On March 30, 2022 Bio-Thera Solutions, Ltd. (SH: 688177), a commercial-stage pharmaceutical company, reported that dosing has begun in Phase 1 clinical study to evaluate the pharmacokinetics, safety, and preliminary anti-tumor activity of BAT6026, a highly differentiated monoclonal antibody targeting OX40 with enhanced ADCC functions, in combination with BAT1308, a proprietary anti-PD-1 antibody currently in early-stage clinical trials (Press release, BioThera Solutions, MAR 30, 2022, View Source [SID1234611201]).

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"BAT6026 has demonstrated highly potent anti-tumor activity as a single agent and in combination with BAT1308 in in vivo pharmacology studies." said Dr. Shengfeng Li, CEO, Bio-Thera Solutions. To date, anti-OX40 antibodies as agonists have not delivered optimal clinical responses, and recent studies revealed that their activities correlate directly to antibody isotypes and Fc functions, suggesting that Treg depletion might be important in improving clinical outcomes. BAT6026 has demonstrated potent Treg depletion activity, while synergistically activating T effector cells.

This Phase 1, multicenter, open-label, dose-escalation clinical trial is designed to assess the safety and tolerability of the combination of BAT6026 and BAT1308 in advanced solid tumor patients. Key objectives in the study include determining maximum tolerated dose and recommended Phase 2 dose (RP2D), pharmacokinetics and preliminary anti-tumor activity in combination therapy. Disease-specific expansion cohorts will be enrolled at the RP2D in Australia, China and other countries to further evaluate the safety and efficacy of BAT6026 in a variety of malignancies thereafter. In addition, BAT6026 has previously entered a monotherapy clinical study in China.

Bio-Thera Solutions is developing several innovative oncology assets directed at important IO targets, including PD-1, OX40, CTLA-4, CD47, TIGIT and IO bispecifics targeting synergistic targets like PD-L1/CD47. Bio-Thera recently disclosed its next generation Antibody-Drug Conjugate (ADC) platform that has generated clinical candidate for important and validated tumor target like Folate Receptor alpha.

On March 30, 2022 BiomX Inc. (NYSE American: PHGE) ("BiomX" or the "Company"), a clinical-stage microbiome company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, reported financial results, and provided a business update for the fourth quarter and full year ended December 31, 2021 (Press release, BiomX, MAR 30, 2022, View Source [SID1234611200]).

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"BiomX is now entering the most exciting period in its history, with proof-of-concept clinical data readouts expected in the cystic fibrosis and atopic dermatitis programs within the next 12 months," said Jonathan Solomon, Chief Executive Officer of BiomX. "We are also approaching this data-rich period in good financial condition, as our existing cash runway is expected to take us until at least the end of 2023, and additional tranches that might become available to us under our venture debt facility may further extend our cash runway to the first half of 2024. We are also pleased that both the atopic dermatitis (AD) and cystic fibrosis (CF) programs have attracted equity investments in BiomX common stock from Maruho Co. Ltd. and the Cystic Fibrosis Foundation, respectively."

"Looking ahead, investors can expect our first data readout from the Phase 1b/2a cystic fibrosis program in the third quarter of 2022, which should provide valuable insights into the safety, tolerability and potential treatment effects of BX004. We also anticipate initial clinical data in the fourth quarter of this year for our Phase 1/2 atopic dermatitis product candidate, BX005. Recall that our core mission at BiomX is to develop innovative treatments with the potential to advance the current standard of care. Both our CF and AD programs reflect this potential, and we look forward to providing updates from the BX004 and BX005 programs later this year."

RECENT CORPORATE HIGHLIGHTS

In January 2022, BiomX announced that the Company received a Therapeutics Development Award of up to $5 million from the Cystic Fibrosis Foundation. The first tranche of this award closed on December 21, 2021 with the foundation investing $3 million in our shares of common stock. Upon completion of patient dosing in Part 1 of the Company’s Phase 1b/2a study of BX004, BiomX would have the right to receive the second tranche of $2 million, also as an equity investment.
In October 2021, BiomX entered into an agreement with Maruho Co. Ltd., Japan’s largest dermatology-focused pharmaceutical company, for a right of first offer to license BiomX’s atopic dermatitis product candidate, BX005, in Japan. The right of first offer will commence following the availability of results from the Phase 1/2 study of BX005. Maruho also entered into a binding agreement for an equity investment in BiomX of $3 million at a premium to the market share price, intended primarily to support the Phase 1/2 study of BX005.
Clinical Program Updates

