On November 15, 2021 Savara Inc. (Nasdaq: SVRA), a clinical stage biopharmaceutical company focused on rare respiratory diseases, reported that its management team will present at the following healthcare conferences (Press release, Savara, NOV 15, 2021, View Source [SID1234595632]):

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Piper Sandler 33rd Annual Virtual Healthcare Conference: A pre-recorded webcast of the presentation will be available beginning at 10:00 AM ET / 7:00 AM PT on November 22, 2021.
Evercore ISI 4th Annual HealthCONx Virtual Conference: A live webcast of a fireside chat will take place at 8:50 AM ET / 5:50 AM PT on November 30, 2021.
Both webcasts will be available through the Investors page of Savara’s website at www.savarapharma.com/investors/events-presentations/ and will be archived for 90 days.

On November 15, 2021 Benitec Biopharma Inc. (NASDAQ: BNTC) ("Benitec" or "the Company"), a development-stage, gene therapy-focused, biotechnology company developing novel genetic medicines based on the proprietary DNA-directed RNA interference ("ddRNAi") platform, reported the financial results for its Fiscal Year Q1 ended September 30, 2021 (Press release, Benitec Biopharma, NOV 15, 2021, View Source [SID1234595648]). The Company has filed its quarterly report on Form 10-Q for the quarter ended September 30, 2021, with the U.S. Securities and Exchange Commission.

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Operational Updates

The key milestones related to the investigational agents under development by the Company and other corporate updates are outlined below:

BB-301 (Oculopharyngeal Muscular Dystrophy Program)

On September 8, 2021, Benitec provided three key updates related to the progress of the BB-301 development program, including: updated results for the BB-301 Pilot Dosing Study in large animals, updates on European and North American regulatory interactions for the BB-301 development program, and a comprehensive overview of the design of, and key primary and secondary endpoints for, the Phase 1b/2a clinical trial which is planned for initiation in 2022. All of the updates were positive and demonstrated the significant progress that has been achieved for the BB-301 development program; below is a summary of each update:
BB-301 Pilot Dosing Study in Large Animals: On September 8th the Company disclosed updated analyses for the animal subjects dosed with BB-301 in the Pilot Dosing Study. The updated data continued to demonstrate dose-dependent transduction of the target pharyngeal muscle tissues by BB-301, dose-dependent gene expression for the three distinct components of the therapeutic BB-301 transgene, and biologically significant levels of gene silencing ("knock-down") of the target PABPN1 protein. These updated data provide continued support for the planned advancement of BB-301 into the Phase 1b/2a clinical study in 2022.
Regulatory Interactions in Europe: Following the disclosure in February 2021 of the positive interim data from the BB-301 Pilot Dosing Study in large animals, Benitec completed a Scientific Advice Meeting with The National Agency for the Safety of Medicines and Health Products in France (L’Agence nationale de sécurité du médicament et des produits de santé or "ANSM") in the first half of 2021. At the conclusion of the meeting:
The BB-301 Pilot Dosing Study in large animals was viewed as an appropriate dose range finding study.
The design of the ongoing GLP Toxicology and Biodistribution study was viewed as appropriate to support Phase 1b/2a testing of BB-301.
The manufacturing plan for clinical grade BB-301 drug product can be conducted under GMP conditions with a production process analogous to that employed in prior large-scale production runs for BB-301.
The design of the Phase 1b/2a clinical trial can support the evaluation of BB-301 safety and clinical efficacy in key populations of OPMD patients.
Regulatory Interactions in the United States: Benitec has been granted a Type C Meeting with the U.S. Food and Drug Administration ("FDA") in the fourth quarter of 2021.
Regulatory Interactions in Canada: Benitec has been granted a Pre-CTA Consultation Meeting with Health Canada in the fourth quarter of 2021.
BB-301 Phase 1b/2a Clinical Study Design: On September 8th the Company provided a comprehensive overview of the key design elements of the upcoming BB-301 Phase 1b/2a clinical trial. The Phase 1b/2a study is planned for 2022. In addition to the determination of the safety and tolerability profiles of BB-301, the secondary endpoints of the trial will facilitate the accurate and reproducible characterization of the key physiological processes underlying the successful completion of the pharyngeal phase of swallowing. The core analytical tools and methods that will be employed during the clinical study will focus on functional measures of swallowing efficiency for OPMD patients during the pharyngeal phase of swallowing.
Financial Highlights

