Market Newsdesk

DURHAM, N.C., Oct. 10, 2023 (GLOBE NEWSWIRE) — Fortrea (Nasdaq: FTRE), a leading global contract research organization (CRO), today announced that its Global Chief Information Security Officer (CISO), Jim Cameli, has been named to HotTopics’ Global CISO 100 2023.

“We are deeply fortunate to have Jim Cameli as a colleague and a leader, and are very pleased to see him get the recognition he rightly deserves,” said Fortrea’s Chief Information Officer, Alejandro Martinez. “Jim brought deep expertise and insight to Fortrea. He is a practical visionary, combining thought leadership and hands-on implementation. He has a history of giving back to practitioners in this relatively new field. Jim was a founding member and the first board president for the Retail and Hospitality Intelligence Sharing and Analysis Center (RH-ISAC). He served as a co-chair and governing body member for the Chicago CISO Executive Summit and is both CISSP and CRISC certified. We’re proud to have him at Fortrea.”

The Global CISO 100 award places Cameli alongside top executives in the cybersecurity space who have illustrated exceptional leadership and contributions to the field. To be named on this exclusive list, a panel of five industry judges compared Cameli’s efforts to a matrix of factors including:

• Building a company-wide security strategy that mitigates risk and maximizes business performance
• Leading by example, and championing diversity and inclusivity as the baseline of business
• Overseeing disruptive change under transformation and/or remote working
• Championing a culture of security internally
• A known thought leader, representing the sector on current and future state cybersecurity topics

“In today’s dynamic digital landscape, the role of a CISO is paramount. HotTopics is honored to spotlight the Global CISO 100 award for 2023, in partnership with CrowdStrike. Nominated by our extensive community of 17,000 executives and meticulously chosen by our independent judges, these pioneers are leading the cybersecurity frontier,” said Philip Randerson CEO & founder, of HotTopics. “My heartfelt congratulations to all our winners. Your unwavering commitment is shaping a safer digital future.”        

About Fortrea

Fortrea (Nasdaq: FTRE) is a leading global provider of clinical development and patient access solutions to the life sciences industry. We partner with emerging and large biopharmaceutical, medical device and diagnostic companies to drive healthcare innovation that accelerates life changing therapies to patients in need. Fortrea provides phase I-IV clinical trial management, clinical pharmacology, differentiated technology enabled trial solutions and post-approval services.

Fortrea’s solutions leverage three decades of experience spanning more than 20 therapeutic areas, a passion for scientific rigor, exceptional insights and a strong investigator site network. Our talented and diverse team of more than 19,000 people working in more than 90 countries is scaled to deliver focused and agile solutions to customers globally.

Learn more about how Fortrea is becoming a transformative force from pipeline to patient at Fortrea.com and follow us on LinkedIn and X (formerly Twitter) @Fortrea.

About HotTopics

Our company’s story is rooted in a vision for a more connected and inspired C-suite leadership. Our founder, Philip Randerson, spent over two decades at the helm of numerous leading technology executive search firms. Throughout his journey, he observed a growing disconnect among C-suite leaders, prompting him to leverage his vast network of influential executives to establish a global community that fosters collaboration, innovation, and the development of future leaders. Launched with the support of our esteemed Chairman, Jim Spanfeller, the former CEO of Forbes, and Kevin Eyres the former CEO of LinkedIn Europe, our company began as a series of six annual events spanning the United States and Europe. Today, our community has expanded to include over 17,000 C-suite leaders, with 75% of the Fortune 500 counted among our distinguished members.

Fortrea Contacts:

Fortrea Media: Sue Zaranek – 919-943-5422, [email protected]
Fortrea Media: Kate Dillon – 646-818-9115, [email protected]

CALGARY, Alberta, Oct. 10, 2023 (GLOBE NEWSWIRE) — Enerflex Ltd. (TSX: EFX) (NYSE: EFXT) (“Enerflex” or the “Company”) today announced the appointment of Mr. Preet Dhindsa as Interim Chief Financial Officer (“CFO”), effective October 13, 2023. Enerflex has retained an executive search firm and will consider Mr. Dhindsa and other candidates as part of its process to identify the Company’s next permanent CFO.

Mr. Dhindsa is a seasoned financial leader with more than 25 years of experience, primarily in the energy and financial services sectors. He most recently served as Executive Vice President and CFO at ENMAX Corporation, a regulated utility with energy generation and retail lines of business, where he was responsible for the finance and information technology organization across operations in both Canada and the United States. He previously served as CFO and Chief Administrative Officer at AMP Energy, a solar energy developer with a global footprint. Prior to that, Mr. Dhindsa was CFO, Global Banking & Markets at Scotiabank, where he managed a global finance team and critical regulatory relationships in Canada, the United States, Europe, and Asia-Pacific. Mr. Dhindsa began his career as an accountant at KPMG and Ernst & Young. He holds a Bachelor of Science degree in Mathematics and Statistics from Western University and a Graduate Diploma in Accounting from Wilfrid Laurier University. Mr. Dhindsa is a Chartered Accountant and Chartered Director.

