MEI Pharma Announces Closing of Public Offering of Common Stock

On December 6, 2021 MEI Pharma, Inc. (Nasdaq: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, reported that it has closed the previously announced underwritten public offering of 20,125,000 shares of its common stock, which includes 2,625,000 shares of common stock sold as a result of the full exercise by the underwriters of an option to purchase additional shares of common stock, at $2.60 per share for total gross proceeds, before underwriting commissions and estimated expenses, of approximately $52,325,000 (Press release, MEI Pharma, DEC 6, 2021, View Source [SID1234596518]).

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The Company plans to use the net proceeds of the offering, together with other available funds, to progress its clinical development programs, prepare for and support the commercial launch of zandelisib, subject to receiving FDA marketing approval, and for other general corporate purposes.

Jefferies, Stifel and Wells Fargo Securities acted as joint book-running managers for the offering. LifeSci Capital and H.C. Wainwright & Co. acted as co-managers for the offering.

The securities described above are being offered pursuant to a "shelf" registration statement previously filed and declared effective by the Securities and Exchange Commission (SEC). The offering is being made only by means of a prospectus supplement and accompanying base prospectus.

When available, copies of the final prospectus supplement and accompanying base prospectus relating to the offering may be obtained from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022 or by email at [email protected]; Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at 415-364-2720 or by email at [email protected]; or Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 500 West 33rd Street, New York, New York 10001 at 833-690-2713 or email a request to [email protected]. An electronic copy of the final prospectus supplement and accompanying base prospectus relating to the offering will also be available on the website of the SEC at www.sec.gov.

This release does 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 jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.

ImmunoGen Announces Closing of Public Offering and Full Exercise of Underwriters’ Option to Purchase Additional Shares

On December 6, 2021 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported the closing of its previously announced underwritten public offering of 17,486,364 shares of its common stock, which reflects the exercise in full by the underwriters of their option to purchase up to 5,850,000 additional shares of common stock, and pre-funded warrants to purchase 27,363,636 shares of its common stock (Press release, ImmunoGen, DEC 6, 2021, View Source [SID1234596517]). The shares of common stock were sold at a price of $6.60 per share and the pre-funded warrants were sold at a price of $6.59 per pre-funded warrant, which represents the per share public offering price for the common stock less the $0.01 per share exercise price for each such pre-funded warrant, in each case before underwriting discounts and commissions. All of the shares of common stock and pre-funded warrants in the offering were sold by ImmunoGen.

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The total gross proceeds from the offering (before deducting the underwriting discounts and offering expenses) were $295.7 million.

ImmunoGen intends to use the net proceeds of the offering to fund its operations, including, but not limited to, commercialization activities, clinical trial activities, supply of drug product, business development activities, capital expenditures, and working capital.

Jefferies, Cowen, and Guggenheim Securities acted as joint book-running managers for the offering. Canaccord Genuity acted as lead manager for the offering.

The securities described above were offered by ImmunoGen pursuant to a shelf registration statement that was previously filed with the Securities and Exchange Commission (SEC) and became effective upon filing. This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in this offering, 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. A final prospectus supplement and accompanying prospectus relating to the offering was filed with the SEC and is available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by e-mail at [email protected] or by telephone at (877) 821-7388; Cowen and Company, LLC c/o Broadridge Financial Solutions, Attention: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY, 11717, by email at [email protected] or by telephone at (833) 297-2926; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, or by email at [email protected] or by telephone at (212) 518-9544.

Precision BioSciences to Host Virtual Webcast and Conference Call to Review Interim Phase 1/2a PBCAR0191 CAR T Data and Provide CAR T Program Updates on Saturday, December 11, 2021

On December 6, 2021 Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage biotechnology company using its ARCUS genome editing platform to develop allogeneic CAR T and in vivo gene editing therapies, reported it will review interim data results presented at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting from the PBCAR0191 CD19 allogeneic CAR T program and provide other CAR T program updates during a company-hosted webcast and conference call on Saturday, December 11, 2021 at 7:30 PM ET (Press release, Precision Biosciences, DEC 6, 2021, View Source [SID1234596516]).

