On October 11, 2018 Emergent BioSolutions Inc. (NYSE: EBS) reported that it will host a conference call on Thursday, November 1, 2018 at 5:00 pm (Eastern Time) to discuss the financial results for the third quarter of 2018, recent business developments, revenue guidance for the fourth quarter of 2018, and revenue and net income guidance for full year 2018 (Press release, Emergent BioSolutions, OCT 11, 2018, View Source;p=RssLanding&cat=news&id=2371215 [SID1234529870]).

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This conference call can be accessed live by telephone or by webcast:

Live Teleconference Information:
Dial in number: (855) 766-6521
International dial in: (262) 912-6157
Conference ID: 93346559

Live Webcast Information:
Visit View Source for the live webcast feed.

A replay of the call can be accessed on Emergent’s website emergentbiosolutions.com under "Investors."

On October 11, 2018 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, reported the pricing of $150 million aggregate principal amount of its 3.00% convertible senior notes due 2025 (the "Notes") (Press release, Karyopharm, OCT 11, 2018, View Source [SID1234530278]). The Notes will be sold in a private offering to qualified institutional buyers in reliance on Rule 144A under the Securities Act of 1933, as amended (the "Securities Act"). Karyopharm also granted to the initial purchasers of the Notes a 13-day option to purchase up to an additional $22.5 million aggregate principal amount of the Notes. The offering is expected to close on or about October 16, 2018, subject to satisfaction of customary closing conditions.

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The Notes will be unsecured, senior obligations of Karyopharm, and will bear interest at a rate of 3.00% per annum, payable semi-annually in arrears on April 15 and October 15 of each year, beginning on April 15, 2019. The Notes will mature on October 15, 2025, unless earlier repurchased, redeemed or converted in accordance with their terms. Subject to certain conditions, on or after October 15, 2022, Karyopharm may redeem for cash all or a portion of the Notes at a redemption price equal to 100% of the principal amount of the Notes to be redeemed, plus accrued and unpaid interest, if any, to, but excluding, the redemption date. The Notes will be convertible at the option of holders of the Notes, upon satisfaction of certain conditions and during certain periods, into cash, shares of Karyopharm’s common stock, or a combination of cash and shares of Karyopharm’s common stock, at Karyopharm’s option. The conversion rate for the Notes will initially be 63.0731 shares of Karyopharm’s common stock per $1,000 principal amount of Notes, which is equivalent to an initial conversion price of approximately $15.85 per share. This represents a premium of approximately 27.5% over the last reported sale price of $12.435 per share of Karyopharm’s common stock on The Nasdaq Global Select Market on October 10, 2018. The conversion rate will be subject to adjustment upon the occurrence of certain events.

Karyopharm estimates that the net proceeds from the sale of the Notes will be approximately $145.1 million (or approximately $167.0 million if the initial purchasers exercise their option to purchase additional Notes in full), after deducting the initial purchasers’ discounts and commissions and estimated offering expenses payable by Karyopharm. Karyopharm intends to use the net proceeds from the sale of the Notes: to continue establishing the infrastructure to support the potential commercial launch of selinexor; to support continued clinical development of selinexor in hematologic malignancies and solid tumors; to conduct ongoing activities to support regulatory submissions for oral selinexor as a new treatment for patients with penta-refractory multiple myeloma and, if the results of Karyopharm’s SADAL trial are positive, as a new treatment for patients with relapsed/refractory diffuse large B-cell lymphoma; for clinical trials of two of Karyopharm’s pipeline drug candidates in oncology, eltanexor and KPT-9274; and for working capital and other general corporate purposes.

The Notes will be offered and sold to qualified institutional buyers pursuant to Rule 144A under the Securities Act. The offer and sale of the Notes and the shares of common stock issuable upon conversion of the Notes, if any, have not been and will not be registered under the Securities Act or the securities laws of any other jurisdiction, and the Notes and any such shares may not be offered or sold in the United States absent registration or an applicable exemption from such registration requirements. Any offer of the Notes will be made only by means of a private offering memorandum.

This press release does not constitute an offer to sell or the solicitation of an offer to buy the Notes or any other securities, nor shall there be any offer, solicitation or sale of the Notes or any other securities (including the shares of Karyopharm’s common stock issuable upon conversion of the Notes, if any) in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful

On October 11, 2018 Spherix Incorporated (Nasdaq: SPEX) reported that it has entered into a merger agreement with CBM BioPharma, Inc. ("CBM") that will transform Spherix into an innovative pharmaceutical company with pioneering drugs and treatments focused on the multibillion dollar oncology therapeutics market.