“Preet has the right qualifications and experience to step into the role of Interim CFO, and we are excited to welcome him to Enerflex and benefit from his expertise at this important time for our company,” said Marc Rossiter, Enerflex’s President and Chief Executive Officer. “Preet brings a proven track record of leading large, international finance organizations, including through post-merger integration activities. He brings deep knowledge of the energy industry, capital markets, and investor relations to Enerflex’s already strong finance organization. I am confident that Preet’s experience leading diverse, complex, multi-national businesses, coupled with his financial acumen and accounting expertise, will serve Enerflex well and accelerate our efforts to unlock the value of the Exterran acquisition.”

Mr. Rossiter added, “Our business remains strong, and we look forward to providing an update on our financial results with our third-quarter 2023 earnings announcement. The Board of Directors and management team remain committed to executing on our strategy to deliver strong operational and financial performance and drive value creation for shareholders. To that end, we are actively working to improve Enerflex’s overall capacity for free cash flow generation to reduce debt by capturing synergies from the Exterran acquisition and enhancing operational efficiencies. We are confident Preet’s deep experience will help accelerate the achievement of our financial and strategic objectives, allowing us to deliver on Enerflex’s full potential for the benefit of our shareholders, customers, and other stakeholders.”

The Company will provide its full financial results and details regarding its progress on its strategic priorities in connection with its third-quarter 2023 earnings announcement in early November.

ADVISORY REGARDING FORWARD-LOOKING INFORMATION

This news release contains forward-looking information within the meaning of applicable Canadian securities laws and forward-looking statements within the meaning of the safe harbor provisions of the US Private Securities Litigation Reform Act of 1995. These statements relate to Management’s expectations about future events, results of operations, the future performance (both financial and operational) and business prospects of Enerflex, and other matters that may occur in the future. The use of any of the words “anticipate”, “future”, “plan”, “contemplate”, “create”, “continue”, “estimate”, “expect”, “intend”, “propose”, “might”, “may”, “will”, “shall”, “project”, “should”, “could”, “would”, “believe”, “predict”, “forecast”, “pursue”, “potential”, “objective”, “capable”, and similar expressions, are intended to identify forward-looking information. In particular, this news release includes (without limitation) forward-looking information pertaining to the Company’s expectations regarding performance in respect of certain financial and strategic objectives, including free cash flow generation and debt reduction through the capture of synergies from the Exterran acquisition and the timing associated therewith.

All forward-looking information in this news release is subject to important risks, uncertainties, and assumptions, which are difficult to predict, and which may affect Enerflex’s operations. While Enerflex believes that there is a reasonable basis for the forward-looking information included in this news release, as a result of such known and unknown risks, uncertainties, and other factors, actual results, performance, or achievements could differ and such differences could be material from those expressed in, or implied by, these statements. The forward-looking information included in this news release should not be unduly relied upon as a number of factors could cause actual results to differ materially from the results discussed in these forward-looking statements. The forward-looking information included in this news release is made as of the date of this news release and is based only on the information available to the Company at such time. Other than as required by law, Enerflex disclaims any intention or obligation to update or revise any forward-looking information, whether as a result of new information, future events, or otherwise. This news release and its contents should not be construed, under any circumstances, as investment, tax, or legal advice.

ABOUT ENERFLEX

Transforming Energy for a Sustainable Future. Enerflex is a premier integrated global provider of energy infrastructure and energy transition solutions, delivering natural gas processing, compression, power generation, refrigeration, cryogenic, and produced water solutions.

Headquartered in Calgary, Alberta, Canada, Enerflex, its subsidiaries, and interests in associates and joint ventures, operate in over 90 locations in: Canada, the United States, Argentina, Bolivia, Brazil, Colombia, Ecuador, Mexico, Peru, the United Kingdom, the Netherlands, the United Arab Emirates, Bahrain, Oman, Egypt, Kuwait, India, Iraq, Nigeria, Pakistan, Saudi Arabia, Australia, Indonesia, and Thailand.

Enerflex’s common shares trade on the Toronto Stock Exchange under the symbol “EFX” and on the New York Stock Exchange under the symbol “EFXT”. For more information about Enerflex, visit www.enerflex.com.

For investor and media enquiries, contact:

Marc Rossiter
President and Chief Executive Officer
E-mail: [email protected]

Martha Wilmot
Investor Relations
E-mail: [email protected]

Singapore, Oct. 10, 2023 (GLOBE NEWSWIRE) — Nova Vision Acquisition Corp. (NASDAQ: NOVV, the “Company”), a special purpose acquisition company, announced today that Nova Pulsar Holdings Limited, the Company’s initial public offering sponsor (“Sponsor”), has deposited into the Company’s trust account (the “Trust Account”) an aggregate of $69,763.37 (representing approximately $0.045 per ordinary share issued at the Company’s initial public offering that has not been redeemed), in order to extend the period of time the Company has to complete a business combination for an additional one (1) month period, from October 10, 2023 to November 10, 2023. The Company issued a promissory note to Sponsor with a principal amount equal to the amount deposited. The promissory note bears no interest and is convertible into the Company’s units (with each unit consisting of one ordinary share, one warrant to purchase one-half of one ordinary share, and one right to receive one-tenth of one ordinary share upon the consummation of the Company’s initial business combination) at a price of $10.00 per unit at the closing of a business combination by the Company. The purpose of the extension is to provide time for the Company to complete a business combination.