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Precision previously announced that abstracts accepted by ASH (Free ASH Whitepaper) are now available at www.hematology.org, and the following two abstracts will be presented during oral presentation sessions:

Oral Presentation: #626. Allogeneic CAR-T PBCAR0191 with Intensified Lymphodepletion is Highly Active in Subjects with Relapsed/Refractory B-cell Malignancies (Abstract #302)
Presenting Author: Bijal Shah, M.D., Moffitt Cancer Center
Date/Time/Location: Saturday, December 11, 2021 at 4:15 PM ET in the Georgia World Congress Center, B401-B402

Oral Presentation: #704. Preliminary Safety and Efficacy of PBCAR0191, an Allogeneic ‘Off-the-Shelf’ CD19-Directed CAR-T for Patients with Relapsed/Refractory (R/R) CD19+ B-ALL (Abstract #650)
Presenting Author: Nitin Jain, M.D., The University of Texas MD Anderson Cancer Center
Date/Time/Location: Monday, December 13, 2021 at 10:45 AM ET in the Georgia World Congress Center, Sidney Marcus Auditorium

Company-Hosted Webcast and Conference Call Information
Precision will host a conference call and webcast on Saturday, December 11, 2021 at 7:30 PM ET to discuss interim data results for PBCAR0191 presented at the ASH (Free ASH Whitepaper) annual meeting, as well as additional updates regarding its allogeneic CAR T pipeline. This event is not an official program of the ASH (Free ASH Whitepaper) annual meeting. The dial-in conference call numbers for domestic and international callers are (866) 996-7202 and (270) 215-9609, respectively. The conference ID number for the call is 1178837. Participants may access the live webcast, and accompanying presentation materials, as well as the archived webcast on Precision’s website in the Investors section under Events & Presentations: View Source

Guardant Health Presents Data Demonstrating Utility of Comprehensive Genetic Profiling with Guardant360® Liquid Biopsy Test to Guide Treatment for Advanced Breast Cancer Patients at 2021 San Antonio Breast Cancer Symposium

December 6, 2021 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported it will present new data demonstrating the benefits of using the Guardant360 liquid biopsy test to help guide targeted therapy options for patients with advanced breast cancer at the 2021 San Antonio Breast Cancer Symposium (SABCS) on December 7-11 (Press release, Guardant Health, DEC 6, 2021, View Source [SID1234596514]). These studies were based on data from the GuardantINFORM real-world clinical genomic platform, which features extensive de-identified genomic data and aggregated commercial payer claims from advanced cancer patients who received the Guardant360 liquid biopsy assay.

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Data from one study (Abstract P5-13-29) confirmed that patients with BRCA1/2 reversion mutations, thought to cause acquired therapeutic resistance, experienced worse survival outcomes when treated with a PARP inhibitor as compared to patients without reversion mutations. The study also validates recent advancements in homologous recombination deficiency (HRD) assessment in the Guardant360 lab developed test (LDT), detecting additional inactivating alterations in BRCA1/2, including copy number loss and large genomic rearrangements. These data further demonstrate the Guardant360 test’s ability to reliably identify patients with advanced breast cancer who are most likely to benefit from PARP inhibitor treatment.

Another study (Abstract P1-18-07) using the GuardantINFORM platform demonstrated that, for advanced breast cancer patients with PIK3CA mutations identified using the Guardant360 liquid biopsy and subsequently treated with alpelisib, there was no significant difference in treatment outcomes regardless of whether they had clonal or subclonal PIK3CA mutations. This suggests patients with these mutations may benefit from alpelisib targeted therapy irrespective of mutation clonality.

