On November 15, 2022 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13) reported a corporate and strategic update, following an in-depth evaluation of the business (Press release, Hutchison Medipharma, NOV 15, 2022, View Source [SID1234624103]).

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In response to the challenging market conditions currently affecting the global biopharmaceutical sector, HUTCHMED has taken a number of decisions aimed at accelerating HUTCHMED’s path to profitability and establishing a long-term sustainable business.

HUTCHMED is proactively making a strategic shift to focus on the most advanced assets from its internal developed pipeline, that are most likely to drive near-term value. Accordingly:

HUTCHMED will prioritize its late-stage and registrational studies, to focus on bringing these assets through regulatory approval in particular the global registration of fruquintinib.
Selected early-stage studies will not be prioritized for internal development, and others will be considered as candidates for out-licensing opportunities, enabling the company to focus resources on its later-stage assets. As some related clinical trials wind down, HUTCHMED remains committed to ethical practices and patient care will continue to be our top priority.
HUTCHMED will seek potential partnerships to commercialize its assets outside of China, to accelerate the availability of innovative medicines for patients globally.
HUTCHMED will provide updates in due course with detailed decisions regarding specific programs and progress to streamline the organization, redeploying key talent in support of registrational studies and regulatory submissions.

In light of this strategic shift in focus, Dr. Michael Shi, currently Executive Vice President, Head of Research and Development and Chief Medical Officer, China, will become responsible for clinical development globally. Under Dr. Shi’s leadership, HUTCHMED will remain highly focused on the regulatory submission and further development for fruquintinib, its lead international asset, following the successful multi-regional clinical trial results achieved in August 2022 from FRESCO-2, including its upcoming U.S. FDA New Drug Application filing. As part of this change in strategic focus, Dr. Marek Kania, Executive Vice President, Managing Director and Chief Medical Officer, International, will be transitioning out from his role with HUTCHMED.

Dr. Weiguo Su, Executive Director, Chief Executive Officer and Chief Scientific Officer of HUTCHMED, said:

"We believe that these prudent actions will ensure that we accelerate our path to profitability and therefore establish a sustainable business to support our future success. The challenging market conditions affecting biopharmaceutical companies across the globe require companies to be disciplined in their approach and, like many other companies, we have decided to make adjustments now to enable us to focus on the development of the products in our late-stage pipeline.

"On behalf of the Board and management team, I would like to recognize the contributions of everyone affected by our decisions and I remain grateful to our global team for their continued work towards HUTCHMED’s success. I would also like to thank Marek for his contribution to HUTCHMED, his role in establishing our presence internationally, and building a strong leadership team to accelerate the clinical development of several major programs.

"Our vision of becoming a global biopharmaceutical company remains unchanged, but we expect to fulfill this strategy by commercialization outside China primarily through partnerships. Regardless, we will continue to invest in global development to reach our goal of bringing innovative medicines to patients worldwide."

On November 15, 2022 Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, reported its financial results for the third quarter ended September 30, 2022 and provided an update on recent corporate developments (Press release, Bio-Path Holdings, NOV 15, 2022, View Source [SID1234624102]).

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"The third quarter was marked by continued progress across our entire DNAbilize pipeline. It was highlighted by the initiation of our Phase 1/1b study of BP1002 in refractory/relapsed acute myeloid leukemia patients," said Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings. "Looking to the remainder of the year and into 2023, we are well-positioned to maintain this momentum. We look forward to initiating our Phase 1 study of BP1001-A for the treatment of solid tumors later this year and to filing an Investigational New Drug (IND) application for BP1003, a novel liposome-incorporated STAT3 antisense oligodeoxynucleotide, in the first half of 2023."

Recent Corporate Highlights

●Announced First Patient Dosed in Phase 1/1b Study of BP1002 in Refractory/Relapsed Acute Myeloid Leukemia Patients. In October, Bio-Path announced the enrollment and dosing of the first patient in a Phase 1/1b clinical trial evaluating the ability of BP1002 to treat refractory/relapsed acute myeloid leukemia (AML) patients.

