On May 20, 2021 Checkmate Pharmaceuticals Inc. (NASDAQ: CMPI) ("Checkmate"), a clinical stage biopharmaceutical company focused on developing its proprietary technology to harness the power of the immune system to combat cancer, reported that Barry Labinger, CEO, will present at the Jefferies Virtual Healthcare Conference from 2:00-2:25pm ET on Tuesday, June 1, 2021 (Press release, Checkmate Pharmaceuticals, MAY 20, 2021, View Source [SID1234580446]). Checkmate will also host 1×1 investor meetings during the conference.

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A live webcast of the presentation can be accessed under "Events & Presentations" in the Investors section of the Checkmate website. An archived copy of the webcast will be available on the Checkmate website for approximately 30 days after the event.

On May 20, 2021 Seelos Therapeutics, Inc. (Nasdaq: SEEL), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system (CNS) disorders and rare diseases, reported the pricing of an underwritten public offering of 19,354,840 shares of its common stock, at a price to the public of $3.10 per share (Press release, Apricus Biosciences, MAY 20, 2021, View Source [SID1234580445]). In addition, the Company granted the underwriters a 30-day option to purchase up to 2,903,226 additional shares of its common stock. All of the shares of common stock in the offering are being sold by Seelos.

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Guggenheim Securities and Cantor are serving as joint book-running managers for the offering. BTIG is serving as lead manager for the offering. The Benchmark Company acted as a financial advisor for the offering.

Seelos anticipates the aggregate net proceeds from the offering will be approximately $56.1 million, after deducting the underwriting discounts and commissions and estimated offering expenses payable by Seelos, but excluding any exercise of the underwriters’ option to purchase additional shares of common stock. Seelos intends to use an aggregate of $6.3 million of the net proceeds from the offering for the partial repayment of certain outstanding convertible promissory notes and the remainder for general corporate purposes and to advance the development of its product candidates. This offering is expected to close on or about May 24, 2021, subject to the satisfaction of customary closing conditions.

The securities described above were offered by Seelos pursuant to an effective "shelf" registration statement on Form S-3 (File No. 333-251356) previously filed with the Securities and Exchange Commission (the "SEC") on December 15, 2020, amended on December 22, 2020 and declared effective by the SEC on December 23, 2020. The securities may be offered only by means of a prospectus. A preliminary prospectus supplement and the accompanying prospectus relating to and describing the offering has been filed with the SEC. Electronic copies of the preliminary prospectus and, when available, copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained by visiting the SEC’s website at www.sec.gov or by contacting Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, by calling (212) 518-9544 or by e-mail at [email protected].

This press release does 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 state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

On May 20, 2021, Pieris Pharmaceuticals, Inc. (the "Company") and Biotechnology Value Fund, L.P., Biotechnology Value Fund II, L.P., and Biotechnology Value Trading Fund OS, L.P. (collectively, "BVF") reported that entered into an Exchange Agreement (the "Exchange Agreement") pursuant to which BVF agreed to exchange (the "Exchange") an aggregate of 5,000,000 shares of the Company’s common stock, par value $0.001 ("Common Stock"), owned by BVF for an aggregate of 5,000 shares of the Company’s newly-designated Series E Convertible Preferred Stock, a "toothless" preferred stock, par value $0.001 per share ("Series E Preferred Stock") (Filing, 8-K, Pieris Pharmaceuticals, MAY 20, 2021, View Source [SID1234580441]). The Exchange closed on May 21, 2021.

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As described below, the Series E Preferred Stock has substantially the same terms as the Company’s Series D Convertible Preferred Stock, par value $0.001 per share ("Series D Preferred Stock"), issued in March 2020; Series C Convertible Preferred Stock, par value $0.001 per share ("Series C Preferred Stock"), issued in November 2019; Series B Convertible Preferred Stock, par value $0.001 per share ("Series B Preferred Stock"), issued in January 2019; and Series A Convertible Preferred Stock, par value $0.001 per share ("Series A Preferred Stock"), issued in June 2016, all currently held by entities affiliated with BVF. The shares of Series E Preferred Stock issued in the Exchange are convertible into an aggregate of 5,000,000 shares of Common Stock (subject to adjustment as provided in the Series E Certificate of Designation, as defined below), subject to a 9.99% beneficial ownership blocker provision described below.

