On November 2, 2021 Synlogic, Inc. (Nasdaq: SYBX), a clinical stage company bringing the transformative potential of synthetic biology to medicine, reported the Company will release its third quarter 2021 financial results before the market opens on Wednesday, November 10, 2021 (Press release, Synlogic, NOV 2, 2021, View Source [SID1234594193]). The press release will be followed by a conference call at 8:30 am ET, which will be open to the public via telephone and webcast. During the conference call, the Company will review its financial results and provide a corporate update.

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The conference call dial-in numbers are (844) 815-2882 for domestic callers and (213) 660-0926 for international callers. The conference ID number for the call is 5450919. Participants may access the live webcast via a link on the Synlogic website in the Events Calendar of the Investors and Media section. For those unable to participate in the conference call or webcast, a replay will be available for 30 days on the Company’s website.

Additionally, Aoife Brennan, M.B. Ch.B., Synlogic’s President and Chief Executive Officer, will present at the following banking conference:

Jefferies London Healthcare Conference, November 18th and 19th. The Company presentation will be available on demand.
Synlogic’s pre-recorded session will be available for the duration of the conference and a replay will be available for 30 days on the Company’s website.

On November 2, 2021 Evotec SE’s (Frankfurt Stock Exchange; EVT, MDAX/TecDAX, ISIN: DE0005664809, WKN 566480) management board reported – with the approval of its supervisory board – on the volume and the issue price of its public offering of American Depositary Shares ("ADSs") (Press release, Evotec, NOV 2, 2021, View Source;announcements/ad-hoc-releases/p/evotec-se-announces-placement-of-its-public-offering-of-american-depositary-shares-6114 [SID1234594191]). The offering will produce gross proceeds of $ 435,000,000 from the sale of 10,000,000 ordinary shares of Evotec in the form of 20,000,000 ADSs at a price of $ 21.75 per ADS. Each ADS will represent one half of an ordinary share of Evotec. Accordingly, Evotec’s share capital, on the basis of Evotec’s articles of association ("Satzung"), will be increased to € 173,914,741,00 by issuing 10,000,000 shares from the authorized capital ("Genehmigtes Kapital 2021") under exclusion of subscription rights of the existing shareholders (taking into account the subscription shares issued to date from conditional capital ("Bezugsaktien"), the actual share capital will then amount to € 175,110,695).

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In addition, Evotec has granted the underwriters an option exercisable for 30-days after the date hereof to purchase up to 3,000,000 additional ADSs.

The ADSs are expected to begin trading on the Nasdaq Global Select Market on or about November 4, 2021 under the ticker symbol "EVO".

The offering is expected to close on or about November 8, 2021, subject to the satisfaction of customary closing conditions.

A registration statement relating to the ADSs being sold in this offering has been filed with the U.S. Securities and Exchange Commission and was declared effective on November 3, 2021.

The offering is being made only by means of a prospectus. Copies of the final prospectus relating to the offering may be obtained, when available, for free by visiting EDGAR on the SEC’s website at www.sec.gov. Alternatively, copies of of the final prospectus, when available, may be obtained from: BofA Securities, NC1-004-03-43; 200 North College Street, 3rd Floor, Charlotte, North Carolina 28255-0001, Attention: Prospectus Department or by email at [email protected], Morgan Stanley & Co. LLC, Attn: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014, or by email at [email protected].

This release shall not constitute an offer to sell or a 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 law of any such state or jurisdiction.

This communication and the information contained herein is made solely for information purposes only and does not constitute or form part of a prospectus or any offer or invitation to sell or issue, or any solicitation of any offer to purchase or subscribe for, any securities of Evotec, in any jurisdiction. Neither this communication, nor any part of it, nor the fact of its distribution, shall form the basis of, or be relied on in connection with, any contractual commitment or investment decision in relation to the securities of Evotec, in any jurisdiction, nor does it constitute a recommendation regarding any such securities.

The placement of the securities mentioned in this communication is directed only at persons in member states of the European Economic Area (the "EEA") who are "Qualified Investors" within the meaning of the Prospectus Regulation EU 2017/1129 ("Prospectus Regulation") ("Qualified Investors"). Any person in the EEA who acquires the securities in any offer (an "Investor") or to whom any offer of the securities is made will be deemed to have represented and agreed that it is a Qualified Investor.

In the United Kingdom, this communication is only directed at persons who are "qualified investors" within the meaning of Article 2 of the Prospectus Regulation as it forms part of domestic law by virtue of the European Union (Withdrawal) Act 2018 who are also (i) investment professionals falling within Article 19(5) of the UK Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the "Order") or (ii) high net worth entities, and other persons to whom it may lawfully be communicated, falling within Article 49(2) of the Order (all such persons together being referred to as "Relevant Persons"). Any investment or investment activity to which this communication relates is available only to Relevant Persons in the United Kingdom and will only be engaged with such persons. Any person in the United Kingdom who is not a Relevant Person should not act or rely on this communication or any of its contents.