"These studies further support the tremendous value that our Guardant360 liquid biopsy test and GuardantINFORM real-world clinical genomic platform bring to physicians, and most importantly the patients they treat," said Helmy Eltoukhy, Guardant Health Co-CEO. "Guardant360 identifies mutations driving the cancer, which enables the physician to match a patient with the right precision therapy without the need for a tissue biopsy, which can be difficult and time-consuming, potentially delaying treatment for patients with advanced breast cancer."

Full List of Guardant Health Presentations:

Analytical and clinical validation of a ctDNA assay for detecting copy number loss and structural rearrangement variants contributing to homologous recombination and repair (HRR) deficiency (Abstract Number: P5-13-29)
Impact of PIK3CA mutation (PIK3CA-mt) clonality on alpelisib (ALP) activity based on real-world evidence (RWE) following liquid biopsy testing (Abstract Number: P1-18-07)
SOLTI-1903 HOPE: Real-world clinical practice study to assess the impact of using genomic data on the next treatment decision making-choice in patients with locally advanced or metastatic breast cancer in Spain (Abstract Number: OT2-06-01)
Early changes in circulating tumor DNA and its effect on clinical outcomes in patients with advanced breast cancer receiving the CDK4/6 inhibitor palbociclib: Genotyping results from POLARIS (Abstract Number: P1-18-05)
The full abstracts can be found at the official SABCS website here.

About the Guardant360 Liquid Biopsy Test

The Guardant360 liquid biopsy test is part of the market leading Guardant360 portfolio that offers oncologists end-to-end testing solutions from treatment selection to treatment response monitoring. Since it was first introduced, the Guardant360 liquid biopsy test has become widely accepted for blood-based comprehensive genomic profiling (CGP) with more than 250 peer-reviewed publications including over 60 clinical outcomes studies. It has been trusted by more than 9,000 oncologists with more than 200,000 tests performed to date.

About GuardantINFORM

The GuardantINFORM clinical-genomic platform is intended to help accelerate research and development of the next generation of cancer therapeutics by offering biopharma partners an in-silico platform that combines de-identified longitudinal clinical information and genomic data collected from the Guardant360 liquid biopsy test. With data from more than 160,000 patients diagnosed with locally advanced and metastatic cancers, this robust dataset offers real-world insights into anti-cancer therapy use in the clinic, tumor evolution, and treatment resistance throughout each patient’s treatment journey for many advanced solid tumor cancers, including non-small cell lung, breast, colon, and prostate.

BostonGene Announces Three Oral and Four Poster Presentations at the 63rd American Society of Hematology (ASH) Annual Meeting & Exposition

On December 6, 2021 BostonGene Corporation, a biomedical software company committed to defining optimal precision medicine-based therapies for cancer patients, reported that seven abstracts were selected for presentations at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition (Press release, BostonGene, DEC 6, 2021, View Source [SID1234596513]). The event will be held from December 11 – 14, 2021 at the Georgia World Congress Center. BostonGene will exhibit in booth #3765.

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"We’re honored to have multiple presentations accepted by the ASH (Free ASH Whitepaper) Program Committee. Our presentations underscore the power of integrated analysis to discover distinct characteristics of the tumor microenvironment associated with clinical outcome to diverse therapeutic regimens in lymphoma," said Nathan Fowler, MD, Chief Medical Officer at BostonGene.

Details of the oral and poster presentations are below:

Oral presentations:

Title: High Rates of Remission with the Initial Treatment of Oral Azacitidine Plus CHOP for Peripheral T-Cell Lymphoma (PTCL): Clinical Outcomes and Biomarker Analysis of a Multi-Center Phase II Study
Abstract Number: 138
Session: 624. Hodgkin Lymphomas and T/NK cell Lymphomas
Time and Location: Saturday, December 11, 2021: 1:15 PM, Thomas Murphy Ballroom 3-4
Presenter: Jia Ruan, MD, PhD, Weill Cornell Medicine and New York Presbyterian Hospital

Research conducted by Weill Cornell Medicine, Memorial Sloan Kettering Cancer Center, Washington University School of Medicine, Moffitt Cancer Center and BostonGene.

