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Vaccitech Reports First Quarter 2021 Financial Results and Recent Corporate Developments

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]).

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"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.

Helix Biopharma Corp. Announces Fiscal Third Quarter 2021 Results

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]).

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.

Sana Biotechnology to Present During Plenary Sessions at ISSCR 2021 Virtual Annual Meeting

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]).

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.

Geron Reports Two Presentations at Virtual European Hematology Association Annual Congress

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]).

"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.

With new data, Veracyte aims to expand prostate cancer test reach following Decipher acquisition

On June 14, 2021 Veracyte reported that $600 million to buy Decipher Biosciences and its genomic prostate cancer test (Press release, Veracyte, JUN 14, 2021, View Source [SID1234583986]). Now, that diagnostic has racked up new data showing it can help identify patients most likely to benefit from specific drugs.

Veracyte picked up urologic cancer specialist Decipher—itself once known as GenomeDx—in March in a cash deal to expand its diagnostic portfolio to seven of the 10 most common tumor types.

Its prostate test is already included in national cancer treatment guidelines, while its kidney and bladder cancer tests are in development, with the latter expected to launch later this year.

The new data—taken from a retrospective analysis of a phase 3 study of men with non-metastatic, castration-resistant prostate cancer, or nmCRPC, and published in JAMA Oncology—showed the test could use genomic data to judge which patients are most likely to see gains from early treatment with Janssen’s Erleada (apalutamide) alongside androgen-deprivation therapy.

RELATED: Veracyte drops $600M to acquire cancer tester Decipher Biosciences

The study is "the first clinical evaluation and demonstration of the Decipher test’s utility in the nmCRPC setting," said Veracyte’s senior VP for scientific and clinical operations in urologic cancers, Elai Davicioni, who added that the data helps demonstrate the test’s usefulness in multiple types of prostate cancer.

Previously, the study showed that Erleada combined with ADT could extend overall survival by 14 months and cut the risk of death by 22%. It also showed improvements in metastasis-free survival and other secondary endpoints. Annually, nmCRPC is estimated to affect about 60,000 men in the U.S.

The Decipher diagnostic relies on gene expression profiling to split patients into groups with low, average and high risks of metastasis, as well as by their tumor’s genetic subtype—with those with higher risks seeing the greatest benefits from Erleada therapy.

RELATED: J&J won’t pursue Erleada, Zytiga prostate cancer combo after trial results disappoint

The results "suggest that genomic testing provides useful information to guide treatment decisions that may improve outcomes among men with locally advanced disease, a population for which we’ve previously lacked genomic biomarkers," said the paper’s primary author, Felix Feng, vice chair for translational research in the department of radiation oncology at the University of California, San Francisco.

In addition, the molecular signature can help guide treatment decisions for years after an initial diagnosis, once the cancer has advanced locally, the company said.

RELATED: ASCO (Free ASCO Whitepaper): New data set up Veracyte’s nasal swab lung cancer test for launch later this year

The Decipher genomic classifier is currently being tested in seven randomized phase 3 prostate cancer trials sponsored by the National Cancer Institute, plus 13 more phase 2/3 trials, as well as more than 20 retrospective studies of phase 3 data, according to Veracyte.