Cystic Fibrosis ("CF") (BX004)

BX004 is being developed for the treatment of chronic respiratory infections caused by Pseudomonas aeruginosa, a main contributor to morbidity and mortality in patients with CF.
The Phase 1b/2a trial is composed of two parts and is planned to start imminently. Part 1 of the trial will evaluate the safety, pharmacokinetics and microbiologic/clinical activity of BX004 in eight CF patients in a single ascending dose and multiple dose design, with results expected in the third quarter of 2022. Part 2 of the trial will evaluate the safety and efficacy of BX004 in 24 CF patients randomized to a treatment or placebo cohort in a 2:1 ratio. Results from Part 2 are expected by the first quarter of 2023.
Atopic Dermatitis ("AD") (BX005)

BX005 is designed to shift the skin microbiome composition of AD patients to its "pre-flare" state by reducing Staphylococcus aureus burden, potentially resulting in clinical improvement.
BX005 is currently in the final stages of GMP production. The Company expects the first data readout from its Phase 1/2 proof-of-concept trial evaluating the safety and efficacy of BX005 in the fourth quarter of 2022.
Inflammatory Bowel Disease ("IBD") and Colorectal Cancer Programs

BiomX’s IBD product candidate, BX003, is planned to enter its clinical trial in 2023, and the Company’s colorectal cancer product candidate will ramp up pre-clinical efforts in 2023.
Fourth Quarter and Full Year 2021 Financial Results

Cash balance, short-term deposits and restricted cash as of December 31, 2021, were $63.1 million, compared to $57.1 million as of December 31, 2020. The increase was primarily due to net cash provided by financing activities, partially offset by net cash used in operating activities. Based upon the Company’s strategic focus on the CF and AD programs, the existing cash and cash equivalents are expected to be sufficient to fund the current operating plan through the end of 2023. Additional tranches that would become available to the Company under its venture debt facility upon satisfaction of certain specified milestones can further extend the Company’s cash runway to the first half of 2024.
Research and development ("R&D") expenses, net were $6.6 million for the three months ended December 31, 2021, compared to $6.1 million for the same period in 2020. R&D expenses, net were $22.7 million for the year ended December 31, 2021, compared to $19.4 million for the prior year. The increase was primarily due to increased expenses related to conducting pre-clinical and clinical trials of our product candidates and an increase in salaries and related expenses, mainly due to the growth in the number of employees in R&D and clinical activities, offset by a decrease resulting from receiving higher levels of grants from the Israel Innovation Authority (IIA).
General and administrative expenses were $2.8 million for the three months ended December 31, 2021, compared to $2.6 million for the same period in 2020. General and administrative expenses were $11.3 million for the year ended December 31, 2021, compared to $9.3 million for the prior year. The increase was primarily due to an increase in expenses associated with operating as a public company, such as directors’ and officers’ insurance, listing fees and investor relations activity, and also due to an increase in stock-based compensation and salaries and related expenses, mainly due to the growth in the number of employees and due to an increase in rent and related operational expenses resulting from moving into a new facility.
Net loss for the fourth quarter of 2021 was $10.5 million, compared to $9.1 million for the same period in 2020. Net loss was $36.2 million for the year ended December 31, 2021, compared to $30.1 million for the prior year.
Net cash used in operating activities for the twelve months ended December 31, 2021 was $27.6 million, compared to $24.4 million for the same period in 2020.
Conference Call and Webcast Information

BiomX management will host a conference call and webcast today at 8:00 am ET to report financial results and business updates for the fourth quarter and full year ended December 31, 2021. To participate in the conference, please dial 1-877-407-0724 (U.S.), 1-809-406-247 (Israel), or 1-201-389-0898 (International). A live and archived webcast of the call will be available on the Investors section of the Company’s website at www.biomx.com.

On March 30, 2022 Iktos, a company specialized in Artificial Intelligence (AI) for new drug design reported a collaboration agreement with Ono Pharmaceuticals Co., Ltd., a leading pharmaceutical company based in Japan with a focus on innovative medicines dedicated to the fight against disease and pain (Press release, Iktos, MAR 30, 2022, View Source [SID1234611199]).

