On July 16, 2021 CytRx Corporation (OTCQB: CYTR) ("CytRx" or the "Company"), a specialized biopharmaceutical company focused on research and development for the oncology and neurodegenerative disease categories, reported the closing of its previously announced sale of its securities pursuant to a securities purchase agreement (the "Purchase Agreement") to a single healthcare-focused institutional investor (the "Investor") for aggregate gross proceeds of approximately $10 million (Press release, CytRx, JUL 16, 2021, View Source [SID1234584911]). The Investor is independent of the Company’s Board of Directors and management team. The Company intends to use the net proceeds of the offering for working capital purposes.

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Under the terms of the Purchase Agreement, CytRx sold 2,000,000 shares of its common stock at a purchase price of $0.88 per share for total gross proceeds of approximately $1.76 million in a registered direct offering and 8,240 shares of Series C 10.00% Convertible Preferred Stock (the "Preferred Stock") at a purchase price of $1,000 per share for total gross proceeds of approximately $8.24 million, in a concurrent private placement. The shares of the Preferred Stock are convertible, upon shareholder approval as described below, into an aggregate of up to 9,363,637 shares of common stock at a conversion price of $0.88 per share. The Preferred Stock includes beneficial ownership limitations that preclude conversion that would result in the Investor owning in excess of 9.99% of the Company’s outstanding shares of common stock.

CytRx also issued to the Investor an unregistered preferred investment option (the "Investment Option") that allows for the purchase of up to 11,363,637 shares of common stock for additional gross proceeds of approximately $10 million if the Investment Option is exercised in full. The exercise price for the Investment Option is $0.88 per share. The Investment Option has a term equal to five and one-half years commencing upon the Company increasing its authorized common stock following shareholder approval (the "Authorized Share Increase").

H.C. Wainwright & Co. acted as exclusive placement agent for the offering.

As described above, the issuance of the shares of common stock underlying the Preferred Stock and the Investment Option sold in the private placement is subject to the Authorized Share Increase. Pursuant to the Purchase Agreement, the Company must hold a meeting of its stockholders no later than September 25, 2021 to seek shareholder approval.

The shares of common stock sold in the registered direct offering were offered and sold in the registered direct offering by CytRx pursuant to a "shelf" registration statement on Form S-3 (File No. 333-255431), including a base prospectus, previously filed with, and declared effective by the Securities and Exchange Commission (the "SEC") on July 12, 2021. The registered direct offering was made only by means of a prospectus supplement that forms a part of the registration statement. A final prospectus supplement and an accompanying base prospectus relating to the registered direct offering has been filed with the SEC and is available on the SEC’s website located at View Source Electronic copies of the prospectus supplement and accompanying base prospectus may be obtained from H.C. Wainwright & Co., 430 Park Avenue, New York, NY 10022 or via telephone at (212) 856-5711 or email at [email protected].

The Series C Preferred Stock and Investment Options sold in the private placement and the shares of common stock issuable thereunder were offered pursuant to an applicable exemption from the registration requirements of the Securities Act of 1933, as amended (the "Act"), and have not been registered under the Act, or applicable state securities laws, and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements.

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 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 July 16, 2021  Aptevo Therapeutics Inc. ("Aptevo") (NASDAQ:APVO), a clinical-stage biotechnology company focused on developing novel immuno-oncology therapeutics based on its proprietary ADAPTIR and ADAPTIR-FLEX platform technologies, reported that Dr. Jane Gross, Senior Vice President of Research and Development and Chief Scientific Officer of Aptevo, will give a presentation and participate in a live interactive panel discussion at the Cambridge Health Institute PEGS Virtual Conference being hosted from Monday, July 19, 2021 – Thursday, July 22, 2021 (Press release, Aptevo Therapeutics, JUL 16, 2021, View Source [SID1234584910]).

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Dr. Gross’ talk, entitled "Generating Immuno-Modulatory Bispecific Therapeutic Candidates for the Treatment of Hematologic and Solid Tumors," will occur on Monday, July 19, 2021 at 11:25 am Eastern time. This presentation will focus on those aspects that are unique to the Aptevo ADAPTIR and ADAPTIR-FLEX platforms and enable the generation of bispecific and multi-specific therapeutic candidates with anti-cancer potential.

