tumor promoting factors.

The poster (#108P) will be presented on December 12, 2019, at 12:15 PM local time by Marc Gavin, Ph.D., Omeros’ Director of Immunology.

On December 10, 2019 Syndivia, a biotechnology company focused on the development of new therapeutic modalities for solid cancers based on specific targeting of the tumour microenvironment and anatomical hallmarks, reported a €1 million investment from Cap Innov’Est, an inter-regionally based seed fund (Press release, Syndivia, DEC 10, 2019, View Source [SID1234552214]).

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This funding will enable Syndivia to advance its pipeline of proprietary anticancer therapies, including its lead drug candidate (SDV1001), thus completing the preclinical "proof of concept" study of the targeting of the microenvironment of solid tumours.

Sasha Koniev, Syndivia’s CEO, said, "We are very pleased to see Cap Innov’Est joining the company’s founders. This funding will allow us to advance our drug platform for both small-molecule and biologics, which have the unique potential to address a wide range of solid cancer indications by harnessing the specific properties of the tumor microenvironment."

Jean-François Rax, Investment Director at Cap Innov’Est said, "We are truly enthusiastic to be investing in such a promising company. We are convinced that Syndivia’s breakthrough approach in the hands of its experienced management team will be successful in delivering innovative and efficient treatments for cancer patients."

On December 10, 2019 Geron Corporation (Nasdaq: GERN) reported that two posters related to imetelstat, the Company’s first-in-class telomerase inhibitor, were presented at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in Orlando, Florida on December 8 and 9 (Press release, Geron, DEC 10, 2019, View Source [SID1234552199]). Both posters are available on Geron’s website at www.geron.com/r-d/publications.

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Trials in Progress Poster Presentation

Title: IMerge: A Study to Evaluate Imetelstat (GRN163L) in Transfusion-Dependent Subjects with IPSS Low or Intermediate-1 Risk Myelodysplastic Syndromes (MDS) That Is Relapsed/Refractory to Erythropoiesis-Stimulating Agent (ESA) Treatment (Abstract #4248)

The poster described key aspects of the IMerge Phase 2/3 clinical trial, including: the trial design; patient eligibility criteria; primary, secondary and exploratory endpoints; and the status of the trial. The poster also included a summary of previously presented data from the Phase 2 portion of the IMerge trial.

IMerge is an ongoing global two-part Phase 2/3 clinical trial of imetelstat in red blood cell (RBC) transfusion dependent patients with Low or Intermediate-1 risk, or lower risk myelodysplastic syndromes (MDS), who have relapsed after or are refractory to prior treatment with an erythropoiesis stimulating agent (ESA). The primary endpoint for the IMerge Phase 2/3 clinical trial is 8-week RBC transfusion independence (TI), which is defined as the proportion of patients achieving transfusion independence during any consecutive eight weeks since entry into the trial. Key secondary endpoints include the rate of transfusion independence lasting at least 24 weeks, or 24-week TI rate, durability of transfusion independence and the amount and relative change in transfusions.

IMerge Phase 3 Trial Now Enrolling

The IMerge Phase 3 is planned to enroll approximately 170 patients in a randomized, double-blind, placebo-controlled clinical trial. The trial will enroll non-del(5q) lower risk MDS patients who are naïve to treatment with hypomethylating agents (HMAs) and lenalidomide. The primary and secondary endpoints remain the same as the Phase 2 portion of the trial. Approximately 90 sites are planned to participate in 12 countries across North America, Europe, Middle East and Asia. Enrollment opened in August 2019, and the first patient was dosed in October 2019.

To learn more about the IMerge Phase 3 clinical trial and whether the study is enrolling patients in your area, please visit www.clinicaltrials.gov (NCT02598661).

IMerge Phase 2 Data Summary

Imetelstat treatment showed meaningful and durable transfusion independence in 38 non-del(5q) lower risk MDS patients who were naïve to HMAs and lenalidomide.
42% (16/38) of patients achieved ≥8-week RBC-TI
29% (11/38) of patients achieved ≥24-week RBC-TI
Median duration of TI was 85.9 weeks (range: 8.0-140.9)
68% (26/38) of patients achieved HI-E, or improvement in red blood cell count, as measured by either transfusion reduction or a rise in hemoglobin:
All 26 patients had a reduction of at least four RBC units over eight weeks compared with prior transfusion burden
12 patients had a hemoglobin increase of at least 1.5 g/dL lasting at least eight weeks
Mean relative reduction in transfusion burden from baseline was 68%
Transfusion independence was observed across different MDS patient subgroups.
Biomarker data suggested potential impact on malignant clone and disease modification by imetelstat treatment.
No new safety signals were identified. Reversible cytopenias were the most frequent adverse events.
Non-Clinical Data Poster Presentation

Title: Combination Treatment with Imetelstat, a Telomerase Inhibitor, and Ruxolitinib Depletes Myelofibrosis Hematopoietic Stem Cells and Progenitor Cells (Abstract #2963)

This poster presentation described results from early, nonclinical experiments on the potential effect of combining imetelstat and ruxolitinib on malignant myelofibrosis (MF) cells. The experiments explored the hypothesis that, due to different mechanisms of action, a combination of imetelstat and ruxolitinib might create a treatment regimen for MF that could be more efficacious than using either drug alone in reducing both malignant progenitor and stem cells. Ruxolitinib is a janus kinase (JAK) inhibitor that inhibits proliferation of malignant progenitor cells without eliminating malignant stem cells. Imetelstat is a telomerase inhibitor that selectively depletes malignant progenitor and stem cells.

In the experiments, the sequential treatment of ruxolitinib followed by imetelstat had additive inhibitory activity resulting in greater reductions in both malignant progenitor and stem cells when compared to simultaneous treatment or either drug alone. Furthermore, the sequential treatment regimen did not affect normal hematopoietic progenitor and stem cells. As stated in the poster, these non-clinical findings suggest that sequential treatment of ruxolitinib followed by imetelstat represents a potentially effective treatment that may eliminate both malignant MF progenitor and stem cells.

About Imetelstat

Imetelstat is a novel, first-in-class telomerase inhibitor exclusively owned by Geron and being developed in hematologic myeloid malignancies. Early clinical data suggest imetelstat may have disease-modifying activity through the suppression of malignant progenitor cell clone proliferation, which allows potential recovery of normal hematopoiesis. Ongoing clinical studies of imetelstat consist of IMerge, a Phase 2/3 trial in lower risk myelodysplastic syndromes (MDS), and IMbark, a Phase 2 trial in Intermediate-2 or High-risk myelofibrosis (MF). Imetelstat has been granted Fast Track designation by the United States Food and Drug Administration for both the treatment of patients with non-del(5q) lower risk MDS who are refractory or resistant to an erythropoiesis-stimulating agent and for patients with Intermediate-2 or High-risk MF whose disease has relapsed after or is refractory to janus kinase (JAK) inhibitor treatment.