Total Revenues for the quarter ended September 30, 2021 were $0 compared to fifty-five thousand dollars in total revenue for three months ended September 30, 2020. The decrease in revenues from customers is due to the decrease in licensing and royalty revenues in the current period.

Total Operating Expenses were $4.8 million for the quarter ended September 30, 2021 compared to $2.7 million for the comparable period in 2020. For the quarters ended September 30, 2021 and 2020, respectively, Benitec incurred $0 and $134 thousand in royalties and license fees. During the three months ended September 30, 2021 and 2020, respectively, the Company incurred $2.8 million and $0.8 million in research and development expenses. The increase in research and development expenses is primarily related to the commencement of the BB-301 GLP Toxicology and Biodistribution Study in large animals at Charles River Laboratories. Additionally, the Company incurred expenses related to the production of GMP-grade drug product to facilitate submissions of the Clinical Trial Applications outside of the United States and the Investigational New Drug Application in the United States, as these activities are critical to the planned initiation of the Phase 1b/2a clinical trial for BB-301 in 2022. General and administrative expenses were $2.0 million and $1.8 million for the three months ended September 30, 2021 and 2020, respectively. The increase during this three-month period was due to small increases in insurance costs, consultant fees, and legal and accounting fees.

Jerel A. Banks, M.D., Ph.D., Executive Chairman and Chief Executive Officer of Benitec Biopharma commented, "Our team continues to focus on the core development activities that will ensure the advancement of BB-301 into the first-in-human study. Our primary goal has been, and will continue to be, the improvement of the lives of patients suffering from genetic disorders for which no curative interventions exist. We believe that the initiation of the Phase 1b/2a study is critical for patients in the Oculopharyngeal Muscular Dystrophy community and represents an important milestone with respect to our long-term goals as a company."

On November 15, 2021 ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported a business update and an update on its cash position at the end of September 2021 (Press release, ERYtech Pharma, NOV 15, 2021, View Source [SID1234595692]).

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"While the outcome of our TRYbeCA-1 trial in second-line pancreatic cancer did not achieve its primary endpoint of overall survival, we remain encouraged by the observed improvement of overall survival in a subset of patients treated with FOLFIRI and will continue analyzing the sizeable TRYbeCA-1 data set in order to distill the reasons for this disappointing outcome," said Gil Beyen, CEO of ERYTECH. "We are also encouraged by the progress we are making towards seeking an approval for eryaspase for the treatment of ALL patients who experienced hypersensitivities to pegylated asparaginase. The dialogue with the FDA is continuing and we are hopeful we can submit our first BLA around year end. We were pleased with the granting of the Fast Track designation for this high unmet need indication in July."

Business Highlights

Path to BLA in hypersensitive ALL, based on results of NOPHO-sponsored Phase 2 trial

The NOPHO trial evaluated the safety and pharmacological profile of eryaspase in acute lymphoblastic leukemia (ALL) patients who had previously experienced hypersensitivity reactions to pegylated asparaginase therapy. In December 2020, positive trial results were presented at the 2020 American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting.

Eryaspase in combination with chemotherapy, administered every two weeks, provided a sustained asparaginase enzyme activity level, and was generally well tolerated with few hypersensitivity reactions.