The live, interactive panel session, to include Dr. Gross and entitled "Bispecifics vs CAR T Therapy for T Cell Engagement: Competing or Complementary?" will occur on Monday, July 19, 2021 at noon Eastern time. The panel discussion will focus on the benefits of bispecific antibodies vs. CAR T therapies and the potential role of either or both treatment modalities for the treatment of cancers.

"We are excited about Jane’s participation in the upcoming PEGS conference because it provides an important platform from which we can share the accomplishments and potential of our ADAPTIR and ADAPTIR-FLEX technologies," said Marvin White, President and CEO of Aptevo. "There is a growing body of evidence that tells us the fight against cancer will require many kinds of therapies that are both cancer specific and patient specific. Robust discussion around these needs, and the relative benefits and challenges associated with them, is critical to our collective success."

On July 16, 2021 MorphoSys reported a US$ 100 Million Capital Increase to Implement the Purchase of 1,337,552 shares by Royalty Pharma (Press release, MorphoSys, JUL 16, 2021, View Source [SID1234584909])

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MorphoSys AG (FSE: MOR; NASDAQ: MOR) ("MorphoSys") reported that its Management Board, with the approval of the Supervisory Board, has passed a resolution to increase the share capital of MorphoSys AG by issuing 1,337,552 new ordinary shares from the Authorized Capital 2021-II, excluding pre-emptive rights of existing shareholders, to implement the purchase of 1,337,552 new ordinary shares by Royalty Pharma Investments 2019 ICAV, a subsidiary of Royalty Pharma plc (NASDAQ: RPRX) ("Royalty Pharma"). The new ordinary shares represent 3.9% of the registered share capital of MorphoSys following the capital increase.

"We’re pleased that Royalty Pharma is taking an equity position in MorphoSys as part of the long-term strategic finance partnership the two companies entered into this year," said Sung Lee, Chief Financial Officer of MorphoSys.

Royalty Pharma’s share purchase in the aggregate amount of US$ 100 million is part of the funding agreement with MorphoSys for the now completed acquisition of Constellation Pharmaceuticals; the agreement has become effective upon the completion of the merger on 15 July 2021. Royalty Pharma has purchased the 1,337,552 new ordinary shares at a price of € 63.35 per share, the volume-weighted average price of MorphoSys shares five trading days on the Frankfurt Stock Exchange (Xetra) prior to the merger, representing a premium of 12.1% to today’s closing market price on the Frankfurt Stock Exchange (Xetra). The new MorphoSys shares will be listed on the Frankfurt Stock Exchange. Royalty Pharma has agreed, subject to limited exceptions, not to sell or otherwise transfer any of the new ordinary shares for a period of twelve months.

On July 16, 2021 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported that financial results for the three and six months ended June 30, 2021 after the close of the U.S. financial markets on Thursday, July 29, 2021 and will hold a conference call that same day beginning at 4:30 p.m. Eastern time (Press release, Ligand, JUL 16, 2021, View Source [SID1234584908]). Speakers on the call will include Ligand’s CEO John Higgins, President and COO Matt Foehr and Executive Vice President and CFO Matt Korenberg .

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On July 16, 2021 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM: HCM; HKEX: 13) reported the European Medicines Agency ("EMA") has validated and accepted its marketing authorization application ("MAA") for surufatinib for the treatment of pancreatic and extra-pancreatic (non-pancreatic) neuroendocrine tumors ("NETs") (Press release, Hutchison China MediTech, JUL 16, 2021, View Source [SID1234584907]). The EMA’s validation confirms that the submission is sufficiently complete and that it is ready to commence the formal review process.

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The submission follows scientific advice from the EMA’s Committee for Medicinal Products for Human Use ("CHMP"), from which it was concluded that the two positive Phase III studies of surufatinib in patients with pancreatic and extra-pancreatic NET in China (SANET-p1 and SANET-ep2, both previously reported in The Lancet Oncology), along with existing data from surufatinib in U.S. extra-pancreatic and pancreatic NET patients, could form the basis to support a MAA. The submission follows the acceptance of a new drug application ("NDA") with the U.S. Food and Drug Administration ("FDA"), as announced on July 1, 2021.

Dr. Marek Kania, Managing Director and Chief Medical Officer of HUTCHMED International Corporation, said, "HUTCHMED’s novel oncology pipeline is making important progress globally and the EMA’s validation of surufatinib’s MAA, which we believe recognizes the scientific value of this submission package, follows the recent acceptance of the U.S. NDA by the FDA. With its launch earlier this year in China, surufatinib has given NET patients an important new therapeutic option and we now hope to soon be able to bring this important treatment to patients across the U.S. and Europe."