About Nova Vision Acquisition Corp.

Nova Vision Acquisition Corp. is a blank check company formed for the purpose of effecting a merger, share exchange, asset acquisition, share purchase, reorganization or similar business combination with one or more businesses. Nova Vision Acquisition Corp. anticipates target companies that focus in the fintech, proptech, consumertech, and supply chain management industries or technology companies that serve these or other sectors.

Forward Looking Statements

This press release includes forward-looking statements that involve risks and uncertainties. Forward looking statements are statements that are not historical facts. Such forward-looking statements, including the successful consummation of the Company’s initial public offering, are subject to risks and uncertainties, which could cause actual results to differ from the forward looking statements. The Company 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 the Company’s expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based.

Contact:
Nova Vision Acquisition Corp.
Investor Relations
[email protected]

NEW YORK, Oct. 10, 2023 (GLOBE NEWSWIRE) — Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced that it will report its financial results for the third quarter of 2023 on Monday, Nov. 6, 2023, before the opening of the U.S. financial markets. Axsome’s management team will host a conference call at 8:00 a.m. Eastern Time on Nov. 6, 2023, to discuss these results and provide a business update.

To participate in the live conference call, please dial (877) 405-1239 (toll-free domestic). A live webcast of the conference call can be accessed on the “Webcasts & Presentations” page of the “Investors” section of the Company’s website at www.axsome.com. A recording of the conference call will be available on the Company’s website for approximately 30 days following the live event.

About Axsome Therapeutics, Inc.

Axsome Therapeutics, Inc. is a biopharmaceutical company developing and delivering novel therapies for central nervous system (CNS) conditions that have limited treatment options. Through development of therapeutic options with novel mechanisms of action, we are transforming the approach to treating CNS conditions. At Axsome, we are committed to developing products that meaningfully improve the lives of patients and provide new therapeutic options for physicians. For more information, please visit the Company’s website at axsome.com. The Company may occasionally disseminate material, nonpublic information on the company website.

Forward Looking Statements

Certain matters discussed in this press release are “forward-looking statements”. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company’s statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the continued commercial success of our Sunosi^® and Auvelity^® products and the success of our efforts to obtain any additional indication(s) with respect to solriamfetol and/or AXS-05; the success, timing and cost of our ongoing clinical trials and anticipated clinical trials for our current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected revenues or expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of our ongoing clinical trials, and/or data readouts, and the number or type of studies or nature of results necessary to support the filing of a new drug application (“NDA”) for any of our current product candidates; our ability to fund additional clinical trials to continue the advancement of our product candidates; the timing of and our ability to obtain and maintain U.S. Food and Drug Administration (“FDA”) or other regulatory authority approval of, or other action with respect to, our product candidates, including statements regarding the timing of any NDA submission; whether issues identified by FDA in the complete response letter may impact the potential approvability of the Company’s NDA for AXS-07 for the acute treatment of migraine in adults with or without aura, pursuant to our special protocol assessment for the MOMENTUM clinical trial; the Company’s ability to successfully defend its intellectual property or obtain the necessary licenses at a cost acceptable to the Company, if at all; the successful implementation of the Company’s research and development programs and collaborations; the success of the Company’s license agreements; the acceptance by the market of the Company’s products and product candidates, if approved; the Company’s anticipated capital requirements, including the amount of capital required for the continued commercialization of Sunosi and Auvelity and for the Company’s commercial launch of its other product candidates, if approved, and the potential impact on the Company’s anticipated cash runway; unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19; and other factors, including general economic conditions and regulatory developments, not within the Company’s control. The factors discussed herein could cause actual results and developments to be materially different from those expressed in or implied by such statements. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstance.

Axsome Contacts:

Investors:
Mark Jacobson
Chief Operating Officer
Axsome Therapeutics, Inc.
One World Trade Center, 22^nd Floor
New York, NY 10007
Tel: 212-332-3243
Email: [email protected]
www.axsome.com

Media:

Darren Opland
Director, Corporate Communications
Axsome Therapeutics, Inc.
One World Trade Center, 22^nd Floor
New York, NY 10007
Tel: 929-837-1065
Email: [email protected]
www.axsome.com

Median overall survival of 13.6 months with BXCL701 +
KEYTRUDA
®
(
pembrolizumab), compared to 7.6 months with checkpoint inhibitor monotherapy (CPI) in late-line refractory patients in separate, Phase 2 trial

¹

56% of studied patients alive at one year following treatment with BXCL701 +
KEYTRUDA
®, compared to ~33% with
checkpoint inhibitor monotherapy (CPI) in late-line refractory patients in separate, Phase 2 trial

¹

Results support potential development in small cell lung cancer (SCLC) and other neuroendocrine tumors

Company to host conference call and webcast today at 8:00 a.m. ET

NEW HAVEN, Conn., Oct. 10, 2023 (GLOBE NEWSWIRE) — BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology, today announced positive overall survival (OS) data from its Phase 2 trial of BXCL701, the Company’s investigational oral innate immune activator, in combination with KEYTRUDA^® (pembrolizumab) in patients with small cell neuroendocrine prostate cancer (SCNC). As of a data cutoff of September 6, 2023, evaluable patients with SCNC (n=28) showed a median OS of 13.6 months (95% CI 10.9–NR), and a 12-month survival rate of 56.5%.

