On August 15, 2024 Aarvik Therapeutics, a biotechnology company dedicated to engineering precision medicines for cancer therapy, reported that its collaboration partner ArriVent BioPharma, Inc. has exercised the option to exclusively license the collaboration program (Press release, Aarvik Therapeutics, AUG 15, 2024, View Source [SID1234645954]).

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As part of the research collaboration agreement entered into between Aarvik and ArriVent on December 21, 2021, Aarvik has been responsible for discovery and preclinical development of a novel ADC molecule that relies on the unique modular platform developed by Aarvik. ArriVent will be responsible for clinical development and commercialization. Aarvik has received an upfront payment, research funding and an opt-in payment, and is eligible to receive contingent development and commercial milestones, plus royalties.

"Aarvik has shown that it can combine the most advanced protein engineering technologies with deep ADC drug development expertise to enable next-generation, best-in-class oncology therapies," said Jagath Reddy Junutula, PhD, Co-founder, President and CEO of Aarvik Therapeutics. "Aarvik will continue to pursue previously hard-to-treat indications through the power of its novel multi-targeting platforms."

"We are delighted to see Aarvik reach this significant milestone," said Sachdev Sidhu, PhD, Co-founder and Board member of Aarvik Therapeutics. "This provides further validation and underscores the power and potential of Aarvik antibody platforms and deep protein engineering capabilities."

On August 15, 2024 EnPlusOne Biosciences, Inc., a biotechnology company harnessing the power of enzymes to deliver better RNA at scale, reported that it is part of a collaboration led by the Wyss Institute for Biologically Inspired Engineering at Harvard University that has been awarded an agreement for up to $27 million by the Advanced Research Projects Agency for Health (ARPA-H) (Press release, EnPlusOne Biosciences, AUG 15, 2024, View Source [SID1234645955]). The agreement covers multi-disciplinary efforts to develop a disease-agnostic novel RNA therapeutic with the potential to treat diverse diseases, including types of cancer and infectious diseases, and to be effectively and rapidly deployable. Initially, up to $3.5 million of the agreement is focused on the EnPlusOne enzymatic platform.

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ARPA-H is a federal funding agency which funds transformative biomedical and health research breakthroughs, translating prioritized research from the lab to applications in the marketplace. The ARPA-H award will allow the Wyss Institute team to significantly accelerate and expand efforts to advance the therapy towards an Investigational New Drug (IND) submission to the Federal Food and Drug Administration (FDA).

The team is initially focusing on cancer and will explore the platform’s potential for difficult-to-treat infectious diseases. The ARPA-H project will build on a newly developed Duplex RNA technology and leverage the powerful RNA delivery capabilities developed by groups at the Wyss Institute, along with the groundbreaking enzymatic RNA synthesis capabilities of EnPlusOne to optimize the RNA’s design and scalability.

Dan Ahlstedt, co-founder and Chief Operating Officer said, "We come full circle rejoining our Wyss colleagues for this exciting collaboration. This comprehensive program will give us the opportunity to demonstrate how enabling modifications and limitless scale can be unlocked by our ezRNA platform. We are grateful to the Wyss Institute and ARPA-H for recognizing the current problems facing RNA manufacturing and sharing our vision that an enzymatic approach is the future. We look forward to progressing our platform alongside this team as we collectively work to address critical human health challenges."

Wyss Institute Core Faculty member Natalie Artzi, Ph.D. is the lead-investigator on the project with co-principal investigator and Wyss Institute Founding Director Don Ingber, M.D., Ph.D. Artzi also is Associate Professor of Medicine at Harvard Medical School (HMS) and Brigham and Women’s Hospital and a Principal Research Scientist at MIT. Additional key investigators include Wyss Institute Director of Translational R&D Kenneth Carlson, Ph.D., a drug discovery and development specialist with extensive industry experience, and Wyss Institute Core Faculty member William Shih, Ph.D., who developed a DNA origami platform that allows the precise and highly effective presentation of RNA drugs, cancer and pathogen-derived antigens, and immune activating adjuvants to the immune system. Shih’s team will provide their DNA nanotechnology approach as an additional drug delivery option.

The collaboration is another validation of the potential for enzymatic synthesis to address the needs of a rapidly expanding RNA therapeutic market as the industry faces demand for RNA production that cannot be met by chemical synthesis alone. It builds upon recent important progress shared by EnPlusOne, including the breakthrough synthesis of the antisense strand of the commercially approved siRNA drug, Leqvio (inclisiran), a treatment for hypercholesteremia (high cholesterol) licensed from Alnylam Pharmaceuticals, Inc. by Novartis, that currently addresses a multi-million patient population.

EnPlusOne was launched by the Wyss Institute in 2022 to commercialize its enzymatic RNA oligonucleotide synthesis technology developed in the laboratory of co-founder George Church, PhD. Seed financing was led by Northpond Ventures, with participation from Breakout Ventures, Coatue, and individual investors.

On August 15, 2024 Aligos Therapeutics, Inc. (Nasdaq: ALGS, "Aligos", "Company"), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver and viral diseases, reported that it will effect a 1-for-25 reverse stock split of its shares of common stock (Press release, Aligos Therapeutics, AUG 15, 2024, View Source [SID1234645940]). The reverse stock split will become effective at 12:01 am ET on Monday, August 19, 2024. The Company’s common stock is expected begin trading on the Nasdaq Capital Market under the same symbol (ALGS) on a split-adjusted basis at the market open on August 19, 2024 with the new CUSIP number 01626L 204.

