On June 14, 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 that it has commenced an underwritten public offering of $125 million of its common stock (Press release, RAPT Therapeutics, JUN 14, 2021, https://investors.rapt.com/news-releases/news-release-details/rapt-therapeutics-announces-proposed-public-offering-common [SID1234585134]). In addition, RAPT expects the underwriters to be granted a 30-day option to purchase up to an additional $18.75 million of its common stock on the same terms and conditions. All of the shares of common stock are being offered by RAPT. The proposed offering is subject to market conditions, and there can be no assurance as to whether or when the proposed offering may be completed or as to the actual size or terms of the proposed offering.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

J.P. Morgan, SVB Leerink and Piper Sandler are acting as joint lead book-running managers for the proposed offering. Cantor is acting as book-running manager for the proposed 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 will be filed with the SEC and will be available on the SEC’s website located at www.sec.gov. When available, electronic copies of the preliminary 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.

On June 14, 2021 Vaccitech plc (NASDAQ: VACC), a clinical-stage biopharmaceutical company engaged in the discovery and development of novel immunotherapeutics and vaccines for the treatment and prevention of infectious diseases and cancer, reported financial results for the quarter ended March 31, 2021, and provided an overview of the Company’s recent corporate developments (Press release, Vaccitech, JUN 14, 2021, View Source [SID1234584933]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The first quarter of 2021 was transformational for Vaccitech as we closed a Series B financing round and initiated patient dosing in our two lead therapeutic programs, HBV and HPV," said Bill Enright, CEO of Vaccitech. "We drove on to successfully complete our IPO early in the second quarter and are now capitalized to advance multiple pipeline candidates into Phase 3 trials."

First Quarter and Recent Corporate Developments

Closed an initial public offering of American Depository Shares for total gross proceeds of $110.5 million
Initiated patient dosing in HPV001, a Phase 1/2 clinical trial of VTP-200, an immunotherapeutic in development for the treatment of high-risk and persistent HPV infection
Completed a $168 million Series B financing. This includes $43 million of proceeds from previously issued convertible loan notes that converted into Series B shares
Appointed three independent members to its Board of Directors
Initiated patient dosing in HBV002, a Phase 1b/2a clinical trial of VTP-300, an immunotherapeutic candidate in development for the treatment of chronic HBV infection
Upcoming Milestones

Third quarter of 2021: VTP-300 topline safety and immunogenicity results of the Phase 1 trial, HBV001, in healthy volunteers and patients with chronic HBV infection
Third quarter of 2021: VTP-600 dosing initiation in patients with non-small cell lung cancer in combination with a checkpoint inhibitor and chemotherapy
Fourth quarter of 2021: VTP-300 interim efficacy review, including surface antigen loss, of HBV002, the Phase 1/2a clinical trial in patients with chronic HBV infection
First quarter of 2022: VTP-200 interim efficacy review of HPV100, the Phase 1/2a clinical trial in patients with high-risk and persistent HPV infection
First Quarter 2021 Financial Highlights:

Cash position: As of March 31, 2021, cash and cash equivalents were $155.9 million, compared to $43.3 million as of December 31, 2021. The increase was primarily due to completion of the Series B financing. Subsequent to the end of the first quarter, the Company closed an initial public offering that raised a gross amount of $110.5 million. The Company believes its cash and cash equivalents are sufficient to fund operations into 2024.
Research and development (R&D) expenses: Research and development expenses were $4.6 million for the first quarter of 2021 compared to $4.2 million for the comparable period of the prior year. The increase in R&D expense was primarily due to increased spending on progressing VTP-300 and VTP-850 development.
General and administrative expenses: General and administrative expenses were $1.8 million for the first quarter of 2021 compared to $1.1 million for the comparable period of the prior year. The increase was primarily attributable to higher personnel costs driven by an increase in the Company’s headcount between the quarters and higher professional fees.
Other expenses: Other expenses, net were $9.3 million for the first quarter of 2021 compared to $0.7 million of income for the comparable period of the prior year. The increase in other expenses was primarily attributable to loss on extinguishment of convertible loan notes of $13.8 million and interest on loan notes of $2.7 million in the period, net of gain in fair value of derivatives of $6.0 million.
Net loss: The company generated a net loss of $15.3 million, or $1.90 per basic and diluted share, for the first quarter of 2021 compared to a net loss of $3.8 million, or $0.49 per basic and diluted share, for the comparable period of the prior year.

On June 16, 2021 Helix BioPharma Corp. (TSX: "HBP"), a an immuno-oncology company developing drug
candidates for the prevention and treatment of cancer, reported its financial results for the fiscal third quarter
ended April 30, 2021(Press release, Helix BioPharma, JUN 14, 2021, View Source [SID1234584026]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

OVERVIEW

The Company reported a net loss and total comprehensive loss of $2,554,000 and $5,268,000 for the three and
nine-month periods ended April 30, 2021. For the three and nine-month periods ended April 30, 2020, net loss and
total comprehensive loss totalled $2,489,000 and $6,896,000, respectively. The net loss and total comprehensive
loss for the three-month period ending April 30, 2021, includes a net loss of $nil (2020 – $198,000) and for the ninemonth period ending April 30, 2021 a gain of $1,536,000 (2020 – loss of $465,000) from discontinued operations.

