On November 15, 2021 Vaccibody reported that (Press release, Vaccibody, NOV 15, 2021, View Source [SID1234595955])

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HIGHLIGHTS:
 Initiated the Phase 1b clinical trial in patients with locally advanced and metastatic tumors (VB N-02) in collaboration with Genentech (VB10.NEO individualized vaccine). First site opened in the USA
 Entered into worldwide license agreement with Adaptive Biotechnologies for clinically validated SARS-CoV-2 T cell epitopes Highlights after September 30, 2021:
 First subject dosed in a two-arm phase 1/2 clinical trial with a second generation and a third generation SARS-CoV-2 vaccine candidate  Reached a headcount of more than 100 people
 Continues to explore a potential listing of the company’s shares on Nasdaq and expects during 2022 to apply for a transfer of the listing of its shares to the main market of Oslo Stock Exchange R&D UPDATE Vaccibody’s modular technology platform is very versatile and may be adapted to generate the desired immune response profile. Hence, Vaccibody’s platform may be applied across a broad range of immunotherapy areas as innovative solutions to an unmet medical need. Vaccibody continues to increase the headcount across all functions including R&D to continue to build competencies and support the strategy execution. Please find below an update on Vaccibody’s current research and development activities.

Oncology VB10.16 VB10.16 is a therapeutic HPV vaccine directed against HPV16+ induced malignancies:
 Clinical trial VB C-02: o Clinical stage: Phase II o Indication: HPV16+ advanced, non-resectable cervical cancer o Up to 50 patients o ClinicalTrials.gov Identifier: NCT04405349 Vaccibody AS, Gaustadalléen 21, 0349 Oslo, Norway www.vaccibody.com Org.nr. 990 646 066 4 Status and highlights Investigational sites in 6 European countries are screening and enrolling patients. The trial is on track to complete enrolment during fourth quarter 2021. Vaccibody plans to report interim clinical data by the end of Q1 2022. The commercial potential in other HPV16 driven cancer indications such as HNSCC (Head and neck squamous cell carcinoma) is being explored. A development strategy update for VB10.16 will follow in 1H 2022

. VB10.NEO VB10.NEO is an individualized neoantigen cancer vaccine, exclusively licensed to Genentech:  Clinical trial VB N-01: o Clinical stage: Phase I/IIa o Cancer indications: Melanoma, non-small cell lung cancer (NSCLC), clear renal cell carcinoma, urothelial cancer or squamous cell carcinoma of the head and neck (SCCHN) o Fully enrolled o ClinicalTrials.gov Identifier: NCT03548467  Clinical trial VB N-02: o Clinical stage: Phase Ib o Cancer indications: Locally advanced and metastatic tumors o Up to 40 patients o ClinicalTrials.gov Identifier: NCT05018273 Status and highlights The first clinical site in the USA has been opened. The work on further site initiations in the USA and Europe continues. Infectious Diseases Vaccibody’s infectious disease initiatives spans both pre-clinical and clinical activities. VB10.COV2 Vaccibody has selected a 2-arm strategy for the VB10.COV2 project to fight SARS-CoV-2 variants of concern. VB10.2129 and VB10.2210 are two vaccine candidates designed based on Vaccibody’s modular and APC targeted technology:  In clinical trial VB-D-01, the two vaccine candidates, VB10.2129 and VB10.2210, are being investigated in previously vaccinated healthy volunteers. o VB10.2129-2nd generation vaccine addressing novel CoV-2 variants of concernVB10.2210-3rd generation universal broadly protective T cell vaccine, including T cell epitopes validated by Adaptive Biotechnologies

 Clinical stage: Phase 1/2
 Pathogen: SARS CoV-2  Up to 160 patients
 ClinicalTrials.gov Identifier: NCT05069623 Status and highlights Vaccibody reached the internal milestone of dosing the first subject with VB10.2129 in early November 2021.

With Vaccibody’s flexible and modular technology platform, it took only 267 days from design to first subject dosed. OTHER INFECTIOUS DISEASES Vaccibody has over the last years generated promising pre-clinical data in other infectious disease models. The Company has therefore initiated research discovery programs to explore and evaluate a focused set of pathogens as potential future clinical vaccine targets. Autoimmune disorders Autoimmune disorders are caused by unwanted immunogenicity to autoantigens.

