On January 9, 2020 Tmunity Therapeutics, Inc., a private clinical-stage biotherapeutics company focused on saving and improving lives by delivering the full potential of next-generation T-cell immunotherapy, reported that Usman "Oz" Azam, MD, President and Chief Executive Officer, will present at the 38th Annual J.P. Morgan Healthcare Conference on Wednesday, January 15, 2020 at 1:30 pm Pacific Time at the Westin St. Francis Hotel in San Francisco (Press release, Tmunity Therapeutics, JAN 9, 2020, View Source [SID1234552937]).

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A live webcast of the presentation will be available on the "Events and Presentations" page of the Tmunity website at View Source Tmunity will maintain an archived replay of the webcast on the website for 30 days after the conference.

On January 9, 2020 Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, reported that Sandy Macrae, CEO of Sangamo, will present a corporate overview at the 38th Annual J.P. Morgan Healthcare Conference on Thursday, January 16th at 8:30 a.m. PT in San Francisco (Press release, Sangamo Therapeutics, JAN 9, 2020, View Source [SID1234552936]).

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The presentation will be webcast live and may be accessed via a link on the Sangamo Therapeutics website in the Investors and Media section under Events and Presentations.

On January 9, 2020 SELLAS Life Sciences Group, Inc. (Nasdaq: SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, reported that it has entered into a securities purchase agreement with institutional investors to purchase approximately $6.5 million of its common shares (or pre-funded warrants to purchase common shares in lieu thereof) in a registered direct offering priced at-the-market under Nasdaq rules and warrants to purchase common shares in a concurrent private placement (Press release, Sellas Life Sciences, JAN 9, 2020, View Source [SID1234552932]). The combined purchase price for one common share (or pre-funded warrants to purchase common shares in lieu thereof) and a warrant to purchase 0.5 common shares will be $3.9825.

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Under the terms of the securities purchase agreement, SELLAS has agreed to sell 1,637,800 common shares (or pre-funded warrants to purchase common shares in lieu thereof). In a private placement, which will be consummated concurrently with the Offering, SELLAS also has agreed to issue warrants to purchase up to an aggregate of 818,900 common shares. The warrants will be immediately exercisable, will expire 5.5 years from the date of issuance and will have an exercise price of $3.93 per common share.

The gross proceeds to the Company from the registered direct offering and concurrent private placement is expected to be approximately $6.5 million before deducting the placement agents’ fees and other estimated offering expenses. The registered direct offering and concurrent private placement is expected to close on or about January 13, 2020, subject to the satisfaction of customary closing conditions.

Maxim Group LLC is acting as the sole placement agent in connection with the offering.

The common shares are being offered pursuant to a shelf registration statement on Form S-3 (File No. 333-233869) previously filed and declared effective by the Securities and Exchange Commission (SEC). The warrants issued in the concurrent private placement and shares issuable upon exercise of such warrants were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and have not been registered under the Act or applicable state securities law.

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. A prospectus supplement relating to the shares of common stock will be filed by SELLAS with the SEC. When available, copies of the prospectus supplement relating to the registered direct offering, together with the accompanying prospectus, can be obtained at the SEC’s website at www.sec.gov or from Maxim Group LLC, 405 Lexington Avenue, New York, NY 10174, Attention: Syndicate Department, or via email at [email protected] or telephone at (212) 895-3745.

On January 9, 2020 Presage Biosciences, a biotechnology company pioneering a new cancer drug development approach using its CIVO intratumoral microdosing platform, reported that the U.S. Food and Drug Administration (FDA) has approved its first Exploratory Investigational New Drug (IND) application for a Phase 0 study utilizing its CIVO platform (Press release, Presage Biosciences, JAN 9, 2020, View Source [SID1234552931]). The study, which will employ the CIVO platform to evaluate patients’ unique responses to microdoses of cancer drugs, is a collaboration with Takeda Pharmaceutical Company Limited (Takeda), with initiation planned in the first half of 2020.

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"The green light from the FDA for Presage’s first exploratory IND represents a major milestone as we seek to revolutionize early drug development through a superior approach to translational oncology," said Rich Klinghoffer, PhD, Presage CEO. "This latest success reflects our measured approach to building a long-term relationship with the FDA that will support our business model of making Phase 0 trials widely available to companies looking to gain deeper understanding of investigational drug response within the tumor microenvironment."

Takeda has previously partnered with Presage on preclinical mechanism of action and combination studies, including work highlighted by both companies at AACR (Free AACR Whitepaper) last year. "Takeda’s preclinical collaborations with Presage have been foundational to the honing of our translational insights into novel immuno-oncology agents," said Chris Arendt, Head, Oncology Therapeutic Area Unit, Takeda. "We are excited to now leverage the CIVO platform in the clinic and we are eager to see what insights this trial can provide and if intratumoral microdosing can enable biomarker studies that enrich and accelerate clinical translation."

"Takeda’s ongoing collaboration and support has enabled Presage to bring the CIVO platform into the clinic. We are very excited for this first trial to begin and demonstrate the possibilities for improving how oncology drug candidates are evaluated," added Klinghoffer.

Earlier this year, Presage announced collaborations with Celgene and BMS for Phase 0 trials with CIVO. Those trials are expected to commence in 2020 following FDA clearance. A recently completed clinical trial to evaluate the safety and feasibility of utilizing the CIVO platform demonstrated that CIVO is well tolerated and highlighted drug-specific tumor cell and microenvironment responses to both small molecule and biologic agents.

About CIVO and Phase 0 Trials

To address the challenges inherent in cancer drug discovery, Presage is advancing a new approach to rapidly evaluate multiple drug candidates and enhance knowledge applicable for future trial design. Exploratory Investigational New Drug studies, also known as Phase 0 trials, allow for the evaluation of minute amounts of drugs in patients to assess pharmacodynamic effects. CIVO is a patented platform that enables intratumoral microdosing and analysis of multiple cancer agents.