“OS is the most meaningful measure by which the effectiveness of an oncology treatment is evaluated. Though these results are based on a non-randomized cohort of patients, observing a median OS of this duration including patients with long-term survival at 12 months and beyond shows exceptional promise, bearing in mind historic data with checkpoint inhibitor monotherapy in this high-risk subset of prostate cancer,” said Rahul Aggarwal, M.D., Principal Investigator, Associate Director for Clinical Sciences, Helen Diller Family Comprehensive Cancer Center, and Professor of Medicine at the University of California San Francisco (UCSF). “SCNC represents a major unmet medical need, with the majority of patients unfortunately succumbing to their disease in less than one year following chemotherapy. The results of this trial suggest that BXCL701 has the potential to extend the lives of patients, and I look forward to its continued clinical development.”

SCNC, classified as a “cold” tumor, represents an underserved, growing patient population, with cases increasing due to earlier and more widespread use of androgen receptor inhibitors. In 2023, there will be an estimated 288,300² new patients with prostate cancer in the United States, with approximately 11,532 patients progressing to SCNC.

“We believe our trial results are highly encouraging for patients with this disease and have potential implications for our evaluation of BXCL701 for the treatment of other high-grade neuroendocrine tumors, such as small cell lung cancer, where effective therapies are lacking,” said Vincent J. O’Neill, M.D., Chief R&D Officer, OnkosXcel Therapeutics, a wholly owned subsidiary of BioXcel Therapeutics. “We intend to discuss these data with the FDA to help determine our next steps with clinical development.”

The Phase 2 trial is an open-label, multicenter study to evaluate the safety and efficacy of BXCL701 in combination with pembrolizumab in men with SCNC. Twenty-eight (28) evaluable SCNC patients received 0.3 mg of BXCL701 twice daily (BID) on days 1 through 14 of a 21-day cycle (0.2 mg BID the first week of cycle 1) plus 200 mg of pembrolizumab administered intravenously on day 1 and every subsequent 21 days. The primary objective of the trial is a composite response rate defined as either objective response by RECIST 1.1 criteria and/or PSA₅₀ and/or CTC count conversion.
Secondary objectives include duration of response, progression-free survival, overall survival, and biomarker evaluation as measured by changes in circulating cytokines and correlation of outcome with baseline tumor characteristics.

The Company is continuing to actively evaluate strategic options for OnkosXcel Therapeutics, including potential financing, strategic partnership, or M&A.

Conference Call
BioXcel Therapeutics will host a conference call and webcast on October 10, 2023 at 8:00 a.m. ET to discuss the data results from the Phase 2 trial of BXCL701. To access the call, please dial 877-407-5795 (domestic) or 201-689-8722 (international). A live webcast and presentation materials will be available on the Investors section of the corporate website, bioxceltherapeutics.com, and a webcast replay will be available through January 10, 2024.

BioXcel Therapeutics may use its website as a distribution channel of material information about the Company. Financial and other important information is routinely posted on and accessible through the Investors sections of its website at www.bioxceltherapeutics.com. In addition, you may sign up to automatically receive email alerts and other information about the Company by visiting the “Email Alerts” option under the News/Events section of the Investors & Media website section and submitting your email address.

About Metastatic Castration-Resistant Prostate Cancer (mCRPC) and Treatment-Emergent Small Cell Neuroendocrine Prostate Cancer (SCNC)

mCRPC is a form of advanced prostate cancer that is no longer responding to testosterone-lowering hormone treatments and has spread to other areas of the body such as the lymph nodes, bones, bladder, rectum, liver, or lungs. Treatment-emergent SCNC is a particularly difficult-to-treat histologic subtype of mCRPC that emerges in approximately 20% of mCRPC patients, though this number is increasing due to earlier and more widespread use of androgen blockers.

About OnkosXcel Therapeutics, LLC and BXCL701

OnkosXcel Therapeutics, LLC is a wholly owned subsidiary of BioXcel Therapeutics, Inc., focused on developing transformative medicines in oncology utilizing artificial intelligence. The subsidiary was formed in 2022 to develop BXCL701.