Vaccibody continues to explore the modular technology platform and unique APC targeting approach to generate pre-clinical proof-of-concept for the ability to induce meaningful antigen-specific immune tolerance. The Company is investing significantly in the research area and is hiring to build further capacity and know-how. OTHER Capital market considerations Vaccibody continues to explore a potential listing of the company’s shares on the Nasdaq Global Market in the United States as first communicated in 1H 2021.

Furthermore, the Company expects during 2022 to apply for a transfer of the listing of its shares on the Oslo Stock Exchange from Euronext Growth Oslo to Oslo Børs, the main market of the Oslo Stock Exchange.

On November 15, 2021 Valo Health, LLC ("Valo"), the technology company using human-centric data and artificial intelligence (AI) powered computation to transform the drug discovery and development process and Khosla Ventures Acquisition Co. (Nasdaq: KVSA) ("KVSA"), a special purpose acquisition company sponsored by affiliates of Khosla Ventures, LLC, reported that both companies have mutually agreed to terminate their previously announced agreement and plan of merger (the "Business Combination Agreement"), effective immediately (Press release, Valo Health, NOV 15, 2021, View Source [SID1234595734]).

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Both parties decided to terminate the Business Combination based on current market conditions, particularly in the biotechnology area.

"We formed KVSA to merge with companies that are impactful to the world as we recently did with KVSB when we merged with Nextdoor," said Samir Kaul, Founding Partner and Managing Director at Khosla Ventures. "Valo Health is a strong company and we wish them continued success as they move forward on a very solid plan. We will continue to look for other high-impact targets across a range of industries to deliver maximum shareholder value."

"We made this decision to ensure that Valo continues to be in an optimal position of strength to pursue our growth strategy and to deliver on our mission to transform drug discovery and development," said David Berry, Founder & CEO. "Our team has worked hard to ensure that all of the fundamentals of our business are strong. As we move closer to launching our first Phase 2 trial this year, our second Phase 2 trial in the first half of next year, and continue to aggressively build out the additional unique capabilities of our platform, we have tremendous momentum going into 2022 and beyond."

On November 15, 2021 Checkmate Pharmaceuticals, Inc. (NASDAQ: CMPI) ("Checkmate"), a clinical stage biopharmaceutical company focused on developing its proprietary technology to harness the power of the immune system to combat cancer, reported that Alan Fuhrman, Interim CEO and President, will present at the Piper Sandler 33rd Annual Virtual Healthcare Conference (Press release, Checkmate Pharmaceuticals, NOV 15, 2021, View Source [SID1234595709]). The pre-recorded webcast will be available on-demand beginning on Monday, November 22 at 10:00am ET through Thursday, December 2, 2021. Checkmate will also host 1×1 investor meetings during the conference.

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The webcast can be accessed under "Events & Presentations" in the Investors section of the Checkmate website. An archived copy of the webcast will be available on the Checkmate website for approximately 90 days after the event.

On November 15, 2021 CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company developing mitochondria based therapeutics to treat chronic diseases and extend healthy lifespan, reported its financial results for the third quarter ended September 30, 2021 (Press release, CohBar, NOV 15, 2021, View Source [SID1234595708]).

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"We were pleased to report positive topline data from our first clinical study this past quarter and believe that this data not only demonstrates the potential of our CB4211 program but also validates our unique approach of creating novel therapeutics sourced from the mitochondrial genome," stated Dr. Joseph Sarret, Chief Executive Officer. "With a strengthened balance sheet from our recent financing, we are now well-positioned to continue to advance our pipeline."