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Under the agreement, Iktos will apply its de novo ligand and structure-based generative modelling technologies and software Makya, its AI-based retrosynthesis analysis and planning tool Spaya, and know-how complementing Ono’s drug discovery capabilities to expedite the identification of potential pre-clinical candidates and to identify additional novel chemical matter with suitable properties for undisclosed Ono’s drug discovery programmes. ONO will acquire exclusive worldwide rights to develop and commercialize small molecule compounds discovered in the collaboration. Iktos will receive research funding plus milestone payments based on achievement of certain milestones. Ono scientists will benefit from direct access to Iktos Makya and Spaya software platforms as part of the collaboration.

Iktos’s AI technology, based on deep generative models, helps to bring new insights and directions into the drug discovery process based on a comprehensive data-driven chemical structure generation technology. The technology automatically designs virtual novel molecules with all the characteristics of a successful drug molecule. This approach, validated through multiple collaborations, is a novel solution to one of the key challenges in drug design: rapid identification of molecules that simultaneously satisfy multiple parameters, such as potency, selectivity, safety, and project-specific properties. This approach uniquely enables the exploration of chemical space and produces innovative molecule designs with optimized properties. Iktos makes its AI technology available to its customers both through research collaborations and through direct access to its SaaS platforms Makya for de novo design and Spaya for synthesis planning.

"We are very pleased to collaborate with Ono, a leading pharmaceutical company based in Japan, and proud to announce our first collaboration deal with a Japanese pharma company," said Yann Gaston-Mathé, Co-founder and CEO of Iktos. "Our ultimate objective is to expedite drug discovery and achieve time and cost efficiencies for our collaborators by using Iktos’s proprietary AI platform and know-how. We are confident that together we will be able to identify promising novel chemical matter and solve complex multiparametric optimisation problems for Ono’s drug discovery programmes. We are committed to tackle challenging problems alongside our collaborators where we can demonstrate value generation for new and on-going drug discovery projects."

"Iktos has excellent artificial intelligence technology and platform in drug discovery," said Toichi Takino, Senior Executive Officer / Executive Director, Discovery & Research of Ono. "Through this drug discovery collaboration, we are excited to work with Iktos to identify and develop the next generation of innovative treatments, leading to further expansion of our development pipeline."

On March 30, 2022 Vyant Bio, Inc. ("Vyant Bio", "Company") (Nasdaq: VYNT), is an innovative biotechnology company reported that reinventing drug discovery for complex neurodevelopmental and neurodegenerative disorders (Press release, Vyant Bio, MAR 30, 2022, View Source [SID1234611198]). The Company’s central nervous system ("CNS") drug discovery platform combines human-derived organoid models of brain disease, scaled biology, and machine learning. Vyant Bio’s current programs are focused on identifying repurposed and novel small molecule clinical candidates for rare CNS genetic disorders including Rett Syndrome ("Rett"), CDKL5 Deficiency Disorders ("CDD") and familial Parkinson’s Disease ("PD"). The Company’s approach to drug discovery focuses on de-risking candidate selection, thereby improving the known effectiveness of drugs discovered earlier in the development cycle. Today, Vyant Bio will report its Fourth Quarter and Year-End 2021 highlights and business updates in a conference call and webcast scheduled for 8:30am ET.

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"Vyant Bio is committed to transforming into a pure-play drug discovery and development biotech company. We are incorporating the use of quantitative biomarkers that we believe are unique to our Rett and CDD programs that should provide meaningful human-biology-derived, preclinical signals of potential drug efficacy before the commencement of clinical trials", stated Robert T. Fremeau PhD, the Company’s Chief Scientific Officer.

"We believe our drug discovery approaches will demonstrate a capital efficient and effective way to identify novel and repurposed therapeutics to treat patients with severe neurological conditions and will thereby maximize value to our shareholders," stated Jay Roberts, Chief Executive Officer of Vyant Bio.

Vyant Bio filed its Year-End 2021 on Form 10-K today with the Securities and Exchange Commission. Please refer to Vyant Bio’s Form 10-K for more detailed information with respect to our financial results for the year ended December 31, 2021.

YEAR-END 2021 FINANCIAL RESULTS

Cash and cash equivalents totaled $20.6 million as of December 31, 2021.

