On December 15, 2020 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing novel, targeted and personalized therapies for rare and difficult to treat cancers, reported completion of the sixth dosing cohort in the ReSPECT Phase 1 clinical trial evaluating the Company’s lead investigational asset, Rhenium NanoLiposome (RNL), in patients with recurrent glioblastoma (GBM) (Press release, Cytori Therapeutics, DEC 15, 2020, View Source [SID1234572872]).

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The sixth cohort of the ReSPECT trial included an increase in both the RNL drug volume and the radiation dose to 8.8 milliliters and 22.3 millicuries, respectively. RNL is designed to safely, effectively and conveniently deliver a very high dose of radiation potentially up to 15 times greater than traditional external beam radiation therapy.

Eighteen patients with recurrent GBM thus far have been treated in the ReSPECT trial. This trial is supported by the U.S. National Institutes of Health/National Cancer Institute at three trial sites in the U.S., including UT Health Science Center San Antonio and UT Southwestern Medical Center.

"The dose escalation design in ReSPECT permits both increases in drug volume and the radiation dose of RNL," said Marc Hedrick, M.D., President and Chief Executive Officer of Plus Therapeutics. "This scheme is important as it allows us to potentially better target those malignant cells at the tumor margin that may be the source of future disease progression."

As previously disclosed, the U.S. Food and Drug Administration has granted both Orphan Drug designation and Fast Track designation to RNL for the treatment of patients with GBM. Additional details about the ReSPECT trial are available at clinicaltrials.gov (NCT01906385). Interim data from ReSPECT was disclosed in November 2020 at the Society of Neuro-Oncology Annual Meeting and showed that RNL was well-tolerated, with no dose-limiting toxicity observed in the first 15 patients enrolled in the trial.

On December 15, 2020 Scopus BioPharma Inc. (Nasdaq: SCPS) reported the pricing of its initial public offering (Press release, Scopus BioPharma, DEC 15, 2020, View Source(Nasdaq%3A%20SCPS)%20today%20announced,price%20of%20%245.50%20per%20share [SID1234572871]).

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The company’s common stock is set to begin trading Wednesday, December 16, 2020 on the Nasdaq Global Market under the ticker symbol "SCPS".

The company is offering 500,000 shares of common stock at a public offering price of $5.50 per share.

The Benchmark Company, LLC acted as Sole Bookrunning Manager and Joseph Gunnar & Co., LLC acted as Co-Manager for the offering.

Greenberg Traurig, LLP is acting as counsel to the company. Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. is acting as counsel to the underwriters.

An offering statement relating to the shares of common stock was filed with the U.S. Securities and Exchange Commission and became qualified on December 14, 2020. The offering is being made only by means of an offering circular, copies of which may be obtained, when available, by contacting: The Benchmark Company, LLC, Attention: Prospectus Department, 150 E. 58th Street, 17th Floor, New York, NY 10155, by calling (212) 312-6700 or by e-mail at [email protected]; or Joseph Gunnar & Co., LLC, Attention: Prospectus Department, 30 Broad Street, 11th Floor, New York, NY 10004, by calling (212) 440-9600 or by email at [email protected]. The offering circular is also available on the U.S. Securities and Exchange Commission website at www.sec.gov.

Scopus BioPharma intends to use the proceeds of the offering principally to further development of the company’s lead drug candidate, a novel, targeted immuno-oncology gene therapy for the treatment of multiple cancers.

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 of these securities under the securities laws of any such state or jurisdiction.

On December 15, 2020 Genmab A/S (Nasdaq: GMAB) reported that at a board meeting the board decided to grant 9,663 restricted stock units to members of the board of directors and employees of the company as well as the company’s subsidiaries and 24,964 warrants to employees of the company and the company’s subsidiaries (Press release, Genmab, DEC 15, 2020, View Source [SID1234572870]).

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Each restricted stock unit is awarded cost-free and provides the owner with a right and obligation to receive one share in Genmab A/S of nominally DKK 1. The vesting of the restricted stock units granted to members of the board of directors will be subject to additional vesting criteria in the event of a change of control. The fair value of each restricted stock unit is equal to the closing market price on the date of grant of one Genmab A/S share, DKK 2,381.

The restricted stock units will vest on the first banking day of the month following a period of three years from the date of grant. Furthermore, the restricted stock units are subject to vesting conditions set out in the restricted stock unit program adopted by the board of directors in accordance with the Remuneration Policy adopted by the shareholders at the annual general meeting. Information concerning Genmab’s restricted stock unit program can be found on www.genmab.com under Investors > Stock information > Restricted stock units.

The exercise price for each warrant is DKK 2,381. Each warrant is awarded cost-free and entitles the owner to subscribe one share of nominally DKK 1 subject to payment of the exercise price. By application of the Black-Scholes formula, the fair value of each warrant can be calculated as DKK 754.05.

