On February 3, 2021 Sana Biotechnology, Inc. (Sana) (Nasdaq: SANA), a company focused on creating and delivering engineered cells as medicines, reported the pricing of its upsized initial public offering of 23,500,000 shares of its common stock at a public offering price of $25.00 per share (Press release, Sana Biotechnology, FEB 3, 2021, View Source [SID1234574702]). All of the shares of common stock are being offered by Sana. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Sana, are expected to be $587.5 million. Sana’s common stock is expected to begin trading on The Nasdaq Global Select Market on February 4, 2021, under the ticker symbol "SANA." The offering is expected to close on February 8, 2021, subject to the satisfaction of customary closing conditions. In addition, Sana has granted the underwriters a 30-day option to purchase up to an additional 3,525,000 shares of common stock at the initial public offering price, less the underwriting discounts and commissions, and, if exercised in full, would result in aggregate gross proceeds of approximately $675.6 million.

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Morgan Stanley, Goldman Sachs & Co. LLC, J.P. Morgan and BofA Securities are acting as joint book-running managers for the offering.

Registration statements relating to the shares being sold in this offering were filed with the Securities and Exchange Commission and became effective on February 3, 2021. The offering is being made only by means of a prospectus, copies of which may be obtained, when available, from: Morgan Stanley, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014, or by email at [email protected]; Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, by telephone at (866) 471-2526, or by email at [email protected]; J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by email at [email protected], or by telephone at (866) 803-9204; or BofA Securities, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001, Attention: Prospectus 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 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.

On February 3, 2021 Sensei Biotherapeutics, Inc., a clinical-stage immunotherapy company focused on the discovery and development of next generation therapeutics for cancer, reported the pricing of its upsized initial public offering of 7,000,052 shares of common stock at a public offering price of $19.00 per share (Press release, Sensei Biotherapeutics, FEB 3, 2021, View Source [SID1234574674]). The gross proceeds to Sensei from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Sensei, are expected to be approximately $133.0 million. All of the shares are being offered by Sensei and are expected to begin trading on The Nasdaq Global Market on February 4, 2021 under the ticker symbol "SNSE." In addition, Sensei has granted the underwriters a 30-day option to purchase up to an additional 1,050,007 shares of common stock at the initial public offering price, less underwriting discounts and commissions. The offering is expected to close on February 8, 2021 subject to the satisfaction of customary closing conditions.

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Citigroup, Piper Sandler & Co. and Berenberg are acting as joint book-running managers for the offering. Oppenheimer & Co. is acting as the lead manager for the proposed offering. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

A registration statement relating to the securities was declared effective by the Securities and Exchange Commission on February 3, 2021. The offering of these securities is being made only by means of a prospectus. A copy of the final prospectus, when available, may be obtained from Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at 800-831-9146 or by email at [email protected]; Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, or by telephone at 800-747-3924 or by email at [email protected]; or Berenberg Capital Markets LLC, Attention: Investment Banking, 1251 Avenue of the Americas, 53rd Floor, New York, NY 10020, or by telephone at 646-949-9000 or by email at [email protected].

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 February 3, 2021 Kaleido Biosciences, Inc. (Nasdaq: KLDO), a clinical-stage healthcare company with a differentiated, chemistry-driven approach to targeting the microbiome to treat disease and improve human health, reported the pricing of an underwritten public offering of 5,250,000 shares of its common stock at a public offering price of $11.50 per share (Press release, Kaleido Biosciences, FEB 3, 2021, View Source [SID1234574594]). In addition, Kaleido has granted the underwriters a 30-day option to purchase up to an additional 787,500 shares of its common stock at the public offering price, less underwriting discounts and commissions. The gross proceeds to Kaleido from this offering are expected to be approximately $60.4 million, before deducting underwriting discounts and commissions and other estimated offering expenses and excluding any exercise of the underwriters’ option to purchase additional shares. All of the shares are being offered by Kaleido. The offering is expected to close on February 8, 2021, subject to customary closing conditions.

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Morgan Stanley and Piper Sandler are acting as joint book-running managers for the offering. Canaccord Genuity is acting as lead manager for the offering.

Kaleido intends to use the net proceeds from the offering, in addition to its existing cash resources, to fund its continued research and development activities, including the completion of the ongoing clinical studies of KB109 in patients with mild-to-moderate COVID-19 and the ongoing clinical study of KB295 in patients with mild-to-moderate ulcerative colitis; to conduct additional studies or initiate preparation for commercialization of KB109 if current studies in patients with mild-to-moderate COVID-19 are successful; to generate additional data and/or begin clinical studies in other areas such as immuno-oncology, cardiometabolic and liver diseases and diseases associated with pathogens; to fund any other research and development activities that relate to its current and future clinical and preclinical activities; and the remainder for planned general and administrative expenses, working capital and other general corporate purposes.

The securities described above were offered by Kaleido pursuant to a shelf registration statement on Form S-3 (No. 333-240323) that was declared effective by the Securities and Exchange Commission (SEC) on August 14, 2020. A final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website located at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained, when available, by contacting: Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014 and Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, or by telephone at 800-747-3924, or by email at [email protected].

This press release does 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 registration or qualification under the securities laws of that state or jurisdiction.