This announcement contains forward-looking statements concerning future events, including the proposed offering and listing of Evotec’s securities. Words such as "anticipate," "believe," "could," "estimate," "expect," "intend," "may," "might," "plan," "potential," "should," "target," "would" and variations of such words and similar expressions are intended to identify forward-looking statements. Such statements include comments regarding completion of the offering. These forward-looking statements are based on the information available to, and the expectations and assumptions deemed reasonable by Evotec at the time these statements were made. No assurance can be given that such expectations will prove to have been correct. These statements involve known and unknown risks and are based upon a number of assumptions and estimates, which are inherently subject to significant uncertainties and contingencies, many of which are beyond the control of Evotec. Evotec expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Evotec’s expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based.

On November 2, 2021 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel LAG-3 related immunotherapy treatments for cancer and autoimmune disease, reported the grant of a new patent (number ZL 201610221687) entitled "Use of recombinant LAG-3 or the derivatives thereof for eliciting a monocyte immune response" by the Chinese Patent Office (Press release, Immutep, NOV 2, 2021, View Source [SID1234594190]). The patent forms part of a broad and growing portfolio of patent families for the Company’s lead product candidiate eftilagimod alpha ("efti" or "IMP321") in key global markets including China.

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This new Chinese patent follows the grant of the corresponding European, Japanese and United States patents announced previously. The claims of the new patent relate to methods of use of (a) Immutep’s efti which is a LAG-3 fusion protein (LAG-3Ig) and (b) a chemotherapy agent in combination for the manufacture of a preparation for the treatment of cancer. The patent provides protection in mainland China and the expiry date is 3 October 2028.

The new patent is owned by Immutep S.A.S. and exclusively licensed to Immutep’s partner in China, EOC Pharma ("EOC").

Immutep CEO, Marc Voigt, noted: "We are making good progress building our global patent estate around our LAG-3 development pipeline, including lead candidate efti which has delivered promising clinical data in various settings. We will continue to make these important investments and are especially pleased to be working so closely with our Chinese partner, EOC Pharma, as they expand their clinical development of efti for the Chinese market."

EOC Pharma CEO, Xiaoming Zou, said: "We are investing in the development of efti for the local market in China and are very pleased with the steps being taken by our partner, Immutep, to build a broad portfolio of patent families around this unique candidate. These are important and ongoing steps in the complex process of bringing innovative medicines to the market for patients."

About efti in China

Efti is exclusively licensed by Immutep to EOC Pharma for the territory of Greater China (namely mainland China, Hong Kong S.A.R, Macao S.A.R. and Taiwan). Under its agreement with Immutep, EOC will make further milestone payments to the Company if efti achieves specific development milestones, as well as pay sales-based royalties. Immutep retains the rights to efti outside the territory of Greater China.

On November 2, 2021 ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically targeted therapies for cardiovascular diseases, reported third quarter 2021 financial results and provided a corporate update (Press release, Arca biopharma, NOV 2, 2021, View Source [SID1234594189]).

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Dr. Michael Bristow, ARCA’s President and Chief Executive Officer, commented, "The continuing pandemic and the emergence of multiple variants that have led to a resurgence of infections and hospitalizations, highlight the need for additional safe and effective therapeutic tools to treat patients that develop severe COVID-19. With rNAPc2’s combination of anticoagulant, anti-inflammatory and potential antiviral properties, we believe it has the potential to be effective in addressing COVID-19 impacts in hospitalized patients. Our international Phase 2b clinical trial is nearing completion and we look forward to sharing its results in the first quarter."

Pipeline Update

rNAPc2 (AB201) – a small recombinant protein being developed as a potential treatment for COVID-19 and potentially other viral diseases.

On-going Phase 2b clinical trial (ASPEN-COVID-19) evaluating rNAPc2 as a potential treatment for patients hospitalized with COVID-19, enrolling patients at investigative sites in United States, Argentina and Brazil.
Clinical trial Data and Safety Monitoring Committee (DSMC) completed a pre-specified interim analysis and, based on the DSMC’s review of approximately 75% of the projected final efficacy and safety data, recommended completion of the clinical trial with no modifications to the clinical trial design.
Phase 2b topline data anticipated in first quarter of 2022.
GencaroTM (bucindolol hydrochloride) – a pharmacologically unique beta-blocker and mild vasodilator being developed as a potential genetically-targeted treatment for atrial fibrillation (AF) in patients with heart failure (HF).

ARCA currently has an agreement with the U.S. FDA, known as a Special Protocol Assessment, or SPA, for the requirements of a Gencaro Phase 3 clinical trial, PRECISION-AF, that would support potential approval of Gencaro if successful. The Company is currently evaluating the potential timing for initiation of PRECISION-AF relative to the COVID-19 pandemic and the ability to recruit patients for a cardiovascular clinical trial, and based on an improving clinical trial ecosystem, has begun organizing necessary trial logistics.
Third Quarter 2021 Summary Financial Results

Cash and cash equivalents were $58.3 million as of September 30, 2021, compared to $49.1 million as of December 31, 2020. ARCA believes that its current cash and cash equivalents will be sufficient to fund its operations through 2022.

