On February 10, 2023 Nona Biosciences, a wholly-owned subsidiary of HBM Holdings Limited committed to cutting edge technology innovations, and providing a total solution from "Idea to IND" ("I to ITM"), reported that it has entered into a collaboration agreement with Mythic Therapeutics, a biotechnology company focused on the development of antibody-drug conjugate-based (ADC) therapies for the treatment of a wide range of cancers (Press release, Nona Biosciences, FEB 10, 2023, View Source [SID1234627078]).

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Through the collaboration, Nona Biosciences will provide Mythic Therapeutics with access to its proprietary fully human heavy chain only antibody (HCAb) transgenic mice platform and antibody generation services to serve as input for Mythic Therapeutics’ proprietary FateControl antibody engineering approach to generate next-generation ADCs for a wide range of cancers.

"We are delighted to reach the agreement with Mythic Therapeutics to advance next-gen biotherapeutics innovation. We’ve accumulated deep knowledge of ADC drug discovery, along with our advanced therapeutic antibody platforms which have been validated by many partners worldwide. Mythic Therapeutics is a strong innovator in the research and development of ADCs in oncology with a strong foundation and a world-class team. Our cooperation is expected to further enhance the ability of target discovery, translating to advanced outcomes for unmet medical needs." said Jingsong Wang, MD, PhD, Chairman of Nona Biosciences.

About HCAb

HCAb’s patented technology generates novel "heavy chain only" antibodies, which are about half the size of a typical IgG. These antibodies carry IgG-like PK properties and Fc-domain functions without the need for additional engineering or humanization. Lack of light chain also minimizes the issue of light chain mispairing and heterodimerization. These characteristics enable the development of products with attributes not achievable by conventional antibody platforms. In addition, HCAb-derived multiple novel therapeutic antibody modalities, including single-domain antibodies, bi-, and multi-specifics, antibody-drug conjugates, CAR-Ts, or VH domain-derived diagnostic or therapeutic products, are also achievable using this platform.

On February 10, 2023 Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products reported business and financial results for the fiscal first quarter ended December 31, 2022 (Press release, Citius Pharmaceuticals, FEB 10, 2023, View Source [SID1234627077]).

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Fiscal Q1 2023 Business Highlights and Subsequent Developments

I/ONTAK (E7777) biologics license application (BLA) under review by the U.S. Food and Drug Administration (FDA) with Prescription Drug User Fee Act (PDUFA) target decision date of July 28, 2023;
Mino-Lok Phase 3 trial progressing with additional enrollment and events in the U.S. and India;
Phase 2b trial of Halo-Lido for the treatment of hemorrhoids on track with healthy momentum in patient recruitment; and,
On February 7, 2023, Dennis M. McGrath was elected to the Citius Board of Directors at the Annual Meeting of Stockholders, replacing Director Dr. William Kane.
Financial Highlights

Cash and cash equivalents of $36.9 million as of December 31, 2022;
R&D expenses were $3.4 million for the first quarter ended December 31, 2022, compared to $5.5 million for the first quarter ended December 31, 2021;
G&A expenses were $2.6 million for the first quarter ended December 31, 2022, compared to $2.9 million for the first quarter ended December 31, 2021;
Stock-based compensation expense was $1.2 million for the first quarter ended December 31, 2022, compared to $0.9 million for the first quarter ended December 31, 2021; and,
Net loss was $3.6 million, or ($0.02) per share for the first quarter ended December 31, 2022, compared to a net loss of $9.2 million, or ($0.06) per share for the first quarter ended December 31, 2021.
"As we entered 2023, Citius continued to build momentum across the pipeline. Our Mino-Lok Phase 3 trial is actively enrolling patients in the U.S. and India. We believe the recent uptick in recruitment at clinical sites will aid in completing the trial this year. Regarding our I/ONTAK (E7777) BLA, we anticipate the FDA’s decision in late July. Accordingly, we remain focused on ensuring that our regulatory, commercial and manufacturing activities are positioned to support a successful launch, if approved. Moreover, our team has worked diligently to align resources to support the Phase 2b Halo-Lido trial as it nears completion," stated Leonard Mazur, Chairman and CEO of Citius.

"In addition to the progress we are making on the clinical front, we continue to strengthen our corporate infrastructure. On February 7, 2023, shareholders approved the nomination of Dennis McGrath to our Board of Directors. We are very fortunate to have a seasoned leader of Dennis’s caliber join our Board. His deep public company, financial and strategic expertise will help guide our path forward. Dennis assumes the Board position formerly held by Dr. William Kane. Since March 2014, Dr. Kane has shared his expertise and insights as a valued member of our Board. We are grateful for his contributions and support through the years. With multiple value-creating catalysts anticipated this year, I look forward to updating shareholders as we work to achieve these milestones," concluded Mazur.

FIRST QUARTER 2023 FINANCIAL RESULTS:

Liquidity

As of December 31, 2022, the Company had $36.9 million in cash and cash equivalents.

As of December 31, 2022, the Company had 146,211,130 common shares outstanding.

The Company estimates that its available cash resources will be sufficient to fund its operations through February 2024.