BXCL701 is an investigational, oral innate immune activator designed to initiate inflammation in the tumor microenvironment. Approved and experimental immunotherapies often fail to address cancers that appear “cold.” Therefore, BXCL701 is being evaluated to determine if it can render “cold” tumors “hot,” making them more detectable by the adaptive immune system and thereby facilitating the development of a strong anti-cancer immune response. OnkosXcel Therapeutics’ preclinical data support BXCL701’s potential synergy with both current checkpoint inhibitors and emerging immunotherapies directed to activate T-cells. BXCL701 is currently being developed as a potential therapy for the treatment of aggressive forms of prostate cancer and advanced solid tumors that are refractory or treatment naïve to checkpoint inhibitors. BXCL701 has received Orphan Drug Designation from the U.S. Food & Drug Administration (FDA) in four indications: acute myelogenous leukemia, pancreatic cancer, stage IIb to IV melanoma, and soft tissue sarcoma. An approximately 800-subject clinical database, with data collected by the Company and others, supports the ongoing development of BXCL701.

About BioXcel Therapeutics, Inc.
BioXcel Therapeutics, Inc. (Nasdaq: BTAI) is a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology. The Company’s drug re-innovation approach leverages existing approved drugs and/or clinically validated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indications. For more information, please visit bioxceltherapeutics.com.

Forward-Looking Statements
This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All statements contained in this press release other than statements of historical fact should be considered forward-looking statements, including, without limitation, statements regarding: the Company’s expected timing of, trial design and data results from, future clinical trials of BXCL701 with pembrolizumab, potential benefits from treatment with BXCL701, the Company’s planned discussions with FDA, the Company’s plans to evaluate strategic options for OnkosXcel Therapeutics and potential market size and opportunity for product candidates. The words “anticipate,” “believe,” “can,” “continue,” “could,” “designed,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements use these words or expressions. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward- looking. All forward-looking statements are based upon the Company’s current expectations and various assumptions. The Company believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. The Company may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, its limited operating history; its incurrence of significant losses; its need for substantial additional funding and ability to raise capital when needed; its ability to successfully negotiate amended terms under the financing agreements to be able to access funding and to obtain relief under financial covenants; its significant indebtedness and potential payment obligations related to such indebtedness and other contractual obligations; risks associated with the strategic reprioritization; its limited experience in drug discovery and drug development; risks related to the TRANQUILITY II Phase 3 trial and related audit; its dependence on the success and commercialization of IGALMI™, BXCL501, BXCL502 BXCL701 and BXCL702 and other product candidates; its lack of experience in marketing and selling drug products; the risk that IGALMI or the Company’s product candidates may not be accepted by physicians or the medical community in general; the failure of preliminary data from its clinical studies to predict final study results; failure of its early clinical studies or preclinical studies to predict future clinical studies; its ability to receive regulatory approval for its product candidates; its ability to enroll patients in its clinical trials; undesirable side effects caused by the Company’s product candidates; its novel approach to the discovery and development of product candidates based on EvolverAI; the significant influence of and dependence on BioXcel LLC; its exposure to patent infringement lawsuits; its reliance on third parties; its ability to comply with the extensive regulations applicable to it; impacts from data breaches or cyber-attacks, if any; impacts from the COVID-19 pandemic; risks associated with the increased scrutiny relating to environmental, social and governance (ESG) matters; its ability to commercialize its product candidates; and the other important factors discussed under the caption “Risk Factors” in its Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2023, which are accessible on the SEC’s website at www.sec.gov. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While the Company may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this press release.

Contact Information

Corporate

BioXcel Therapeutics
Erik Kopp
1.203.494.7062
[email protected]

Investor Relations

BioXcel Therapeutics
Brennan Doyle
1.475.355.8462
[email protected]

Media

Russo Partners
Scott Stachowiak
1-646-942-5630
[email protected]

Source: BioXcel Therapeutics, Inc.

IGALMI™ is a trademark of BioXcel Therapeutics, Inc. 
BT BIOXCEL THERAPEUTICS is a registered trademark of BioXcel Therapeutics, Inc.
All other trademarks are the properties of their respective owners. 
Copyright © 2023, BioXcel Therapeutics, Inc. All rights reserved. 

¹ FOR ILLUSTRATIVE PURPOSES ONLY: Analysis based on results from avelumab PICK-NEPC study. Landon C. Brown et al. Prostate Cancer and Prostatic Diseases; https://doi.org/10.1038/s41391-022-00524-7. No head-to-head clinical trial has been conducted evaluating BXCL701 against avelumab or other candidates or products. Notable differences exist between the Company’s trial designs, conditions under study and subject characteristics as compared to the evaluated third-party Phase 2 results discussed above and caution should be exercised when comparing data across these studies. One year survival rate extrapolated by the Company using Kaplan-Meier estimates of overall survival curve from the PICK-NEPC study. Please see the “Appendix” of the presentation materials for the conference call being held today, October 9, 2023, for information regarding the differences between the clinical trials.