The Company continued its interactions with the U.S. Food and Drug Administration (FDA) regarding a potential regulatory approval in this indication based on the NOPHO-sponsored trial. A pre-BLA meeting to discuss the submission of a Biologics License Application (BLA) took place in June after which the Company confirmed its intention to submit a BLA subject to successful completion of remaining activities.
In July, the Company announced that the FDA had granted eryaspase Fast Track designation for the treatment of ALL patients who have developed hypersensitivity reactions to E. coli-derived pegylated asparaginase.
Subject to review of remaining information requests, the Company intends to submit a BLA around year-end.

TRYbeCA-1, pivotal Phase 3 clinical trial in second-line advanced pancreatic cancer

As reported in late October, the Phase 3 TRYbeCA-1 trial did not meet the primary efficacy endpoint of overall survival (OS). The median OS for patients treated with eryaspase plus chemotherapy was 7.5 months, compared to 6.7 months for chemotherapy alone, with an OS hazard ratio (HR) of 0.92 in the intent-to-treat (ITT) population (p-value 0.375).

The prespecified subgroup of patients treated with eryaspase and FOLFIRI, an irinotecan-based chemotherapy, demonstrated a nominal increase in median OS of 2.3 months, from 5.7 to 8 months (HR = 0.77; per protocol population), which the Company believes merits further investigation.
Patients treated with eryaspase demonstrated improved disease control compared to patients treated with chemotherapy only. Other secondary endpoints showed nominal improvement.
The safety profile of eryaspase was consistent with earlier clinical trials results and safety reviews.

Final data are being analyzed and will be presented at an upcoming medical conference.

rESPECT, Phase 1 investigator-sponsored trial (IST) in first-line pancreatic cancer

rESPECT is a Phase 1 trial, sponsored by the Georgetown Lombardi Comprehensive Cancer Center, evaluating the safety of eryaspase in combination with mFOLFIRINOX as a first-line treatment for locally advanced and metastatic pancreatic cancer in approximately 18 patients.

Patient enrollment started in January 2021, and the first dose cohort (75 U/kg) of three patients was enrolled by the end of February. No dose-limiting toxicity (DLT) was observed, and the trial was escalated to the next dosing cohort (100 U/kg).
After review of the safety data in the first two dose cohorts, the dose escalation committee concluded that the novel combination of mFOLFIRINOX plus eryaspase was well tolerated with no DLT. Consequently, the maximum tolerated dose (MTD) was determined at a dose of 100 U/kg eryaspase.
Additionally, all six patients evaluated for response achieved disease control; three patients with objective response and three with stable disease.

The trial will continue enrolling up to approximately 18 patients. Reporting of final data is expected in the first half of 2022.

TRYbeCA-2, randomized Phase 2 clinical trial in triple-negative breast cancer (TNBC)

The TRYbeCA-2 trial is evaluating eryaspase in combination with gemcitabine and carboplatin chemotherapy, compared to chemotherapy alone, in metastatic TNBC. Target enrollment is approximately 64 patients. The primary end point of the trial is objective response rate.

Following the disappointing results of eryaspase in combination with a gemcitabine-based chemotherapy in the TRYbeCA-1 trial in second-line pancreatic cancer, the Company has, in consultation with the trial’s Steering Committee, decided to stop further enrollment in the TRYbeCA-2 trial.

The results of the patients enrolled in the TRYbeCA-2 trial to date are expected to be reported in the first half of 2022.

Process to review strategic options and partnering alternatives launched

The Company launched a process and appointed a specialized advisor to evaluate its strategic and partnering alternatives, including for the further development and commercialization of eryaspase. Gil Beyen, the CEO of ERYTECH, will lead these partnering efforts and take on the role of acting Chief Business Officer (CBO), as Jean-Sebastien Cleiftie, current CBO of ERYTECH will leave the Company at the end of this month.