Research and development (R&D) expenses were $3.4 million for the quarter ended September 30, 2021, compared to $1.1 million for the corresponding period in 2020. The $2.3 million increase in R&D expenses in the third quarter was primarily related to the initiation of the rNAPc2 clinical trial in the second half of 2020. R&D expenses in 2021 are expected to be higher than 2020 as the Company continues the rNAPc2 Phase 2b clinical trial.

General and administrative (G&A) expenses were $1.3 million for the quarter ended September 30, 2021, compared to $0.9 million for the corresponding period in 2020. The $0.4 million increase in G&A expenses was primarily a result of higher personnel costs in 2021. G&A expenses in the last quarter of 2021 are expected to be consistent with the third quarter of 2021 as the Company maintains administrative activities to support its ongoing operations.

Total operating expenses for the quarter ended September 30, 2021 were $4.7 million compared to $2.0 million for the third quarter of 2020.

Net loss for the quarter ended September 30, 2021 was $4.7 million, or $0.33 per basic and diluted share, compared to $2.0 million, or $0.33 per basic and diluted share for the third quarter of 2020.

On November 2, 2021 Perimeter Medical Imaging AI, Inc. (TSX-V:PINK) (OTC:PYNKF) (FSE:4PC) ("Perimeter" or the "Company"), a medical technology company driven to transform cancer surgery with ultra-high-resolution, real-time, advanced imaging tools to address high unmet medical needs, reported approval of its Investigational Device Exemption ("IDE") application by the U.S. Food and Drug Administration ("FDA") to conduct a multi-center, randomized, double-arm study to evaluate the FDA breakthrough-device-designated Perimeter B-Series OCT imaging system that uses ImgAssist AI technology to identify regions of interest as compared with the current standard of care for patients undergoing breast conservation surgery (Press release, Perimeter Medical Imaging AI, NOV 2, 2021, View Source [SID1234594166]). It is anticipated that over 300 patients across 8 U.S. clinical sites will participate in the pivotal study to be led by Principal Investigator, Dr. Alastair Thompson at Baylor College of Medicine.

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Jeremy Sobotta, Perimeter’s Chief Executive Officer stated, "This IDE approval marks another important milestone in our ATLAS AI project, building upon the ‘Breakthrough Device Designation’ that we received in April, as we transition into clinical validation of the AI-enabled, next generation of our commercially available flagship OCT imaging technology. Trial start-up activities are already underway, with world-class sites and a number of the nation’s leading breast surgeons identified to participate in Perimeter’s pivotal study, which we anticipate initiating in mid-November at our first site at West Cancer Center’s Breast Center in Germantown, Tennessee under the direction of Dr. Richard E. Fine. Our hope is that the data generated from this trial supports our belief that Perimeter’s innovative OCT imaging technology will become a trusted tool for surgeons, resulting in better patient outcomes and lower healthcare costs."

Dr. Alastair Thompson, Principal Investigator and Professor, Section Chief of Breast Surgery and Olga Keith Wiess Chair of Surgery at Baylor College of Medicine and the Dan L Duncan Comprehensive Cancer Center said, "Currently, approximately one in four women who undergo breast conservation surgery require reoperation if their surgeon fails to get ‘clear’ margins. The goal of this pivotal study is to compare the use of Perimeter B-Series imaging technology with artificial intelligence against the standard of care and determine if it can improve surgeon’s ability to reduce re-operation rates for breast conservation surgery. Importantly, Perimeter’s novel imaging technology with AI fits into the routine surgical process with no additional imposition to the patient as it examines a tissue sample that is already being extracted. There is a strong medical need for tools to help surgeons identify if we have adequately removed the cancerous tissue real-time in the operating room and get it right the first time."

Dr. Richard E. Fine, Director of Education & Research, Margaret West Comprehensive Breast Center, West Cancer Center & Research Institute, commented, "I believe combining optical coherence tomography with artificial intelligence could represent the ‘next generation’ technology in specimen imaging. As breast cancer surgeons, we understand the physical, emotional, and financial stressors for patients that can come with needing a second surgery. The results from this study will not only help determine if this tool can assist physicians with improving patient outcomes but could also provide evidence of reducing the burden of additional costs within the overall healthcare system."

About Perimeter S-Series OCT

Cleared by the U.S. FDA, Perimeter S-Series Optical Coherence Tomography (OCT) is a novel medical imaging system that provides clinicians with cross-sectional, real-time margin visualization (1-2 mm below the surface) of an excised tissue specimen. Giving physicians the ability to visualize microscopic tissue structures "real time" in the operating room has the potential to result in better long-term outcomes for patients and lower costs to the healthcare system.

About Perimeter B-Series OCT with ImgAssist AI

Perimeter is advancing the development of its proprietary, next-gen "ImgAssist" artificial intelligence technology under its ATLAS AI project, which is made possible, in part, by a US$7.4 million grant awarded by the Cancer Prevention and Research Institute of Texas (CPRIT). The U.S. FDA granted Breakthrough Device Designation for Perimeter B-Series OCT coupled with ImgAssist AI, and Perimeter is conducting a randomized, multi-site, pivotal study to evaluate it against the current standard of care and assess the impact on re-operation rates for patients undergoing breast conservation surgery.