² American Cancer Society. Key Statistics for Prostate Cancer. Retrieved October 9, 2023. https://www.cancer.org/cancer/types/prostate-cancer/about/key-statistics.html#:~:text=The%20American%20Cancer%20Society’s%20estimates,34%2C700%20deaths%20from%20prostate%20cancer

Cohort 4 of the ReSPECT-LM Phase 1 dose escalation trial is the first of 4 planned cohorts in Part B; the Company anticipates moving into Cohort 5 following standard safety review

Updates on the ReSPECT-LM trial and on the ReSPECT-GBM trials in recurrent glioblastoma are planned for November 15-19 at the Society for Neuro-Oncology Annual Meeting

AUSTIN, Texas, Oct. 10, 2023 (GLOBE NEWSWIRE) — Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today announced it has completed dosing in Cohort 4 of the ReSPECT-LM Phase 1/2a dose escalation clinical trial of rhenium (¹⁸⁶Re) obisbemeda for the treatment of leptomeningeal metastases (LM) from solid tumors. In addition, the Company has completed the transfer of proprietary materials, protocols, and equipment from Biocept under the terms of the recently announced expanded agreement for CNSide, a cerebrospinal fluid (CSF)-based tumor cell capture and enumeration assay being utilized in the ReSPECT-LM clinical trial.

“The speed at which we are enrolling in the ReSPECT-LM trial reflects multiple factors, including the increasing number of patients diagnosed with LM, the lack of good therapeutic options and growing enthusiasm for the trial,” said Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics. “Furthermore, significant updates on both the ReSPECT-LM and ReSPECT-GBM studies are planned for November 15-19, 2023 at the Society for Neuro-Oncology (SNO) Annual Meeting.”

Phase 1, Part A of the ReSPECT-LM trial (Cohorts 1-3) is complete and demonstrated an average 53% reduction in CNSide tumor cell counts at Day 28 post-treatment in 10 patients receiving a single administration of rhenium (¹⁸⁶Re) obisbemeda. The FDA has approved continued dose escalation and expansion into Part B (Cohorts 4-7). Completion of dosing in Cohort 4 was the fastest enrollment of all the Cohorts to date. There have been no observed dose limiting toxicities with radiation doses of up to 44.10 millicuries. The Company plans to initiate dosing in Cohort 5 this quarter, pending Data Safety Monitoring Board (DSMB) approval. After the update at the SNO meeting in November, the Company anticipates additional data releases in 2024.

The CNSide assay has potential as: an LM diagnostic assay, a surrogate endpoint in clinical trials for CNS cancers such as LM, and as a disease monitoring biomarker assay in the management of patients undergoing radiotherapy for LM. The acquired materials and protocols from Biocept help ensure Plus’ access to the CNSide assay in the ongoing ReSPECT-LM Phase 1 clinical trial with rhenium (¹⁸⁶Re) obisbemeda. Plus Therapeutics retains its option, solely at the Company’s discretion, to acquire an exclusive field of use license on the CNSide assay in return for a $1.0 million payment, if exercised prior to January 1, 2025.

The FDA has granted Fast Track designation to rhenium (¹⁸⁶Re) obisbemeda for the treatment of LM, and the ReSPECT-LM Phase 1 program continues to be funded in part by a 3-year $17.6 million grant from the Cancer Prevention & Research Institute of Texas (CPRIT). Patients interested in learning more about the ReSPECT-LM trial can visit ClinicalTrials.gov (NCT05034497).

About Leptomeningeal Metastases (LM)
LM is a rare complication of cancer in which the primary cancer spreads to the cerebrospinal fluid (CSF) and leptomeninges surrounding the brain and spinal cord. All malignancies originating from solid tumors, primary brain tumors, or hematological malignancies have this LM complication potential with breast cancer as the most common cancer linked to LM, with 3-5% of breast cancer patients developing LM. Additionally, lung cancer, GI cancers and melanoma can also spread to the CSF and result in LM. LM occurs in approximately 5% of people with cancer and is usually terminal with 1-year and 2-year survival of just 7% and 3%, respectively. The incidence of LM is on the rise, partly because cancer patients are living longer and partly because many standard chemotherapies cannot reach sufficient concentrations in the spinal fluid to kill the tumor cells, yet there are no FDA-approved therapies specifically for LM patients, who often succumb to this complication within weeks to several months, if untreated.

About Rhenium (
¹⁸⁶
Re) obisbemeda 

Rhenium (¹⁸⁶Re) obisbemeda is a novel injectable radiotherapy specifically formulated to deliver highly targeted high dose radiation in CNS tumors in a safe, effective and convenient manner to optimize patient outcomes. Rhenium (¹⁸⁶Re) obisbemeda has the potential to reduce risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue and gamma energy for live imaging. Rhenium (¹⁸⁶Re) obisbemeda is being evaluated for the treatment of recurrent glioblastoma and leptomeningeal metastases in the ReSPECT-GBM and ReSPECT-LM clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT).

About CNSide

CNSide is an assay based on proprietary quantitative tumor cell capture method paired with advanced digital imaging and molecular markers used to detect, characterize, and quantify tumor cells in CSF of patients with a variety of solid organ carcinomas and suspected LM, particularly breast and lung cancer which are leading causes of LM. CNSide provides a robust quantitative method to evaluate tumor status and response to treatment compared to conventional CSF cytology or radiologic monitoring.