Third Quarter 2021 and Recent Highlights

Positive Topline Data Announced from the Phase 1a/1b Study of CB4211 Being Developed for the Treatment of Nonalcoholic Steatohepatitis (NASH) and Obesity: In August, the company announced topline results from the multi-center, randomized, double-blind, placebo-controlled Phase 1a/1b clinical study of CB4211, under development for NASH and obesity. The study met its primary endpoints as CB4211 was well-tolerated and appeared safe with no serious adverse events. The evaluation of the exploratory endpoints showed robust and statistically significant improvements in key biomarkers of liver damage, ALT and AST, as well as in glucose levels in the CB4211 group compared to placebo. There was a trend towards lower body weight in the CB4211 group after four weeks of treatment.
CB4211 Phase 1b Data Selected for Late Breaker Presentation at The Liver Meeting 2021: In October, the company announced that data from its CB4211 Phase 1a/1b clinical study had been selected for presentation during the late-breaking poster session at The American Association for the Study of Liver Diseases (AASLD) Annual Meeting (The Liver Meeting 2021). The lead author on the poster was Dr. Rohit Loomba, MD, MHSc, Professor of Medicine, Director, NAFLD Research Center, and Director of Hepatology, University of California at San Diego. The poster can be viewed by visiting: CohBar’s Publication Page.
U.S. Patent Granted Covering CB4211 Compositions and Use for Treating NASH: In September, the company announced that the United States Patent and Trademark Office had granted a patent covering CohBar’s lead candidate CB4211 and related compositions, as well as methods of treatment, including methods of treating NASH. This foundational patent will be eligible for listing in the FDA Orange Book upon approval of CB4211 as a therapeutic in the United States.
Completed $15M Financing: On November 1st, the company completed an underwritten public offering of common stock and warrants, with aggregate gross proceeds of approximately $15 million. The company intends to use the proceeds from this offering to fund research and development and other general corporate purposes.
Gained additional bank research coverage: Recently, Wall Street bank Cantor Fitzgerald initiated coverage on CohBar and issued a research report on the company.
Carol Nast and Joanne Yun, Ph.D. Appointed to the Board of Directors: The company announced the appointment Carol Nast and Joanne Yun, Ph.D. as independent directors. Ms. Nast has spent her career in executive level positions with both large multinational companies and early-stage companies in the medical industry. Dr. Yun brings extensive research and development, commercial, and governance experience from the pharmaceutical industry.
Third Quarter 2021 Financial Highlights

Cash and Investments: The company had cash and investments of $15 million as of September 30, 2021, compared to $21 million as of December 31, 2020. The cash burn for the quarter ended September 30, 2021, was approximately $3.3 million.

R&D Expenses: Research and development expenses were $1.6 million for the three months ended September 30, 2021, compared to $1.2 million in the prior year quarter. The increase in research and development expenses was primarily due to the investment in the company’s research programs focused on the continued development of its peptides partially offset by a decrease in stock based compensations costs.

G&A Expenses: General and administrative expenses were $1.8 million for the three months ended September 30, 2021, compared to $1.4 million in the prior year quarter. The increase in general and administrative expenses was primarily due to higher stock-based compensation costs.

Net Loss: For the three months ended September 30, 2021, net loss, which included $0.7 million of non-cash expenses, was $3.4 million, or $0.05 per basic and diluted share. For the three months ended September 30, 2020, net loss, which included $0.9 million of non-cash expenses, was $3.2 million, or $0.06 per basic and diluted share.
Third Quarter Investor Call:

For individuals participating in the Investor Call, please call into the conference audio approximately 10 minutes prior to its start.

An audio replay of the call will be available beginning at 8:00 p.m. Eastern Time on November 15, 2021, through 11:59 p.m. Eastern Time on December 6, 2021. To access the recording please dial (844) 512-2921 in the U.S. and Canada, or (412) 317-6671 internationally, and reference Conference ID# 10161656. The audio recording will also be available at www.cohbar.com during the same period.

On November 15, 2021 Cytokinetics, Incorporated (Nasdaq: CYTK) reported that Robert I. Blum, President and Chief Executive Officer, is scheduled to participate in a fireside chat at the Piper Sandler 33rd Annual Virtual Healthcare Conference taking place November 30, 2021 to December 2, 2021 (Press release, Cytokinetics, NOV 15, 2021, View Source [SID1234595707]).

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The pre-recorded fireside chat will be available for on-demand viewing beginning November 22, 2021 at 10:00 AM ET. Interested parties may access it by visiting the Investors & Media section of the Cytokinetics website at www.cytokinetics.com. A replay of the fireside chat will be archived on the Presentations page within the Investors & Media section of Cytokinetics’ website for 90 days.