●Closed $2.0 Million Registered Direct Offering and Concurrent Private Placement. In November, Bio-Path entered into a definitive agreement with certain institutional investors for the issuance and sale of 800,000 shares of its common stock (or common stock equivalents) for a price of $2.50 per share, for gross proceeds of approximately $2.0 million, in a registered direct offering. Additionally, in a concurrent private placement, Bio-Path also agreed to issue to such investors unregistered warrants. The offerings closed on November 9, 2022.

Financial Results for the Third Quarter Ended September 30, 2022

●The Company reported a net loss of $3.5 million, or $0.49 per share, for the three months ended September 30, 2022, compared to a net loss of $2.1 million, or $0.29 per share, for the three months ended September 30, 2021.

●Research and development expense for the three months ended September 30, 2022 increased to $2.4 million, compared to $1.0 million for the three months ended September 30, 2021, primarily due to manufacturing expenses related to drug product releases in the third quarter of 2022 and start-up costs related to our Phase 1 clinical trial for BP1001-A in solid tumors.

●General and administrative expense for the three months ended September 30, 2022 was $1.2 million, an increase of $0.1 million compared to the three months ended September 30, 2021, primarily due to increased legal fees.

●As of September 30, 2022, the Company had cash of $13.7 million, compared to $23.8 million at December 31, 2021. Net cash used in operating activities for the nine months ended September 30, 2022 was $10.1 million compared to $7.1 million for the comparable period in 2021.

Conference Call and Webcast Information

Bio-Path Holdings will host a conference call and webcast today at 8:30 a.m. ET to review these third quarter 2022 financial results and to provide a general update on the Company. To access the conference call please dial (833) 630-1956 (domestic) or (412) 317-1837 (international). A live audio webcast of the call and the archived webcast will be available in the Media section of the Company’s website at www.biopathholdings.com.

On November 15, 2022 Sigyn Therapeutics, Inc. ("Sigyn" or the "Company") (OTCQB: SIGY), a development-stage company focused on creating therapeutic solutions to address unmet needs in global health, reported financial results for the third quarter ended September 30, 2022 and provides an update on recent corporate developments (Press release, Sigyn Therapeutics, NOV 15, 2022, View Source [SID1234624101]).

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"Among our third quarter and subsequent corporate developments, we commenced trading on the OTCQB Venture Exchange, established the lead treatment indication for Sigyn TherapyTM, strengthened our Board of Directors, expanded our intellectual property portfolio, and introduced a candidate therapeutic system to enhance the delivery of chemotherapy and reduce its toxicity in cancer patients," commented Jim Joyce, co-founder and CEO of Sigyn Therapeutics.

Third Quarter 2022 and Subsequent Developments

Commenced trading on the OTCQB Venture Exchange.
Announced plans to pursue first-in-human feasibility studies of Sigyn Therapy in End-Stage Renal Disease patients suffering from excess inflammation and/or endotoxemia.
Brought a diverse set of expertise to its Board of Directors by appointing Richa Nand, B.S., J.D.; Jim Dorst, B.S., M.S.; and Christopher Wetzel, B.S., M.B.A. as directors.
Filed a provisional patent application entitled: "SYSTEM AND METHODS TO ENHANCE CHEMOTHERAPY DELIVERY AND REDUCE TOXICITY" with the United States Patent and Trademark Office ("USPTO").
Related to the provisional patent application for its cancer treatment system, filed intent-to-use trademark applications to register ChemoPrep and ChemoPure with the USPTO.
Summary Third Quarter 2022 Financial Results

For the quarter ended September 30, 2022, the Company had a loss from operations of approximately $533,000, compared to an operating loss of approximately $573,000 for the comparable period of 2021. The Company’s net loss for the 2022 third quarter was approximately $727,000, or approximately $0.02 per share, compared to a net loss of approximately $666,000, or approximately $0.02 per share, for the comparable period in 2021. Third quarter 2022 net cash used in operating activities was approximately $524,000.

For complete financial results, please see Sigyn Therapeutics’ filings at www.sec.gov, and on the Company’s website at www.SigynTherapeutics.com under "Financial Info" in the Investors section.