As of the date of the Exchange Agreement, BVF represented to the Company that it beneficially owned 5,872,762 shares of Common Stock, representing approximately 9.28% of the shares of Common Stock outstanding as of such date. In addition, BVF holds (i) 2,907 shares of Series A Preferred Stock, which are convertible into 2,907,000 shares of Common Stock (subject to adjustment as provided in the Certificate of Designation of Series A Convertible Preferred Stock of Pieris Pharmaceuticals, Inc. (the "Series A Certificate of Designation")), subject to a 9.99% beneficial ownership blocker provision set forth in the Series A Certificate of Designation; (ii) 5,000 shares of Series B Preferred Stock, which are convertible into 5,000,000 shares of Common Stock (subject to adjustment as provided in the Certificate of Designation of Series B Convertible Preferred Stock of Pieris Pharmaceuticals, Inc. (the "Series B Certificate of Designation")), subject to a 9.99% beneficial ownership blocker provision set forth in the Series B Certificate of Designation; (iii) 3,522 shares of Series C Preferred Stock, which are convertible into 3,522,000 shares of Common Stock (subject to adjustment as provided in the Certificate of Designation of Series C Convertible Preferred Stock of Pieris Pharmaceuticals, Inc. (the "Series C Certificate of Designation")), subject to a 9.99% beneficial ownership blocker provision set forth in the Series C Certificate of Designation; and (iv) 3,000 shares of Series D Preferred Stock, which are convertible into 3,000,000 shares of Common Stock (subject to adjustment as provided in the Certificate of Designation of Series D Convertible Preferred Stock of Pieris Pharmaceuticals, Inc. (the "Series D Certificate of Designation")), subject to a 9.99% beneficial ownership blocker provision set forth in the Series D Certificate of Designation.

A copy of the Exchange Agreement is attached hereto as Exhibit 10.1 and is incorporated herein by reference. The foregoing is only a brief description of the material terms of the Exchange Agreement, does not purport to be complete and is qualified in its entirety by reference to the full text of the Exchange Agreement. The representations, warranties and covenants made by the Company in the Exchange Agreement were made solely for the benefit of the parties to the Exchange Agreement, including, in some cases, for the purpose of allocating risk among the parties thereto, and should not be deemed to be a representation, warranty or covenant to investors. Moreover, such representations, warranties or covenants were made as of May 20, 2021. Accordingly, such representations, warranties and covenants should not be relied on as accurately representing the current state of the Company’s affairs

On May 20, 2021 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel LAG-3 related immunotherapy treatments for cancer and autoimmune disease, reported that data from its TACTI-002 and INSIGHT-004 studies have been published in abstracts available via the links below on the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s (ASCO) (Free ASCO Whitepaper) 2021 Annual Meeting’s official website (Press release, Immutep, MAY 20, 2021, View Source [SID1234580430]).

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Poster presentations with new and updated data that are not part of the abstracts will be available on ASCO (Free ASCO Whitepaper).org from 9 am on 4 June 2021 US Eastern time and made available on Immutep’s website at www.immutep.com.

TACTI-002

Title: Results from a phase II study of eftilagimod alpha (soluble LAG-3 protein) and pembrolizumab in patients with PD-L1 unselected metastatic non-small cell lung carcinoma.

Abstract: View Source

Title: Results from a phase II study of eftilagimod alpha (soluble LAG-3 protein) and pembrolizumab in patients with PD-L1 unselected metastatic second- line squamous head and neck carcinoma.
Abstract: View Source

INSIGHT-004

Title: Phase I INSIGHT platform trial: Advanced safety and efficacy data from stratum D evaluating feasibility and safety of eftilagimod alpha (soluble LAG-3 protein) combined with avelumab in advanced solid tumors.
Abstract:  View Source;

About American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Conference
ASCO’s annual meeting represents the world’s largest gathering of oncology physicians, industry representatives, researchers, patient advocates, and investment analysts to discuss cutting-edge clinical research and therapeutics in oncology, and to gain insights for improving cancer care. For additional information on the 2021 ASCO (Free ASCO Whitepaper)’s Annual meeting, please visit View Source

About TACTI-002
TACTI-002 (Two ACTive Immunotherapies) is a Phase II clinical trial being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as "MSD" outside the United States and Canada). The study is evaluating the combination of efti with MSD’s KEYTRUDA (pembrolizumab) in up to 183 patients with second line head and neck squamous cell carcinoma or non-small cell lung cancer in first and second line.

About INSIGHT-004 (also known as INSIGHT Stratum D)
INSIGHT-004 is a Phase I clinical trial and is the fourth arm of the investigator-initiated INSIGHT trial which is being conducted by the Institute of Clinical Cancer Research IKF at Krankenhaus Nordwest in Frankfurt. It is being conducted under Immutep’s collaboration with Merck KGaA and Pfizer Inc., and is evaluating the safety, tolerability and recommended Phase II dose of efti when given in combination with avelumab, a human anti-PD-L1 antibody, in 12 patients with solid cancers. Avelumab is co-developed and co-commercialised by Merck KGaA, Darmstadt, Germany and Pfizer Inc.

On May 20, 2021 Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage biopharmaceutical company developing potential new medicines for patients with pediatric cancers, solid tumors, and other cancers, reported the publication by the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) of three abstracts accepted for poster presentations during the ASCO (Free ASCO Whitepaper) 2021 Annual Meeting (Press release, Salarius Pharmaceuticals, MAY 20, 2021, View Source [SID1234580429]). ASCO (Free ASCO Whitepaper) 2021 will take place June 4-8, 2021 via a virtual platform.

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Salarius submitted three abstracts disclosing clinical research involving its lead drug candidate, seclidemstat. Details on the presentations can be found below. Key findings include data showing that seclidemstat has a manageable safety profile with no significant hematological toxicities, which can be a limitation for other LSD1 inhibitors. In addition, seclidemstat showed proof-of-concept preliminary drug activity in relapsed/refractory Ewing sarcoma and other advanced cancer patients, including FET-rearranged sarcomas, at or below the recommended phase 2 dose (RP2D), which was established to be 900 mg BID.