About NETs

NETs form in cells that interact with the nervous system or in glands that produce hormones. They can originate in various parts of the body, most often in the gut or the lungs and can be benign or malignant. NETs are typically classified as pancreatic NET ("pNET") or extra-pancreatic (non-pancreatic) NET ("epNET").

According to Frost & Sullivan, there were 19,000 newly diagnosed cases of NET in the U.S. in 2020. Rates across the European Union (E.U.) appear largely similar to the U.S.. This is supported by an analysis of global epidemiologic trends, which also show growth in the incidence of NETs worldwide.3 Importantly, NETs are associated with a relatively long duration of survival compared to other tumors. As a result, there were approximately 140,000 estimated patients living with NET in France, Germany, Italy, Spain, and the United Kingdom in 2020.4

About Surufatinib

Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with vascular endothelial growth factor receptors (VEGFR) and fibroblast growth factor receptor (FGFR), which both inhibit angiogenesis, and colony stimulating factor-1 receptor (CSF-1R), which regulates tumor-associated macrophages, promoting the body’s immune response against tumor cells. Its unique dual mechanism of action may be very suitable for possible combinations with other immunotherapies, where there may be synergistic anti-tumor effects.

HUTCHMED currently retains all rights to surufatinib worldwide.

About Surufatinib Development

NETs in the U.S. and Europe: A U.S. FDA NDA submission was accepted in June 2021, followed by a MAA submission to the EMA in Europe validated in July 2021. The basis to support these filings includes the completed SANET-ep and SANET-p studies, along with existing data from surufatinib in U.S. epNET and pNET patients (clinicaltrials.gov identifier: NCT02549937). In the U.S., surufatinib was granted Fast Track Designations for development in pNET and epNET in April 2020, and Orphan Drug Designation for pNET in November 2019.

epNETs in China: On December 30, 2020, surufatinib was granted drug registration approval by the National Medical Products Administration of China ("NMPA") for the treatment of epNET. Surufatinib is marketed in China under the brand name Sulanda. The approval was based on results from the SANET-ep study, a Phase III trial (clinicaltrials.gov identifier: NCT02588170) in patients with advanced epNETs conducted in China. The study met the pre-defined primary endpoint of progression-free survival ("PFS") at a preplanned interim analysis. The positive results of this trial were highlighted in an oral presentation at the 2019 ESMO (Free ESMO Whitepaper) Congress and published in The Lancet Oncology in September 2020.5 Median PFS was significantly longer for patients treated with surufatinib at 9.2 months, compared to 3.8 months for patients in the placebo group (HR 0.334; 95% CI: 0.223-0.499; p<0.0001). Surufatinib had an acceptable safety profile, with the most common treatment-related adverse events of grade 3 or worse being hypertension (36% of surufatinib patients vs. 13% of placebo patients), proteinuria (19% vs. 0%) and anemia (5% vs. 3%).

pNETs in China: On June 18, 2021, surufatinib was granted drug registration approval by the NMPA for the treatment of pNET. The approval was based on results from the SANET-p study, a Phase III trial (clinicaltrials.gov identifier: NCT02589821) in patients with advanced pNET in China. The pre-defined primary endpoint of PFS was met at a preplanned interim analysis, leading to a second NDA accepted by the NMPA in September 2020. The positive results of this study were presented at the 2020 ESMO (Free ESMO Whitepaper) Virtual Congress and published simultaneously in The Lancet Oncology6, demonstrating that surufatinib reduces the risk of disease progression or death by 51% in patients, with a median PFS of 10.9 months compared to 3.7 months on placebo (HR 0.491; 95% CI: 0.391-0.755; p=0.0011). The safety profile of surufatinib was manageable and consistent with observations in prior studies.

Biliary tract cancer in China: In March 2019, HUTCHMED initiated a Phase IIb/III study comparing surufatinib with capecitabine in patients with advanced biliary tract cancer whose disease progressed on first-line chemotherapy. The primary endpoint is overall survival (OS) (clinicaltrials.gov identifier: NCT03873532).

Immunotherapy combinations: HUTCHMED entered into collaboration agreements to evaluate the safety, tolerability and efficacy of surufatinib in combination with anti-PD-1 monoclonal antibodies, including with tislelizumab (BGB-A317), Tuoyi (toripalimab) and Tyvyt (sintilimab), which are approved as monotherapies in China.