The Company lost control of its subsidiary in Poland during the three-month period ending October 31, 2020 though
continued to exert significant influence until December 22, 2020 when the Company disposed of its remaining interest for gross proceeds of $2,308,000.

On June 14, 2021 Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on creating and delivering engineered cells as medicines, reported that data will be presented during two plenary sessions at the International Society for Stem Cell Research 2021 Virtual Annual Meeting, to be held Monday, June 21 through Saturday, June 26 (Press release, Sana Biotechnology, JUN 14, 2021, View Source [SID1234584008]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Chuck Murry, M.D., Ph.D., Sana’s Head of Cardiometabolic Cell Therapy, will be presenting "Genome Editing to Eliminate Engraftment Arrhythmia during Heart Regeneration" during the conference’s first plenary session, the Presidential Symposium titled ‘What’s in a Germ Layer?’ The session will begin on Monday, June 21 at 9:30 a.m. ET and will end at 11:45 a.m. ET.

Sonja Schrepfer, M.D., Ph.D., Sana’s Head of Hypoimmune Platform, will be speaking during the sixth plenary session on Cellular Therapy and Tissue Engineering, highlighting the Clinical Applications conference theme. She will present "Protecting Transplanted Stem Cells from Immune Rejection." The plenary session will begin on Saturday, June 26 at 9:30 a.m. ET and will end at 11:00 a.m. ET.

Both presentations will be rebroadcast at 9:30 p.m. ET on the day of their presentation and will be available to ISSCR registrants for on-demand viewing through July 31, 2021.

On June 14, 2021 Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, reported that two poster presentations of new clinical data and analyses related to imetelstat, the Company’s first-in-class telomerase inhibitor, are now available on Geron’s website as well as to participants of the EHA (Free EHA Whitepaper)2021 Virtual Congress (Press release, Geron, JUN 14, 2021, View Source [SID1234583987]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"These poster presentations further support imetelstat’s differentiated approach to potentially target the malignant stem and progenitor cells in the bone marrow by inhibiting telomerase activity," said Aleksandra Rizo, M.D., Ph.D., Geron’s Chief Medical Officer. "Through this novel mechanism of action, imetelstat has the potential to alter the course of MDS and MF which distinguishes it from other treatments currently approved or in development. We look forward to confirming these results in our ongoing Phase 3 clinical trials, IMerge Phase 3 in lower risk MDS and IMpactMF in refractory MF."

Title: Efficacy of Imetelstat is Independent of Molecular Subtypes in Heavily Transfused Non-Del(5q) Lower Risk MDS (LR-MDS) Relapsed/Refractory (R/R) to Erythropoiesis Stimulating Agents (ESA)
Poster Code: EP910

New data and analyses were presented on the clinical efficacy of imetelstat in molecularly defined subtypes based on cytogenetic and mutation profiles for patients in the IMerge Phase 2 clinical trial. As reported at previous EHA (Free EHA Whitepaper) meetings, meaningful and durable transfusion independence were observed in patients from IMerge Phase 2, including transfusion-free periods greater than one year, as well as substantial increases in hemoglobin. The current presentation reported clinical responses across different cytogenetic and molecularly defined categories whereby responses were independent of mutation status or number of mutations. These data support the unique telomerase inhibition mechanism of action of imetelstat and the potential to target the malignant stem and progenitor cells of the underlying disease.

Title: Imetelstat Demonstrates an Acceptable Safety Profile in Myeloid Malignancies
Poster Code: EP1106

Safety data from the Phase 2 IMbark and IMerge trials were further analyzed to understand the characteristics of hematologic and non-hematologic adverse events. These analyses highlighted that the imetelstat-related cytopenias are short, reversable and with limited clinical consequence when managed with the dose modification guidelines in the protocols. These data are further evidence for the on-target effect of imetelstat based on the selective reduction of malignant cells in the bone marrow through telomerase inhibition resulting in the observed meaningful clinical benefits for patients in the Phase 2 trials.

About Imetelstat

Imetelstat is a novel, first-in-class telomerase inhibitor exclusively owned by Geron and being developed in hematologic myeloid malignancies. Data from Phase 2 clinical trials provide strong evidence that imetelstat targets telomerase to inhibit the uncontrolled proliferation of malignant stem and progenitor cells in hematologic myeloid malignancies resulting in malignant cell apoptosis and potential disease-modifying activity. Imetelstat has been granted Fast Track designation by the United States Food and Drug Administration for both the treatment of patients with non-del(5q) lower risk MDS who are refractory or resistant to an erythropoiesis-stimulating agent and for patients with Intermediate-2 or High-risk MF whose disease has relapsed after or is refractory to janus kinase (JAK) inhibitor treatment.