"We are excited to have the opportunity to present clinical data regarding safety, dosing, and initial efficacy signals for seclidemstat during ASCO (Free ASCO Whitepaper) 2021," said David Arthur, President and Chief Executive of Salarius Pharmaceuticals. "For the first time, we will report full data and the recommended Phase 2 dose from the recently completed dose-escalation stage of our Phase 1/2 clinical trial in Ewing sarcoma. We will also discuss in more detail the preliminary drug activity data observed in FET-rearranged sarcoma patients from our Advanced Solid Tumor (AST) trial that supports our continued development of seclidemstat as single-agent therapy in select sarcomas."

The full abstracts are available on ASCO (Free ASCO Whitepaper)’s 2021 Meeting Library. Details from the Salarius abstracts are as follows:

Abstract #11514: Phase 1 trial of seclidemstat (SP-2577) in patients with relapsed/refractory Ewing sarcoma
Session Type & Title: Poster Discussion Session, Sarcoma
Presenting Author: Damon R. Reed, M.D., H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida.
Date & Time: June 4, 2021, 9 a.m. ET
Key Information & Findings: Seclidemstat has a manageable safety profile with proof-of-concept preliminary activity in heavily pretreated patients with relapsed or refractory Ewing sarcoma.

900 mg BID established as the RP2D
A patient dosed at 600 mg BID achieved a reduction in target lesions after 58 days (cycle 2) with further tumor shrinkage after 112 days (cycle 4) and 168 days (cycle 6) for a maximum 76% tumor shrinkage; Coincident new non-target lesion appearance at end of cycle 2
Two additional patients dosed at 600 mg BID and 900 mg BID had overall stable disease
No treatment-related deaths; The most common (>5%) Grade 3 treatment-related adverse events (TRAEs) were vomiting (15%), abdominal pain (11%), and hypokalemia (11%); One patient with Grade 3 pancreatitis reported elevated lipase, a Grade 4 adverse event (AE); No significant hematological TRAES (Grade 3 occurred in <5% of patients)
Abstract #3073: Preliminary efficacy from an ongoing phase 1 dose escalation study of seclidemstat (SP-2577) in patients (pts) with advanced solid tumors (AST)
Session Type & Title: Poster Session, Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Presenting Author: Sant P. Chawla, M.D., Sarcoma Oncology Research Center, Santa Monica, California
Date & Time: Friday, June 4, 2021, 9 a.m. ET
Key Information & Findings: Seclidemstat has shown activity among advanced sarcoma patients with a manageable safety profile. Dose escalation is ongoing and preliminary clinical data supports further exploration in FET-translocated sarcomas as single agent and in combination therapy. Safety data will be presented after completion of Phase 1 dose-escalation.

As of December 30, 2020, 19 patients were enrolled in AST trial, including patients with prostate ovarian, pancreatic, renal, cervical and breast cancer, as well as sarcomas; Patients received a median of four prior systemic treatments
13 patients were evaluable for response after 58 days of treatment (cycle 2); 7 patients had best response of stable disease (SD) with median time to progression (TTP) of 4.3 months, including 3 patients with advanced FET-rearranged sarcomas
All 7 patients were dosed at 300 mg BID or 600 mg BID
The most common Grade 3 TRAEs were gastrointestinal-related and included diarrhea (5.3%) and abdominal pain (5.3%)
No treatment-related deaths and no Grade 4 TRAEs have been reported
Abstract #TPS11577: Phase 1 expansion trial of the LSD1 inhibitor seclidemstat (SP-2577) with and without topotecan and cyclophosphamide (TC) in patients (pts) with relapsed or refractory Ewing sarcoma (ES) and select sarcomas
Session Type & Title: Poster Session, Sarcoma
Presenting Author: Damon Reed, M.D., H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida.
Date & Time: June 4, 2021, 9 a.m. ET
Key Information: This is an ongoing dose-expansion study assessing seclidemstat at the RP2D (900 mg BID) in two cohorts: a single-agent expansion in select sarcoma patients and a safety lead-in dose escalation and expansion of seclidemstat in combination with topotecan and cyclophosphamide (TC) in Ewing sarcoma patients.

The sarcoma cohort will enroll patients with myxoid liposarcoma or other select sarcomas with FET family translocations, including desmoplastic small round cell tumor (DSRCT); The trial will allow patients treated with one to three prior lines of therapy
The Ewing sarcoma cohort will allow patients treated with up to two prior lines of therapy
Primary objective is safety and tolerability, and secondary objective is efficacy
Recruiting patients across eight U.S. locations
This year, ASCO (Free ASCO Whitepaper) received and reviewed more than 5,400 abstracts for the 2021 Annual Meeting, the world’s largest gathering of physicians, biopharmaceutical companies, researchers, and investors to discuss cancer research and therapeutics. Information about the Annual Meeting may be accessed at View Source