In March 2023, Biocept initiated enrollment in the FORESEE trial with CNSide. The FORESEE trial is a two-part, multicenter, prospective clinical trial expected to enroll up to 40 patients with breast or non-small cell lung cancer who have suspicious or confirmed LM. The goal of the FORESEE trial is to evaluate the performance of CNSide in monitoring LM’s response to treatment and to assess the impact of CNSide on treatment decisions made by physicians. The feasibility phase of the study is expected to complete in the first half of 2024, which will be followed by a validation phase that is estimated to include between 40 and 100 subjects.

About Plus Therapeutics

Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a robust supply chain through strategic partnerships that enable the development, manufacturing and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.

¹

The CNSide assay is not an FDA cleared or approved assay. It is a Biocept lab developed test and its performance characteristics were determined in Biocept’s CLIA-certified, CAP-accredited laboratory.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “designed to,” “will,” “can,” “potential,” “focus,” “preparing,” “next steps,” “possibly,” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential promise of ¹⁸⁶Re including the ability of ¹⁸⁶Re to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-GBM and ReSPECT-LM clinical trials; possible negative effects of ¹⁸⁶Re; the continued evaluation of ¹⁸⁶Re including through evaluations in additional patient cohorts; and the intended functions of the Company’s platform and expected benefits from such functions.

The forward-looking statements included in this press release are subject to a number of risks and uncertainties that may cause actual results to differ materially from those discussed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the Company’s actual results may differ, including materially, from those anticipated in these forward-looking statements as a result of various factors, including, but not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field, among others; and additional risks described under the heading “Risk Factors” in the Company’s Securities and Exchange Commission filings, including in the Company’s annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.

Investor Contact

Corey Davis, Ph.D.
LifeSci Advisors
(212) 215-2577
[email protected]

BOCA RATON, Fla., Oct. 10, 2023 (GLOBE NEWSWIRE) — First Wave BioPharma, Inc., (NASDAQ: FWBI), (“First Wave BioPharma” or the “Company”), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today announced that Chairman, President, and CEO of First Wave BioPharma James Sapirstein’s presentation at the 2023 BIO Investor Forum will take place at 11:15 a.m. PDT on October 17, 2023 in the Franciscan B Room at the Hilton San Francisco.

In addition to the presentation, members of the First Wave BioPharma management team will conduct one-on-one meetings with registered investors at the conference, showcasing the company’s business and clinical development strategy, recent corporate achievements, and anticipated milestones.

Details of the presentation are as follows:

Event:	2023 BIO Investor Forum
Presentation:	First Wave BioPharma Company Overview and Updates – Chairman, President, and CEO James Sapirstein
Date/Time:	Tuesday, October 17, 2023; 11:15 a.m. PDT
Location:	The Hilton San Francisco, 333 O’Farrell Street, San Francisco, CA The Franciscan B Room

About First Wave BioPharma, Inc.

First Wave BioPharma is a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases. The Company is currently advancing a therapeutic development pipeline with multiple Phase 2 clinical stage programs built around three proprietary technologies – the biologic adrulipase, a recombinant lipase enzyme designed to enable the digestion of fats and other nutrients in cystic fibrosis and chronic pancreatitis patients with exocrine pancreatic insufficiency; capeserod, a selective 5-HT4 receptor partial agonist which First Wave will pursue for gastrointestinal (GI) indications; and niclosamide, an oral small molecule with anti-inflammatory properties for patients with inflammatory bowel diseases such as ulcerative colitis and Crohn’s disease. First Wave BioPharma is headquartered in Boca Raton, Florida. For more information visit www.firstwavebio.com.

For more information:

First Wave BioPharma, Inc.
777 Yamato Road, Suite 502
Boca Raton, FL 33431
Phone: (561) 589-7020
[email protected]

Media contact:

Tiberend Strategic Advisors, Inc.

David Schemelia
(609) 468-9325
[email protected]

WILMETTE, Ill., Oct. 10, 2023 (GLOBE NEWSWIRE) — Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing innovative treatments for cancer patients, today announced that Andrew J. Cittadine, Monopar’s Chief Operating Officer, will present at the Roth MKM 2023 Healthcare Opportunities Conference.

Presentation Details:

Date: October 12, 2023
Time: 12:15 p.m. (ET)
Location: The Yale Club, New York City, New York

https://www.roth.com/conferences/upcoming-conferences

About Monopar Therapeutics Inc.

Monopar Therapeutics is a clinical-stage biopharmaceutical company focused on developing innovative treatments for cancer patients. Monopar’s pipeline consists of camsirubicin (Phase 1b) for the treatment of advanced soft tissue sarcoma; MNPR-101, a late-stage preclinical antibody for radiopharmaceutical use in advanced cancers; and MNPR-202, an early-stage camsirubicin analog for various cancers. For more information, visit: www.monopartx.com.

CONTACT:

Monopar Therapeutics Inc.