Title: Phase 2 Study of Acalabrutinib Window Prior to Frontline Therapy in Untreated Aggressive B-Cell Lymphoma: Preliminary Results and Correlatives of Response to Acalabrutinib
Abstract Number: 524
Session: 626. Aggressive Lymphomas Prospective Therapeutic Trials
Time and Location: Sunday, December 12, 2021: 4:45 PM, Thomas Murphy Ballroom 1-2
Presenter: Mark Roschewski, MD, National Cancer Institute, National Institutes of Health

Research conducted by the National Cancer Institute (NCI), the National Institute of Allergy and Infectious Diseases (NIAID), both part of the National Institutes of Health (NIH), Stanford University and BostonGene.

Title: The Combination of Duvelisib and Romidepsin (DR) Is Highly Active Against Relapsed/Refractory Peripheral T-Cell Lymphoma with Low Rates of Transaminitis: Final Results and Biomarker Analysis
Abstract Number: 619
Session: 624. Hodgkin Lymphomas and T/NK cell Lymphomas
Time and Location: Monday, December 13, 2021: 10:30 AM, Hall A1
Presenter: Steven Horwitz, MD, Memorial Sloan Kettering Cancer Center

Research conducted by Memorial Sloan Kettering Cancer Center, Dana Farber Cancer Institute, Harvard Medical School, Washington University in St. Louis, Stanford University and BostonGene.

Poster presentations:

Title: HHV-6 in the Lymphoma Microenvironment: Both Chicken and Egg?
Abstract Number: 1377
Session: 624. Hodgkin Lymphomas and T/NK cell Lymphomas
Time and Location: Saturday, December 11, 2021: 5:30 PM – 7:30 PM
Presenter: Genevieve Crane, MD, PhD, Cleveland Clinic

Research conducted by Weill Cornell Medicine, Cleveland Clinic, Memorial Sloan Kettering Cancer Center, Columbia University and BostonGene.

Title: Immune-Depleted Tumor Microenvironment Signature Is Associated with BTK Inhibitor Resistance in Mantle Cell Lymphoma
Abstract Number: 1321
Session: 621. Lymphomas: Translational—Molecular and Genetic
Time and Location: Saturday, December 11, 2021: 5:30 PM – 7:30 PM, Hall B5
Presenter: Preetesh Jain, MBBS, MD, DM, PhD, The University of Texas MD Anderson Cancer Center

Research conducted by MD Anderson and BostonGene.

Title: A Prospective Study of Clonal Evolution in Follicular Lymphoma: Circulating Tumor DNA Correlates with Overall Tumor Burden and Fluctuates over Time without Therapy
Abstract Number: 524
Session: 621. Lymphomas
Time and Location: Saturday, December 11, 2021, 5:30 PM – 7:30 PM, Hall B5
Presenter: Allison Distler, National Cancer Institute, National Institutes of Health and George Washington University

Research conducted by the National Cancer Institute (NCI), National Institutes of Health (NIH), George Washington University, Adaptive Biotechnologies and BostonGene.

Title: Topographic Analysis of Low-Grade Myeloid Neoplasms By Multiparametric in Situ Imaging of Human Bone Marrow Core Biopsy Tissues
Abstract Number: 2593
Session: 636. Myelodysplastic Syndromes—Basic and Translational
Time and Location: Sunday, December 12, 2021: 6:00 PM – 8:00 PM, Hall B5
Presenter: Sanjay Patel, MD, MPH, MSc, Weill Cornell Medicine

Research conducted by Weill Cornell Medicine and BostonGene.

In addition to the oral and poster presentations, the abstracts have been published online in the November supplemental issue of "Blood".