During the fourth quarter of 2021, we commenced the process to sell the vivoPharm business. Therefore the vivoPharm business is classified as a held-for-sale asset and its financial information as discontinuing operations as of and for the year ended December 31, 2021. Continuing operations as of and for the year ended December 31, 2021 consists of Vyant Bio and StemoniX, Inc.

Revenue from continuing operations for 2021 was $1.1 million as compared with $867 thousand in 2020. Cost of goods sold – service aggregated $408 thousand in 2021 and $384 thousand in 2020. Cost of goods sold – product aggregated $1.4 million and $717 thousand for the year ended December 31, 2021 and 2020, respectively. Substantially all of our revenue from continuing operations was generated from our Maple Grove facility. As we move this facility to internal research and development activities in 2021, the costs for this facility will have a corresponding shift to research and development costs in 2022.

Research and development costs for 2021 increased to $4.3 million as compared with $3.2 million in 2020 which was the result of increased headcount, lab and professional service costs. Selling, general and administrative expenses increased from $2.7 million in 2020 to $8.4 million in 2021 which reflects post-merger public company costs.

Overall, the net loss of $8.7 million in 2020 increased to $40.9 million in 2021. The 2021 net loss includes $26.0 million of non-cash expenses as well as $2.3 million of merger related expenses. The net loss from continuing operations aggregated $18.6 million and included non-cash expenses of $4.8 million as well as $2.3 million in merger related costs. The net loss of $22.3 million from discontinuing operations included a $20.2 million goodwill impairment charge and other non-cash expenses aggregating approximately $1.0 million.

Vyant Bio’s Conference Call and Webcast and Information

Vyant Bio’s management will host a conference call on Wednesday, March 30, 2022 at 8:30am ET to discuss the Fourth Quarter and Year End 2021 results and provide strategic business updates as well as answer questions. Event information is below:

Event: Investor Conference Call and Webcast for the Fourth Quarter and Year-End 2021
Date: Wednesday, March 30, 2022
Time: 8:30am ET
Dial In: Toll Free: 1.877.545.0523 Conference ID: 449263
Webcast: View Source

The live event will be recorded and available for replay. The conference call and webcast details are also included inside the Investors section of the Vyant Bio corporate website at www.vyantbio.com.

On March 30, 2022 Aravive, Inc. (Nasdaq: ARAV), a late clinical-stage oncology company developing targeted therapeutics to treat metastatic disease, reported that it has entered into definitive agreements with a single healthcare-focused institutional investor and Eshelman Ventures, LLC for the issuance and sale of an aggregate of 4,850,241 shares of its common stock (or common stock equivalents in lieu thereof) and warrants to purchase up to an aggregate of 4,850,241 shares of common stock in a registered direct offering priced at-the-market under Nasdaq rules (Press release, Aravive, MAR 30, 2022, View Source [SID1234611196]). The purchase price per share and accompanying warrant is $2.005 for the institutional investor and $2.325 for Eshelman Ventures, LLC.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The warrants to be issued to the institutional investor will be immediately exercisable, will expire five years following the issuance date and will have an exercise price of $1.88 per share. The warrants to be issued to Eshelman Ventures, LLC will be exercisable upon the approval by the stockholders of the Company of previously issued securities, will expire five years following the issuance date and will have an exercise price of $2.20 per share.

The Company’s Executive Chairman, Fredric N. Eshelman, Pharm.D., is the founder of Eshelman Ventures, LLC.

The closing of the offering is expected to occur on or about March 31, 2022, subject to the satisfaction of customary closing conditions. The gross proceeds from the offering are expected to be approximately $10 million. The Company intends to use the net proceeds from the offering to continue clinical development of batiraxcept in platinum resistant ovarian cancer and clear cell renal cell carcinoma, and for general corporate purposes.

The offering of the securities described above is being made only by means of a prospectus supplement and accompanying base prospectus. The Company has filed a shelf registration on Form S-3 (File No. 333-248612) (including a base prospectus) with the U.S. Securities and Exchange Commission ("SEC"), which was declared effective on November 20, 2020. A final prospectus supplement and accompanying base prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website, located at www.sec.gov. Electronic copies of the prospectus supplement and the accompanying base prospectus for the offering may also be obtained, when available, by contacting H.C. Wainwright & Co., LLC, at 430 Park Ave., 3rd Floor, New York, New York 10022, by telephone at (212) 856-5711, or by email at [email protected].

This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in this offering, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction