RAPT Therapeutics Announces Pricing of Public Offering of Common Stock

On June 15, 2021 RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage, immunology-based biopharmaceutical company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in oncology and inflammatory diseases, reported the pricing of its previously announced underwritten public offering of 3,787,879 shares of its common stock at a price to the public of $33.00 per share (Press release, RAPT Therapeutics, JUN 15, 2021, https://investors.rapt.com/news-releases/news-release-details/rapt-therapeutics-announces-pricing-public-offering-common-stock [SID1234585135]). All of the shares of common stock are being offered by RAPT. Gross proceeds to RAPT from the offering are expected to be approximately $125 million, before deducting underwriting discounts and commissions and estimated offering expenses. In addition, the underwriters have been granted a 30-day option to purchase up to an additional 568,181 shares of common stock on the same terms and conditions. The offering is expected to close on June 18, 2021, subject to customary closing conditions.

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J.P. Morgan, SVB Leerink and Piper Sandler are acting as joint lead book-running managers for the offering. Cantor is acting as book-running manager for the offering. H.C. Wainwright & Co. and Roth Capital Partners are acting as co-lead managers for the offering.

The offering is being made pursuant to a shelf registration statement, including a base prospectus, filed by RAPT with the Securities and Exchange Commission (SEC), which was declared effective by the SEC on November 16, 2020. The offering may be made only by means of a prospectus supplement and accompanying prospectus. A preliminary prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and are available on the SEC’s website at www.sec.gov. When available, electronic copies of the final prospectus supplement and the accompanying prospectus may also be obtained from: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by email at [email protected] or by telephone at (866) 803-9204; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by email at [email protected] or by telephone at (800) 808-7525, ext. 6105; or Piper Sandler & Co., 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, Attention: Prospectus Department, by email at [email protected] or by telephone at (800) 747-3924.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, 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.

Senti Bio Signs Lease Agreement and Begins Design of Clinical and Commercial-Scale Manufacturing Facility for Allogeneic CAR-NK Cell Therapies

On June 15, 2021 Senti Biosciences, Inc., a leading gene circuit company, reported that it has signed a lease agreement for a property in Alameda, California for the build-out of its wholly-owned cell therapy manufacturing facility (Press release, Senti Biosciences, JUN 15, 2021, View Source [SID1234584384]). Senti Bio is designing the 92,000 square-foot facility to meet current Good Manufacturing Practices (cGMP) with the goal of providing clinical and commercial-scale manufacturing for multiple allogeneic, or "off-the-shelf", chimeric antigen receptor (CAR) natural killer (NK) cell product candidates.

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The facility is being designed to support planned initial clinical trials for Senti Bio’s product candidates, SENTI-202 for acute myeloid leukemia (AML) and SENTI-301 for hepatocellular carcinoma (HCC), which are both preclinical-stage allogeneic CAR-NK cell candidates engineered with gene circuit technologies. Internal manufacturing capabilities are central to Senti Bio’s business strategy of maintaining control over the quality and supply of its present and future candidates for allogeneic CAR-NK cell therapies. The Alameda site was selected to be strategically located near the Company’s headquarters and R&D center in South San Francisco, California.

"We believe that the application of next-generation allogeneic CAR-NK cell therapies has the potential to improve the lives of cancer patients who currently face limited treatment options. Furthermore, if our clinical programs are successful, we believe this facility could support the manufacturing of multiple future product candidates at both clinical and commercial scale," said Philip Lee, PhD, Chief Technology Officer and co-founder of Senti Bio. "Within this facility, we envision bringing together the latest technologies and exceptional manufacturing talent. We look forward to pursuing our goal of creating allogeneic cell therapies that can be manufactured from healthy donor cells in advance of clinical use, and then stored in frozen vials to be delivered rapidly to patients in an off-the-shelf manner."

This manufacturing facility is being designed as a customized end-to-end manufacturing solution to give Senti Bio the ability to isolate NK cells, engineer these cells with proprietary gene circuits, perform cell culture expansion in large batches, and cryopreserve and store the final cGMP products.

About SENTI-202 and SENTI-301

SENTI-202 and SENTI-301 are preclinical product candidates being developed for the potential treatment of AML and HCC, respectively. SENTI-202 is a Logic Gated (OR + NOT) allogeneic CAR-NK cell therapy candidate that is being designed to target and eliminate AML cells while sparing healthy bone marrow cells. SENTI-301 is a Multi-Armed allogeneic CAR-NK cell therapy candidate that is being designed to overcome disease evasion for the treatment of HCC.

Marble Arch Research Publishes Analyst Research Report on Nascent Biotech

On June 15, 2021 Nascent Biotech, Inc. (OTCQB:NBIO) ("Nascent Biotech", "Nascent", or the "Company"), a clinical-stage biotechnology company pioneering the development of monoclonal antibodies targeting treatment of various cancers and viral infections, reported to highlight the publication of an in-depth analyst research report on Nascent Biotech by equity research firm, Marble Arch Research, Inc, which rated NBIO a "Speculative Buy" under its tiered rating system, and specified a price target of between $0.39-$1.99 (Press release, Nascent Biotech, JUN 15, 2021, View Source [SID1234584175]).

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The report concludes, "We believe that there is a reasonable investment thesis at hand to indicate that the company’s market value can rise significantly as its lead development drug, PTB, progresses through its clinical study journey, which has just begun. We rate the stock a Speculative BUY."

‘In its comprehensive report, Marble Arch Research highlights the progress we have made this year as we cross critical milestones on the path toward potential eventual commercialization of our primary platform asset, pritumumab," commented Sean Carrick, CEO of Nascent Biotech. "Now that we are well into clinical trials, we look forward to gaining a deeper understanding of how our research can make the greatest possible positive impact for those suffering from the cancers and viral infections we are targeting. And we continue to seek to protect and reward our shareholders for their loyalty, patience and commitment along the way."

PDS Biotech Prices Public Offering of Common Stock

On June 15, 2021 PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), a clinical-stage immunotherapy company developing novel cancer therapies based on the Company’s proprietary Versamune(R) T-cell activating technology, reported the pricing of its previously announced underwritten public offering of 5,294,118 shares of its common stock at a public offering price of $8.50 per share(Press release, PDS Biotechnology, JUN 15, 2021, View Source [SID1234584097]). The gross proceeds to PDS Biotech, before deducting the underwriting discounts and commissions and estimated offering expenses, are expected to be approximately $45.0 million. All of the shares of common stock to be sold in the offering are being offered by PDS Biotech. PDS Biotech has granted the underwriters a 30-day option to purchase up to an additional 794,117 shares at the public offering price, less underwriting discounts and commissions. The offering is expected to close on or about June 17, 2021, subject to customary closing conditions.

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Cantor Fitzgerald & Co. is acting as sole bookrunner for the offering.

PDS Biotech intends to use a portion of the net proceeds from this offering for the development of our clinical pipeline and for general corporate purposes including working capital.

A shelf registration statement on Form S-3 relating to the public offering of the shares of common stock described above was filed with the Securities and Exchange Commission (the "SEC") and became effective on July 31, 2020. A preliminary prospectus supplement relating to the offering has been filed with the SEC and a final prospectus supplement relating to the offering will be filed with the SEC. Copies of the final prospectus supplement and accompanying prospectus may be obtained from Cantor Fitzgerald & Co., 499 Park Avenue, 4th Floor, New York, NY 10022, Attn: Capital Markets Department, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any 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.