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At the effective time, all outstanding stock options, warrants, and equity incentive plans will be proportionally affected. Every 25 shares of issued and outstanding shares of the company’s common stock will automatically be reclassified into one issued and outstanding share of common stock without any change in the par value of $0.0001 per share. No fractional shares will be issued in connection the reverse stock split and stockholders will be entitled to a cash payment in lieu of fractional shares. The reverse stock split will affect all stockholders uniformly and will not affect any stockholder’s ownership percentage of Aligos’s shares, except for those stockholders receiving a cash payment in lieu of fractional shares.

The Company is primarily implementing the reverse stock split to enable it to regain compliance with the Nasdaq $1.00 minimum bid price requirement. The reverse stock split was approved by the Company’s stockholders at the Annual Meeting of Stockholders on June 27, 2024. Subsequently, the Board of Directors approved the reverse stock split at a ratio of 1-for-25.

Continental Stock Transfer & Trust Company is acting as the exchange and transfer agent for the reverse stock split. Continental will provide instructions to stockholders with registered shares and those receiving a cash payment for fractional shares, if any. Those stockholders with shares in "street name" will have their positions automatically adjusted, subject to each broker’s processes. If any action is required, each stockholder will receive instructions directly from their broker.

Additional information about the reverse stock split can be found in the definitive proxy statement filed with the Securities and Exchange Commission (SEC) on April 29, 2024, which is available on the SEC’s website, www.sec.gov, and the company’s website at www.aligos.com.

On August 15, 2024 Nuntius Therapeutics ("Nuntius"), a biotech company developing transformative mRNA therapies through their advanced delivery technology, reported that they have entered into a collaboration agreement with Taiho Pharmaceutical Co., Ltd. ("Taiho"), a leading company in Japan for developing innovative medicines for the treatment of cancer (Press release, Nuntius Therapeutics, AUG 15, 2024, View Source [SID1234645957]). Taiho will use Nuntius’ cell-specific peptide dendrimer- and lipid-based nanocarriers to develop novel mRNA cancer immunotherapies.

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The collaboration agreement follows a successful feasibility study which evaluated Nuntius’ delivery capabilities.

"We are thrilled to embark on this collaboration with Taiho to improve treatments for cancer patients. Taiho is an excellent partner for us given their strong oncology focused research and commercial capabilities," said Benita Nagel, CEO & Co-Founder of Nuntius.

"Delivery remains a major challenge for mRNA therapies. This agreement validates our nanocarriers as an exceptionally effective cell-specific delivery technology for genetic medicines," added Albert Kwok, PhD, CSO & Co-Founder of Nuntius.

The financial terms of the collaboration agreement were not disclosed.

Nuntius’ programmable and scalable nanocarriers can effectively and safely target cell types beyond the liver and outperform leading delivery technologies. The company recently published its machine learning approach to discovering high-performing mRNA nanocarriers in the journal Advanced Science. Nuntius’ high-throughput, in silico screening of delivery vehicle candidates significantly reduces the time and cost required to bring mRNA therapies to the clinic.

On August 15, 2024 Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, reported its financial results for the second quarter ended June 30, 2024 and provided an update on recent corporate developments (Press release, Bio-Path Holdings, AUG 15, 2024, View Source [SID1234645941]).

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"The first half of 2024 was marked by considerable corporate and clinical progress across the organization. We were encouraged by the bolus of data we presented at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) as they underscore the potential of a prexigebersen combination regimen as a safe and effective treatment for some of the most vulnerable cancer patients," said Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings. "Moving forward, we are excited to advance these important programs in support of our mission to deliver effective therapies without harsh side effects so that even the most fragile patients can have tolerable treatment options."

Recent Corporate Highlights

● Presented Data at American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. In June, Bio-Path presented interim results from the Company’s Phase 2 study of prexigebersen (BP1001) in combination with decitabine and venetoclax for the treatment of acute myeloid leukemia (AML) in an oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, IL.

● Showcased Data at European Hematology Association (EHA) (Free EHA Whitepaper) Congress. In June, the Company presented interim results from the Company’s Phase 2 study of prexigebersen (BP1001) in combination with decitabine and venetoclax for the treatment of AML in a poster presentation at 2024 European Hematology Association (EHA) (Free EHA Whitepaper) Congress in Madrid, Spain.

● Closed $4.0 Million Private Placement. In June, Bio-Path closed a private placement for the issuance and sale of an aggregate of 1,809,955 shares of its common stock (or common stock equivalents in lieu thereof), series A warrants to purchase up to 1,809,955 shares of common stock and short-term series B warrants to purchase up to 1,809,955 shares of common stock at a purchase price of $2.21 per share of common stock (or per common stock equivalent in lieu thereof) and accompanying warrants priced at-the-market under Nasdaq rules.

Financial Results for the Second Quarter Ended June 30, 2024

● The Company reported a net loss of $1.9 million, or $1.16 per share, for the three months ended June 30, 2024, compared to a net loss of $4.2 million, or $10.64 per share, for the three months ended June 30, 2023.

● Research and development expense for the three months ended June 30, 2024 decreased to $1.9 million, compared to $3.1 million for the three months ended June 30, 2023 primarily due to decreased manufacturing expenses related to drug product releases partially offset by an increase in expense related to our clinical trial for BP1002 in lymphoma due to increased patient enrollment in 2024.

● General and administrative expense for each of the three months ended June 30, 2024 and June 30, 2023 was $1.2 million.

● As of June 30, 2024, the Company had cash of $4.0 million, compared to $1.1 million as of December 31, 2023. Net cash used in operating activities for the six months ended June 30, 2024 was $4.3 million compared to $6.9 million for the comparable period in 2023. Net cash provided by financing activities for the six months ended June 30, 2024 was $7.2 million.

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 second quarter 2024 financial results and to provide a general update on the Company. To access the conference call please dial (844) 481-3014 (domestic) or (412) 317-1879 (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.