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CBM is a privately held pharmaceutical company with exclusive drug development rights from world-renowned partners including Wake Forest Innovations and the University of Texas at Austin. CBM has a team of leading drug development scientists who will be joining Spherix as advisors to advance the technology. The CBM platform focuses on the treatment of numerous cancers, including acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), and pancreatic cancer.

Two specific proprietary drugs that are currently being researched are:

KPC34 (Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia)

Developed at Wake Forest School of Medicine, AML and ALL drug, KPC34, is a next generation treatment designed to overcome multiple resistance challenges observed with the current standard of care. KPC34 has also been shown to be more effective in AML relapse cases, notably increasing the lifespan of mice treated with the drug.

One competitive benefit of KPC34 includes its ability to be orally administered. This is critical for patients that are unable to tolerate repeated cycles of chemotherapy. In addition, it has served to double the mean survival time versus the current standard of care treatments in a mouse model of leukemia.
DHA-dFdC (Pancreatic Cancer Drug)

Developed at the University of Texas at Austin, DHA-dFdC has shown positive results in preclinical studies, inhibiting pancreatic tumor growth in clinically relevant transgenic mouse models. DHA-dFdC also overcomes tumor cell resistance to current chemotherapeutic drugs. Pancreatic cancer is a deadly disease that affects millions of people around the world.

The following doctors will be supporting the efforts of Spherix, after the completion of the merger:

Dr. Timothy S. Pardee, MD, PhD, an Associate Professor of Internal Medicine, Section on Hematology and Oncology and Cancer Biology and Director of Leukemia Translational Research at Wake Forest School of Medicine. Dr. Pardee stated, "I am very excited at the possibility of bringing KPC34 to the clinic in early phase clinical trials. As a physician scientist who treats acute leukemia patients, I know firsthand the clear unmet medical need for relapsed patients."

Dr. Gregory Kucera, a Professor of Internal Medicine at the Wake Forest University School of Medicine with over 28 years of research experience on novel therapeutics for cancer treatment. His laboratory has expertise in synthesizing therapeutics, lipid biochemistry, and in vitro drug testing. Dr. Kucera stated, "As a research scientist, the satisfaction of seeing a compound like KPC34 go from the laboratory to an early stage clinical trial is immense. I have a great sense of pride in knowing that the work done by our research team has produced a drug that may benefit cancer patients in the very near future."

Joining Spherix as Chief Science Officer to oversee clinical advancement of these drugs is Dr. Tom Wilkie who is an Associate Professor of Pharmacology at the University of Texas Southwestern Medical Center in Dallas. He earned both his BA at the University of California Berkeley and his PhD with Richard Palmiter at UW Seattle, in biochemistry. Wilkie has published 74 primary research papers and reviews, serves on NIH, CIRM, and AACR (Free AACR Whitepaper) grant review study sections. He reviews manuscripts for multiple journals, and is Director of the first-year graduate student core course at UT Southwestern.

Dr. Wilkie stated, "I’m delighted to join Spherix as Chief Science Officer. The agreement between Spherix Incorporated and CBM BioPharma will advance the exciting potential for improving the lives of patients, family, friends, and ultimately, all of us. Proposals for the next phase of testing are underway."

Dr. Robert J. Vander Zanden, Spherix’s Chairman of the Board, stated, "Spherix is extremely pleased to announce this merger with CBM, as we believe it serves as a necessary step in our transition to a diversified biopharmaceutical company. This deal builds upon our investment in Hoth Therapeutics, which owns several exciting assets in various stages of development."

Anthony Hayes, CEO of Spherix stated, "We are very excited to welcome CBM BioPharma and its team to Spherix. It is an exciting and transformational time for the Company. Spherix will pay $16.5 million in stock for 100% of CBM by issuing 15 million Spherix shares to CBM at a fixed price of $1.10 per share. I look forward to sharing more information with our shareholders about the merger in the upcoming weeks, via investor outreach and our upcoming SEC filings."