The warrants vest three years after the grant date, and all warrants expire at the seventh anniversary of the grant date. The new warrants have been granted on the terms and conditions set out in the warrant program adopted by the board of directors on March 28, 2017. Information concerning Genmab’s warrant schemes can be found on www.genmab.com under Investors > Stock information > Warrants.

On Tuesday December 15, 2020 Forma Therapeutics Holdings, Inc. (Nasdaq: FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, reported the closing of an underwritten public offering of 6,095,000 shares of its common stock, including the exercise in full by the underwriters of their option to purchase up to an additional 795,000 shares of common stock, at a public offering price of $45.25 per share (Press release, Forma Therapeutics, DEC 15, 2020, View Source [SID1234572869]). The aggregate gross proceeds from the offering, before deducting underwriting discounts and commissions and offering expenses, were approximately $275.8 million. All of the shares in the offering were offered by Forma.

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Jefferies, SVB Leerink and Credit Suisse acted as joint book-running managers for the offering. Oppenheimer & Co acted as lead manager for the offering.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any offer or sale of these securities in any state or other 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 other jurisdiction.

Registration statements relating to these securities became effective on December 10, 2020. The offering was made only by means of a prospectus, copies of which may be obtained from: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected]; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6132, or by email at [email protected]; Credit Suisse Securities (USA) LLC, Attention: Prospectus Department, 6933 Louis Stephens Drive, Morrisville, NC 27560, by telephone at (800) 221-1037, or by email at [email protected]; or Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, NY, 10004, by telephone at (212) 667-8055, or by email at [email protected].

On December 15, 2020 Lantern Pharma (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("A.I.") platform to transform drug discovery and development, and identify patients who will benefit from its portfolio of targeted oncology therapeutics, reported new scientific data that substantiates blood brain barrier permeability (BBB) for its drug candidate LP-184 (Press release, Lantern Pharma, DEC 15, 2020, View Source;utm_medium=rss&utm_campaign=lantern-pharma-announces-scientific-preclinical-data [SID1234572868]). LP-184 is being targeted for treating Glioblastoma Multiforme (GBM), an aggressive malignant form of brain cancer that comprises about 52% of all primary malignant brain tumors according to the American Association of Neurological Surgeons. GBM has a median survival rate of only 15 months and ranks among the most aggressive of human cancers. It is considered an orphan disease for which there is no cure. The global GBM treatment market is projected to reach $3.3 billion by 2024, according to GlobalData, with the U.S. representing the largest market.

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The ability of a drug candidate to cross the blood brain barrier is of critical importance in treatment outcomes for CNS and brain cancers. Many drugs fail in clinical trials because of their low blood brain barrier permeability. Lantern’s A.I. engine along with algorithms tuned to predict BBB permeability played an important role in helping determine which CNS cancers and which genomically-defined subtypes of CNS cancer should be prioritized for development.

The current standard of care for GBM consists of de-bulking surgery followed by combined treatments with fractionated ionizing radiation (IR) and the DNA alkylating agent temozolomide (TMZ). The effectiveness of standard therapy with TMZ is limited because the response of GBM to TMZ is dependent upon the expression of the DNA repair enzymatic protein, O6-alkylguanine DNA alkyltransferase (MGMT). Over the period of treatment, tumors can evolve and begin to overexpress MGMT and therefore become largely resistant to TMZ. At the stage of GBM relapse and recurrence, no effective therapy strategies currently exist. LP-184 has a different mechanism of action relative to TMZ and has not demonstrated limitations due to MGMT levels, the enzymatic protein associated with resistance to TMZ in GBM and gliomas.

LP-184 works by causing DNA damage in cancer cells via the nucleotide excision repair (NER) pathway, while TMZ causes damage via the base excision repair pathway (BER). These approaches may be complementary and represents potential for future therapeutic applications. Using in-silico tools, and also generating further in-vitro data from both neuronal cell-plates, and neurospheres, LP-184 demonstrated permeability that was in line with TMZ and other therapies being used in GBM today, while also demonstrating nano-molar potency.

Panna Sharma, CEO of Lantern Pharma, stated: "This data is extremely significant as it provides evidence that opens up a range of brain cancers with high clinical need that we should pursue, and also provides evidence that our RADR platform is working as was designed. Our mission is to transform and accelerate the cancer drug development process. If we can compress the time to clinical trials, and de-risk LP-184, we can save years of research and millions of dollars in developing treatments for GBM and potentially other CNS and brain cancers."

Mr. Sharma continued, "As part of our development strategy we will be providing updates on new collaborations and research studies with leading research and translational cancer centers to help us further validate our findings and guide the ideal clinical usage of the compound in GBM. Based on data from our RADR platform, the blood brain barrier profile validation, and information on the genomics that seem to drive response to LP-184 we are now targeting a broader range of central nervous system cancers, including cancers that metastasize to the brain, and pediatric brain tumors."