On January 9, 2020 Portola Pharmaceuticals, Inc. (Nasdaq: PTLA) reported preliminary unaudited Andexxa global net revenues for the fourth quarter and full year 2019 (Press release, Portola Pharmaceuticals, JAN 9, 2020, View Source [SID1234552930]). For the fourth quarter, the Company expects Andexxa global net revenues to be approximately $28 million. For the full year 2019, the Company expects Andexxa global net revenues to be approximately $111 million.

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In the U.S., net revenues of Andexxa in the fourth quarter 2019 were approximately $24 million, which compares to net revenues of $14.0 million in the same period a year ago and $33.0 million in third quarter 2019.

In Europe, net revenues of Ondexxya were approximately $4 million, which compares to net revenues of $2.7 million in the third quarter of 2019. Fourth quarter 2019 was Ondexxya’s first full quarter of sales following its launch in July 2019 in Europe, where it is now marketed in Germany, Austria, the U.K., the Netherlands, Sweden, Denmark and Finland.

During the fourth quarter, approximately 90 new accounts, and over 425 new accounts in 2019, ordered Andexxa in the U.S. This brings the total number of accounts now ordering Andexxa to approximately 640 at the end of 2019. There continues to be a significant hospital penetration opportunity within the Company’s 2,100 target accounts in 2020 and beyond. Also in the fourth quarter, re-ordering accounts contributed 80% of U.S. revenues, compared to 76% of revenues in the third quarter.

Fourth quarter Andexxa net sales in the U.S. were impacted primarily by two factors:

A $5 million gross to net adjustment due to a return reserve for short-dated product. The Company expects this to be mitigated going forward by its current longer-dated, 36-month product, which began shipping in November 2019.

Flat quarter over quarter demand due to a decrease in utilization, primarily in tier 1 accounts. While physician demand remains strong, the Company believes that in certain of these accounts, hospital pharmacies curtailed use of Andexxa following drug utilization reviews in an effort to manage pharmacy budgets. Following this reduction, re-ordering patterns are stabilizing in many of these accounts.

"While we are disappointed in the fourth quarter net revenues for Andexxa in the U.S., 2019 was a year of significant growth. We exceeded $100 million in revenues, including encouraging contributions from our global launch of Ondexxya, and Andexxa remains on track as one of the top five hospital drug launches in the U.S. in the last 30 years," said Scott Garland, Portola’s president and chief executive officer. "Our belief in the long-term potential of Andexxa remains

strong, and we maintain our projection that this highly innovative, orphan drug has an over $2 billion opportunity in the rapidly growing FXa-inhibitor market in the U.S. and Europe. We look forward to continuing to build long-term revenue growth and value for our shareholders as we establish Andexxa as the standard for care for doctors addressing the urgent needs of patients facing serious, life-threatening bleeds."

"Physician support for Andexxa and Ondexxya in the U.S. and Europe has been tremendous, and we continue to receive outstanding feedback from members of the medical community who have seen first-hand the benefits of Andexxa in treating DOAC-related bleeds," said Sheldon Koenig, Portola’s chief commercial officer. "The drug has excellent efficacy, works fast and is the only FDA-approved agent available. In 2020, we are moving aggressively to execute on our launch strategy and build greater awareness of the life-saving benefits of Andexxa by further educating hospitals on its value."

2020 Growth Drivers

The Company expects continued strong demand of Andexxa, driven by the growth of the Factor Xa inhibitor market in the U.S. and Europe. In 2019, the Factor Xa inhibitor market volume grew by 27% globally to reach $24 billion. In addition, growth in new hospital customers and deeper hospital utilization of Andexxa is expected in 2020 driven by:

Presentation and publication of newly generated health economics and outcomes research data at multiple medical meetings starting with three abstracts at the American College of Cardiology’s Annual Scientific Session together with the World Congress of Cardiology, showing the impact of Andexxa on inpatient mortality, burden of illness, budget impact model and cost effective analysis

Presentation and publication of data demonstrating 4-factor PCC’s, which are only approved to reverse warfarin, are not effective for reversing Factor Xa related bleeds

The launch of key educational initiatives to raise awareness of best practices for the various access and reimbursement pathways available, including: The New Technology Add-on Payment (NTAP) for Medicare beneficiaries in the inpatient setting; a pass through C-code for Medicare and commercial patients in the outpatient setting; participation in both Medicaid and the 340B drug pricing program; and consignment opportunities

Initiation of a single arm study in patients taking Factor Xa inhibitors that require urgent surgery, providing experience to inform the design of a randomized clinical trial

Conclusion of reimbursement discussions in European Wave 1 countries

Expansion of European launch into Wave 2 countries

The Company has a strong cash position to continue to invest in the launch of Andexxa and Ondexxya. As of December 31, 2019, the Company’s cash position totaled $464 million, compared with $317 million as of December 31, 2018.

These preliminary results are based on management’s initial analysis of operations for the quarter ended December 31, 2019. The Company expects to issue full financial results for the fourth quarter and fiscal year 2019 in late February.

Conference Call Details

The Company will host a live conference call on Thursday, January 9, 2020, at 5:00 p.m. ET, which can be accessed by phone by calling (844) 452-6828 from the United States and Canada or 1 (765) 507-2588 internationally and using the passcode 3995797. The webcast can also be accessed live on the Investor Relations section of the Company’s website at View Source

Corporate Update on January 14, 2020

As previously announced, Portola will provide a corporate update on Tuesday, January 14, at 7:00 a.m. PT (10:00 a.m. ET). The live webcast will be available on the Company’s website at View Source A replay of that presentation will remain available on the website after the live webcast.