On October 11, 2018 Altimmune, Inc. (Nasdaq: ALT), a clinical-stage immunotherapeutics company, reported it has closed a registered direct offering of common units and pre-funded units for gross proceeds of approximately $25 million (Press release, Altimmune, OCT 11, 2018, View Source [SID1234529903]). Together with Altimmune’s registered direct offering announced on September 24 and follow-on offering announced September 28, the company received aggregate gross proceeds of $41.9 million.

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"We are pleased with the outcome of our fundraising efforts," said William J. Enright, President and Chief Executive Officer of Altimmune. "These proceeds strengthen our balance sheet and position us well as we continue the development of NasoVax and our other product candidates."

Altimmune intends to use the proceeds from these offerings for the continued advancement of development activities for the Company’s clinical-stage product pipeline, general corporate purposes, strategic growth opportunities and repayment of the Company’s outstanding $1.5 million in aggregate principal amount of convertible notes.

ROTH Capital Partners acted as sole manager for the underwritten public offering and sole placement agent for both registered direct offerings.

On October 11, 2018 Context Therapeutics reported Phase 1 data for its investigational new drug, Apristor (Onapristone extended release), an oral progesterone receptor antagonist that is being developed for progesterone receptor-positive (PR+) cancers (Press release, Context Therapeutics, OCT 11, 2018, View Source [SID1234529858]). Data from the study showed that Apristor, a novel extended release formulation of onapristone, was well tolerated and provided a clinical benefit in patients with previously treated recurrent or metastatic progesterone receptor-driven breast, ovarian and endometrial cancers. These findings were published in the medical journal PLOS One and can be accessed here.

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"I’m encouraged by the early data seen in this Phase 1 study of Apristor. Apristor appears to be well tolerated, with responses seen across a broad range of PR+ cancers," commented Paul Cottu, M.D., Ph.D., Deputy Head, Department of Oncology, Institute Curie, and lead investigator for the trial. "Many hormonally-driven malignancies are difficult to treat, and new agents are clearly needed. Targeted therapies, including Apristor, have the potential not only to add therapeutic options for our patients but also to reduce or delay the need for chemotherapy, possibly changing the way many of these malignancies are treated."

"Context is pleased with the Phase 1 Apristor study results demonstrating clinical efficacy across PR+ cancers in heavily pretreated patients who are typically unresponsive to currently approved hormonal treatments," stated Martin Lehr, CEO of Context Therapeutics. "We believe Apristor has the potential to be the first anti-progestin approved to treat cancer and we are rapidly advancing Apristor into multiple Phase 2 trials with a goal of addressing significant medical needs."

Apristor Phase 1 Data in Patients with PR+ Breast, Ovarian, or Endometrial Cancer

Design

52 patients were randomized to five cohorts of Apristor (onapristone extended release tablets 10, 20, 30, 40 or 50 mg BID; n=46), or immediate release onapristone 100 mg QD (n=6) until progressive disease or intolerability. Primary endpoint was to identify the recommended phase 2 dose. Secondary endpoints included safety, clinical benefit and pharmacokinetics.

Results

Tumor diagnosis includes: endometrial carcinoma 12; breast cancer 20; ovarian cancer 13; and other 7. Median age was 64 (36-84). No dose limiting toxicity was observed with reported liver function test elevation related only to liver metastases. The recommended Phase 2 dose (RP2D) was 50mg BID. For patients on Apristor (n=46), dose responsive activity was noted, and 20% (9 of 46) patients had clinical benefit ≥24 weeks. The most common side effects were asthenia and low-grade, transient gamma-glutamyl transferase elevations.

Clinical Activity

Tumor assessments strongly suggested anti-cancer efficacy, even in heavily pretreated patients. In Apristor treated patients, 20 of 46 patients experienced stable disease as best response and 9 of 46 patients had durable disease stabilization.

Conclusions

The new extended release formulation of Onapristone (Apristor) was well tolerated and resulted in clinical benefit in heavily pretreated patients with ovarian, breast and uterine endometrial cancers. The recommended Phase 2 dose for Apristor is 50mg BID. There were no grade 3-4 LFT elevations in the absence of progressive liver metastases, no new safety signals were observed, and dose limiting toxicity was not observed. The data support the development of Apristor in PR+ cancers.

About Apristor

Apristor, an investigational new drug, is an oral progesterone receptor (PR) antagonist. PR is an oncogene that is enriched in up to 70% of all breast, ovarian, and endometrial cancers. Apristor is being developed to treat metastatic breast, ovarian and endometrial cancers.