On February 3, 2021 PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company’s proprietary Versamune T-cell activating technology, reported that the National Cancer Institute’s (NCI) Phase 2 clinical study of PDS0101 for the treatment of advanced human papillomavirus (HPV)-associated cancers that have progressed or returned after treatment achieved its preliminary objective response (Press release, PDS Biotechnology, FEB 3, 2021, View Source [SID1234574593]). The trial, which studies PDS0101 in combination with two investigational immune-modulating agents bintrafusp alfa (M7824), a TGF-β "trap"/ anti-PD-L1 bifunctional fusion protein, and NHS-IL12 (M9241), a DNA-targeted immunocytokine, will now progress to full enrollment of approximately 20 in this group of checkpoint inhibitor (CPI) naïve patients. As a result of achieving this milestone, preliminary efficacy assessment of the triple combination in an added group of approximately 20 patients who have failed prior therapy with checkpoint inhibitors (CPI refractory) is ongoing.

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The NCI Center for Cancer Research’s Laboratory of Tumor Immunology and Biology (LTIB) and Genitourinary Malignancies Branch (GMB) are jointly leading this Phase 2 trial. The trial is evaluating the treatment combination in two patient groups: one in patients who failed prior treatment, but are naïve to checkpoint inhibitor treatment; and the second in patients who have failed treatment with checkpoint inhibitors. As prespecified in the clinical trial design, the achievement of an objective response as measured by radiographic tumor responses according to RECIST 1.1 or iRECIST among at least three of the first eight patients allows the trial to progress to full enrollment.

Pooled data from phase 1 and 2 trials reported in the October 2020 issue of the Journal for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (J ImmunoTher Cancer 2020;8:e001395. doi:10.1136/jitc-2020-001395) showed that bintrafusp alfa (M7824) a first-in-class bifunctional fusion protein composed of the extracellular domain of human TGF-β (TGF-β "trap") fused to an IgG1 antibody blocking PD-L1 (anti–PD-L1) protein, demonstrated efficacy in checkpoint inhibitor-naïve patients with HPV-associated malignancies. The observed response rate was 30.5%. M9241 is an immunocytokine composed of 2 heterodimers of IL-12 fused to the heavy chains of a human antibody targeting DNA released from necrotic tumor cells. In preclinical studies performed at the NCI comparing each drug alone versus all three agents used in combination, the triple combination achieved the highest induction of tumor-specific CD8+ killer T-cells and superior antitumor effect (J ImmunoTher Cancer 2020;8:e000612. doi:10.1136/jitc-2020-000612).

"The achievement of this important milestone in this NCI-led Phase 2 clinical trial strengthens the evidence of our novel Versamune platform’s potential ability to induce high levels of tumor-specific CD8+ killer T-cells that attack the cancer to achieve tumor regression," commented Dr. Lauren Wood, Chief Medical Officer of PDS Biotech. "The initial data solidifies our belief that PDS0101’s demonstrated preclinical efficacy when combined with these two immune-modulating agents, has the potential to significantly improve clinical outcomes for patients with advanced and currently untreatable HPV-associated cancers."

The studies are being performed as part of a Cooperative Research and Development Agreement (CRADA) between PDS Biotech and the NCI. Dr. Jeffrey Schlom, Chief, LTIB, and Dr. James Gulley, Chief, GMB, at NCI are serving as principal investigators for the NCI, while Dr. Frank Bedu-Addo and Dr. Lauren Wood, PDS Biotech’s Chief Executive Officer and Chief Medical Officer respectively, are serving as PDS Biotech’s investigators.

Dr. Julius Strauss, Staff Clinician, LTIB, is serving as the Principal Investigator of this phase 2 clinical trial in advanced HPV-associated cancers. For patients interested in enrolling in this clinical study, please call NCI’s toll-free number 1-800-4-CANCER (1-800-422-6237), email [email protected], or visit the website: View Source

On February 3, 2021 OPKO Health, Inc. (NASDAQ: OPK) reported operating and financial results for the three months ended December 31, 2020, as well as discuss financial guidance, after the close of the U.S. financial markets on Thursday, February 18, 2021 (Press release, Opko Health, FEB 3, 2021, View Source [SID1234574592]). OPKO’s senior management will provide a business update and discuss results in greater detail during a conference call and live audio webcast on February 18th beginning at 4:30 p.m. Eastern time.

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CONFERENCE CALL & WEBCAST INFORMATION

OPKO encourages participants to pre-register for the conference call using the link here or dialing (888) 869-1189 or (706) 643-5902 and using conference ID 8597848. Upon registering, participants will receive dial-in numbers, an event passcode and a unique registrant ID to gain immediate access to the call and bypass the live operator. Participants may pre-register at any time, including up to and after the start of the call.

To access the live call via webcast, please click on the link OPKO 4Q20 Results Conference Call. Individual investors and investment community professionals who do not plan to ask a question during the call’s Q&A session are encouraged to listen to the call via the webcast.

For those unable to listen to the live conference call, a replay can be accessed for a period of time on OPKO’s website at OPKO 4Q20 Results Conference Call. A telephone replay will be available beginning approximately two hours after the close of the conference call. To access the replay, please dial (855) 859-2056 or (404) 537-3406, and use conference ID 8597848.