Pivotal Phase 3 SIERRA Trial Data Showing 100% Bone Marrow Transplant Engraftment in Patients Treated with Iomab-B presented at the 2021 Virtual SNMMI Conference

On June 15, 2021 Actinium Pharmaceuticals reported data from its pivotal Phase 3 SIERRA trial for Iomab-B in an oral presentation at the 2021 Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting, which is to be held virtually from June 11th – 14th (Press release, Actinium Pharmaceuticals, JUN 15, 2021, View Source [SID1234584091]). Iomab-B is radiotherapy that targets cells expressing CD45, a protein found only on blood cancer cells and immune cells including bone marrow stem cells, with the radioisotope iodine-131 and is intended to be a targeted conditioning agent to enable potentially curative bone marrow transplant (BMT). The SIERRA trial is the only randomized Phase 3 trial to offer potentially curative BMT as an option for patients with active, relapsed or refractory acute myeloid leukemia (r/r AML) age 55 and above, a patient population not considered eligible for BMT with standard non-targeted conditioning regimens.

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Dr. Mark Berger, Actinium’s Chief Medical Officer, said, "Our enthusiasm for Iomab-B continues to grow at every safety and feasibility update from the pivotal Phase 3 SIERRA trial. With consistently strong engraftment data through 75% of patient enrollment, we believe Iomab-B has the potential to unlock a paradigm shift in the treatment of patients with relapsed and refractory AML. Despite 9 approved drugs for patients with AML since 2017, many of which are targeted agents, AML remains one of the most difficult to treat blood cancers with the lowest 5-year survival rate. In developing Iomab-B our goal is to improve patient outcomes by enabling potentially curative BMT for a large portion of the AML patient population."

SNMMI Presentation Title: Relationship of Marrow Radiation Dose and Timing of Engraftment for Targeted Radioimmunotherapy with Anti-CD45 Iodine (131I) Apamistamab [Iomab-B] in Patients with Active Relapsed or Refractory Acute Myeloid Leukemia

Presenter: Susan Passalaqua, MD, Banner MD Anderson Cancer Center

SNMMI Presentation Highlights:

100% BMT and engraftment rate for patients receiving a therapeutic dose of Iomab-B compared to 18% of patients receiving physician’s choice of salvage therapy on the control arm
79% of all patients enrolled on SIERRA were able to proceed to BMT despite being a patient population not considered eligible for BMT with standard approaches
Iomab-B delivers high amounts of targeted radiation to the bone marrow with minimal impact on other organs resulting in lower rates and severity of adverse events

About Iomab-B
Iomab-B (I-131 apamistamab) is an Antibody Radiation Conjugate (ARC) that is intended to condition or prepare patients for a potentially curative bone marrow transplant (BMT) in a targeted manner with the goal of reducing adverse events and increasing patent access to BMT. Via the monoclonal antibody apamistamab, Iomab-B targets CD45, an antigen widely expressed on leukemia and lymphoma cancer cells, immune cells and stem cells. Apamistamab is linked to the radioisotope iodine-131 (I-131) and once its attached to its target cells, it emits energy that travels about 100 cell lengths, destroying a patient’s cancer cells and ablating their bone marrow. By carrying iodine-131 directly to the bone marrow in a targeted manner, Actinium believes Iomab-B can avoid the side effects of radiation on most healthy tissues while effectively killing the patient’s cancer and marrow cells.

Iomab-B is currently being studied in the pivotal Phase 3 SIERRA (Study of Iomab-B in Relapsed or Refractory AML) trial, a 150-patient, randomized controlled clinical trial in patients with relapsed or refractory Acute Myeloid Leukemia (AML) who are age 55 and above. The SIERRA trial is being conducted at preeminent transplant centers in the U.S. with the primary endpoint of durable Complete Remission (dCR) at six months and a secondary endpoint of overall survival. Upon approval, Iomab-B is intended to prepare and condition patients for a bone marrow transplant, also referred to as a hematopoietic stem cell transplant, in a potentially safer and more efficacious manner than the non-targeted intensive chemotherapy conditioning that is the current standard of care in bone marrow transplant conditioning. A bone marrow transplant is often considered the only potential cure for patients with certain blood-borne cancers and blood disorders. Additional information on the Company’s Phase 3 clinical trial in R/R can be found at www.sierratrial.com.