Update on Q3 2021 Cash Position

As of September 30, 2021, ERYTECH had cash and cash equivalents totaling €38.0 million (approximately $43.9 million), compared with €44.4 million as of December 31, 2020 and €46.3 million on June 30, 2021. The €6.5 million decrease in cash position during the first nine months of 2021 was the result of a €7.8 million net cash utilization, which was mostly comprised of a €46.2 million net cash utilization in operating activities, €0.3 million used for investing activities and €38.8 million generated in financing activities, while the variation of the U.S. dollar against the euro led to a €1.3 million positive currency exchange impact.

Financing activities in the first nine months of 2021 included a $8 million placement in the United States through the Company’s at-the-market (ATM) equity financing program for net proceeds of €6.4 million, a $30 million Registered Direct offering for net proceeds of €22.4 million, and the drawdown of four tranches under the convertible notes (OCABSA) financing agreement signed with Alpha Blue Ocean, for net proceeds of €11.4 million.

At the date of this press release, nine OCABSA tranches have been called since the initiation of the program in June 2020. During the last 12 months, the OCABSA converted notes, together with the shares issued under the ATM program, have resulted in the issuance of 4,690,904 new shares and 235,690 warrants, representing 17.6% of the Company’s outstanding share capital.

The Company believes that its current cash position can fund its planned operating expenses and current programs into the second quarter of 2022. Further, the Company has engaged in cash preservation measures and believes that these measures, together with further utilization of the OCABSA agreement, subject to the regulatory limit of 20% dilution, could extend its cash horizon into the third quarter of 2022. The Company is currently exploring potential financing and partnering options to further extend its cash horizon beyond key 2022 development milestones.

The release on October 25, 2021 of the TRYbeCA-1 Phase 3 trial in pancreatic cancer, which did not meet its primary endpoint, is considered a triggering event for impairment analysis, which will require the Company to test tangible and intangible assets for possible impairment. The Company is therefore not in a position to announce full financial results for the third quarter of 2021 until current uncertainties on business assumptions are clarified. The Company will conduct an impairment analysis in light of its new business situation, which may potentially lead to an impairment of some of its assets.

Key News Flow and Milestones Expected Over the Next 12 Months

Planned BLA submission of eryaspase in hypersensitive ALL (around year end 2021)
Results from the Phase 1 rESPECT Trial of eryaspase in combination with mFOLFIRINOX in first-line pancreatic cancer (1H 2022)
Presentation of full dataset of TRYbeCA-1 trial at a medical meeting (1H 2022)
Data from the randomized Phase 2 TRYbeCA-2 trial of eryaspase in TNBC (1H 2022)
Third Quarter 2021 Conference Call Details

ERYTECH management will hold a conference call and webcast on Tuesday, November 16, 2021 at 8:30am EST / 2:30 pm CET to discuss the recent business and financial updates. Gil Beyen, CEO, Eric Soyer, CFO/COO, and Iman El-Hariry, CMO, will deliver a brief presentation, followed by a Q&A session.

The audio call is accessible via the below registering link:

View Source (Conference ID : 6425429)

Once registered, participants will receive a unique access code and the call number details to join the teleconference.

The webcast can be followed live online via the link: View Source

An archived replay of the call will be available for 7 days by dialing + 1 855 859 2056, Conference ID: 6425429#.

An archive of the webcast will be available on ERYTECH’s website, under the "Investors" section at investors.erytech.com

Financial Calendar 2021

Business Update and Financial Highlights for the Fourth Quarter and Full Year 2021: March 11, 2022 (after U.S. market close), followed by a conference call & webcast on March 14, 2022 (2:30pm CET/8:30am ET)

ERYTECH plans on attending the following upcoming investor conferences:

Jefferies 2021 Global Healthcare Conference, November 16-19, London
LifeSci Partners 11th Annual Corporate Access Event, January 5-7, 2022
H.C. Wainwright, BioConnect Conference, January 10-13, 2022
JPMorgan HealthCare Conference, January 10-13, 2022, San Francisco

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 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.