Investor Relations
Kim R. Tsuchimoto
Chief Financial Officer
[email protected]

Follow Monopar on social media for updates:
Twitter: @MonoparTx LinkedIn: Monopar Therapeutics

 

Amended clinical collaboration and supply agreement increases the palazestrant/ribociclib combination Phase 1/2 clinical study size to approximately 60 patients

Expanded study supports the potential late-stage development of palazestrant in first-line advanced or metastatic breast cancer in combination with ribociclib

SAN FRANCISCO, Oct. 10, 2023 (GLOBE NEWSWIRE) — Olema Pharmaceuticals, Inc. (“Olema” or “Olema Oncology,” Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women’s cancers, today announced an amendment to our existing clinical collaboration and supply agreement with Novartis Institutes for BioMedical Research, Inc. (“Novartis”) to increase the size of the ongoing Phase 1/2 clinical study testing palazestrant in combination with ribociclib to approximately 60 patients.

“The amendment announced today significantly increases the size of our ongoing Phase 1/2 clinical study testing palazestrant in combination with ribociclib, in collaboration with Novartis,” said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. “With the Phase 1b dose escalation portion now successfully completed, we are currently in Phase 2 dose expansion at the 120 mg dose of palazestrant in combination with 600 mg of ribociclib. We believe that this expanded study now has the potential to generate a clinical dataset sufficient to support the regulatory pathway for a first-line pivotal trial.”

Olema first signed a clinical collaboration and supply agreement with Novartis in July 2020, the agreement was amended and restated in January 2022, and focuses on the evaluation of the safety, tolerability and efficacy of palazestrant in combination with Novartis’ proprietary cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor ribociclib and/or Novartis’ proprietary phosphatidylinositol 3-kinase (PI3Ka) inhibitor alpelisib in patients with metastatic ER+ breast cancer. The amendment adds approximately 30 patients to be enrolled in the cohort expansion phase of the palazestrant clinical study in combination with ribociclib.

About Olema Oncology

Olema Oncology is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women’s cancers. Olema’s lead product candidate, palazestrant (OP-1250), is a proprietary, orally-available small molecule with dual activity as both a complete estrogen receptor (ER) antagonist (CERAN) and a selective ER degrader (SERD). It is currently being evaluated both as a single agent in an ongoing Phase 2 clinical trial, and in combination with CDK4/6 inhibitors (palbociclib and ribociclib) and a PI3Ka inhibitor (alpelisib), in patients with recurrent, locally advanced or metastatic ER-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. Palazestrant has been granted FDA Fast Track designation for the treatment of ER+/HER2- metastatic breast cancer that has progressed following one or more lines of endocrine therapy with at least one line given in combination with a CDK4/6 inhibitor. Olema is headquartered in San Francisco and has operations in Cambridge, Massachusetts. For more information, please visit us at www.olema.com, or follow us on Twitter and LinkedIn.

Forward Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Words such as “anticipate,” “expect,” “will,” “may,” “goal,” “potential” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These statements include those related to the timelines for potential clinical trials of palazestrant (OP-1250) in combination trials, the potential impact and sufficiency of clinical trial results for clinical trial timelines for palazestrant in combination trials, palazestrant’s combinability with other drugs, patient enrollment, and statements regarding Olema’s partnerships and collaborations. Because such statements deal with future events and are based on Olema’s current expectations, they are subject to various risks and uncertainties, and actual results, performance or achievements of Olema could differ materially from those described in or implied by the statements in this press release. These forward-looking statements are subject to risks and uncertainties, including, without limitation, those discussed in the section titled “Risk Factors” in Olema’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2023, and future filings and reports that Olema makes from time to time with the U.S. Securities and Exchange Commission. Except as required by law, Olema assumes no obligation to update these forward-looking statements, including in the event that actual results differ materially from those anticipated in the forward-looking statements.

Contact:
Geoffrey Mogilner, Vice President, Investor Relations and Communications
[email protected]

EMERYVILLE, Calif., Oct. 10, 2023 (GLOBE NEWSWIRE) — Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company that aims to develop the world’s most potent vaccines, today announced that the Compensation Committee of the company’s Board of Directors granted three employees nonqualified stock options to purchase an aggregate of 47,000 shares of its common stock with an exercise price of $2.41, which is equal to the closing price of Gritstone’s common stock on October 5, 2023, the date of the grant. These stock options are part of an inducement material to the new employees becoming an employee of Gritstone, in accordance with Nasdaq Listing Rule 5635(c)(4).

The stock options will vest over a four-year period, with 25% of the options vesting on the first anniversary of the employees’ date of hire, and 1/48th of the options vesting monthly thereafter, subject to the employees’ continued employment with Gritstone on such vesting dates. The stock options are subject to the terms and conditions of Gritstone’s 2021 Employment Inducement Incentive Award Plan and the stock option agreement covering the grant.

About Gritstone bio

Gritstone bio, Inc. (Nasdaq: GRTS) is a clinical-stage biotechnology company that aims to develop the world’s most potent vaccines. We leverage our innovative vectors and payloads to train multiple arms of the immune system to attack critical disease targets. Independently and with our collaborators, we are advancing a portfolio of product candidates to treat and prevent viral diseases and solid tumors in pursuit of improving patient outcomes and eliminating disease. www.gritstonebio.com

Gritstone bio Contacts


Investors:
George E. MacDougall
Gritstone bio, Inc.
[email protected]

Media:
Dan Budwick
1AB
(973) 271-6085
[email protected]