On November 15, 2022 Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported that it has received preliminary approval for a tax credit from the New Jersey Economic Development Authority’s (NJEDA) New Jersey Technology Business Tax Certificate Transfer program (Press release, Soligenix, NOV 15, 2022, View Source [SID1234624100]). As a result, the Company anticipates being able to transfer this credit and receive approximately $1.2 million in net proceeds.

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"This is our thirteenth year receiving Net Operating Loss (NOL) funding," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix, "Over this time period, we have received nearly $9 million in non-dilutive NOL funding that has allowed us to advance and expand our rare disease pipeline. Before the end of this year, we will file our new drug application (NDA) with the U.S. Food and Drug Administration for HyBryte (synthetic hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL), as well as initiate a Phase 2a clinical study with SGX302 (synthetic hypericin) for the treatment of mild-to-moderate psoriasis."

Dr. Schaber continued, "As we are always looking for non-dilutive ways to fund our company, we are once again very pleased with NJEDA’s continued support of its biotechnology industry. With over $16 million in cash, not including our non-dilutive funding, we remain focused on advancing towards U.S. commercialization of HyBryte in CTCL where peak annual net sales are expected to exceed $90 million, with the total addressable worldwide market estimated at approximately $250 million annually."

This competitive NJEDA program enables approved technology and biotechnology businesses to sell their unused NOL Carryovers and unused Research and Development (R&D) Tax Credits to unaffiliated, profitable corporate taxpayers in the state of New Jersey. This allows businesses with NOLs to turn their tax losses and credits into cash proceeds to fund additional R&D, purchase equipment and/or facilities, or cover other allowable expenditures. The NJEDA determines eligibility for the program, the New Jersey Division of Taxation determines the value of the available tax benefits (NOLs and R&D Tax Credits), and the New Jersey Commission on Science and Technology evaluates the technology and its viability. The State of New Jersey was the originator of this program and the first state to implement and fund it.

On November 15, 2022 xCures reported that they will present two posters at the 27th Annual Meeting of the Society for Neuro-Oncology, from the 16th to the 20th of November 2022, in Tampa Bay, Florida (Press release, xCures, NOV 15, 2022, View Source [SID1234624099]).

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The Society for Neuro-Oncology is a multidisciplinary society of healthcare professionals dedicated to promoting advances in neuro-oncology through research and education. Their annual meeting features research and educational sessions on brain tumors, including the latest on diagnosis and treatments.

The two xCures posters will be presented at the Poster Session on Friday, November 18, 2022, from 7:30 pm-9:30 pm EST, and are entitled:

EPCO-10: Systems biology-based therapeutic predictions with gbmSYGNAL and clinical correlates in the real-world longitudinal outcomes registry XCELSIOR

Timothy J. Stuhlmiller, Serdar Turkarslan, Julie C. Friedland, Asher Wasserman, Jameson Quinn, Zac Cole, Alaa Awawda, Sabrina Irizarry, Sebastian Williams, Mark Shapiro, Santosh Kesari, Anoop P. Patel, Nitin S. Baliga

BIOS-03: Real world clinical outcomes of patients with diffuse midline glioma in a longitudinal outcomes registry

Timothy J. Stuhlmiller, Asher Wasserman, Jameson Quinn, Zac Cole, Alaa Awawda, Sabrina Irizarry, Sebastian Williams, Mark Shapiro, Al Musella, Santosh Kesari

"I’m proud to present these analyses of real-world data and clinical outcomes of CNS cancer patients from our observational registry," stated xCures’ VP of Scientific and Medical Affairs Timothy J. Stuhlmiller. "Together with leading neuro-oncologists and computational biologists, we are bringing evidence-based insights to the treatment of brain cancer patients."

The xCures platform generates Real-time, Regulatory-grade, Clinical data (RRC). It now includes data on over 1,000 brain cancer patients, permitting real-time insight into which treatments show the most promise across patient cohorts.

Emerging data on investigational and off-label interventions will be presented for patients with diffuse midline glioma (DMG), along with data from a partnership with the Institute of Systems Biology (ISB) integrating real-world clinical outcomes with a systems biology algorithm for treatment predictions to identify rational treatment options for glioblastoma patients.