Research and Development (R&D) Expenses

R&D expenses were $3.4 million for the first quarter ended December 31, 2022, compared to $5.5 million for the first quarter ended December 31, 2021. The decrease primarily reflects the completion of the I/ONTAK (E7777) Phase 3 trial and lower Halo-Lido Phase 2b study costs, offset by incremental Mino-Lok Phase 3 trial costs related to the expansion of the trial to include clinical sites outside the U.S.

We expect that research and development expenses will stabilize in fiscal 2023 as we focus on the commercialization of I/ONTAK and complete our Phase 3 trial for Mino-Lok and our Phase 2b trial for Halo-Lido.

General and Administrative (G&A) Expenses

G&A expenses were $2.6 million for the first quarter ended December 31, 2022, compared to $2.9 million for the first quarter ended December 31, 2021. The decrease was primarily due to reduced costs for performance bonuses and investor relations expenses. General and administrative expenses consist primarily of compensation costs, professional fees for legal, regulatory, accounting, and corporate development services, and investor relations expenses.

Stock-based Compensation Expense

For the first quarter ended December 31, 2022, stock-based compensation expense was $1.2 million as compared to $0.9 million for the prior year. The increase reflects expenses related to new grants made under the Citius and NoveCite equity incentive plans and new grants made to employees (including new hires), directors and consultants.

Net loss

Net loss was $3.6 million, or ($0.02) per share for the year ended December 31, 2022, compared to a net loss of $9.2 million, or ($0.06) per share for the year ended December 31, 2021. The $5.6 million decrease in the net loss was primarily due to an increase in other income and a decrease in research and development expenses.

On February 10, 2023 Kineta, Inc. (the "Company") entered into an Open Market Sale AgreementSM (the "Agreement") with Jefferies LLC, as sales agent ("Jefferies"), pursuant to which the Company may offer and sell (the "Offering"), from time to time at its sole discretion through Jefferies, shares of the Company’s common stock, par value $0.001 per share (the "Shares"), having an aggregate offering price of up to $17,500,000, subject to the offering limits in General Instruction I.B.6 to Form S-3 (Filing, 8-K, Yumanity Therapeutics, FEB 10, 2023, View Source [SID1234627076]).

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Subject to the terms and conditions of the Agreement, Jefferies has agreed to use its commercially reasonable efforts, consistent with its normal trading and sales practices, to sell from time to time the Shares so designated by the Company as sales agent in accordance with the Company’s instructions (including any price, time or size limits or other customary parameters or conditions the Company may impose). The Company cannot provide any assurances that it will issue any Shares pursuant to the Agreement. The sales, if any, of the Shares under the Agreement may be made by any method permitted that is deemed an "at the market offering" as defined in Rule 415(a)(4) under the Securities Act of 1933, as amended (the "Securities Act"), or in privately negotiated transactions or block transactions. The Agreement provides that the commission payable to Jefferies for sales of the Shares with respect to which Jefferies acts as sales agent shall be 3.0% of the gross proceeds from the sale of such Shares sold pursuant to the Agreement. The Agreement contains customary representations and warranties of the parties and indemnification and contribution provisions under which the Company has agreed to indemnify Jefferies against certain liabilities, including liabilities under the Securities Act and the Securities Exchange Act of 1934, as amended. The Company will also reimburse Jefferies for certain expenses incurred in connection with the Agreement. The Offering will terminate upon the earliest of (a) the sale of the maximum number or amount of the Shares permitted to be sold under the Agreement and (b) the termination of the Agreement by the parties thereto.

The Company currently intends to use any net proceeds from the Offering as described in the Prospectus Supplement (as defined below).

The foregoing description of the Agreement is not complete and is qualified in its entirety by reference to the full text of the Agreement, a copy of which is filed as Exhibit 1.1 to this Current Report on Form 8-K and is incorporated herein by reference.

Offers and sales of the Shares by the Company under the Agreement, if any, will be made pursuant to a shelf registration statement on Form S-3 (File No. 333-269340) that was declared effective by the U.S. Securities and Exchange Commission (the "SEC") on January 30, 2023 and a related prospectus, dated January 30, 2023, and prospectus supplement, dated February 10, 2023 (the "Prospectus Supplement"), in each case, filed with the SEC. As further described in the Prospectus Supplement, as of February 7, 2023, due to the limitations set forth in General Instruction I.B.6 to Form S-3, the Company may offer and sell Shares having an aggregate offering price of up to $17,500,000 from time to time through Jefferies pursuant to the Agreement. If the Company’s public float increases such that it may sell additional Shares under the Agreement, the Company will file a new prospectus supplement with the SEC prior to making such additional sales.

The legal opinion of Orrick, Herrington & Sutcliffe LLP relating to the legality of the Shares and related consent are attached as Exhibits 5.1 and 23.1, respectively, to this Current Report on Form 8-K.

This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy the securities discussed herein, nor shall there be any offer, solicitation, or sale of the securities in any state or country in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or country.

Item 1.02. Termination of Material Definitive Agreement.

On February 10, 2023, the Company terminated the Open Market Sale AgreementSM, dated as of December 3, 2021 (the "Prior Sale Agreement"), by and between the Company and Jefferies.

The termination of the Prior Sale Agreement was effective on February 10, 2023. As previously reported, pursuant to the terms of the Prior Sale Agreement and the related prospectus filed with the SEC on December 3, 2021, the Company could offer and sell shares of its common stock having an aggregate offering price of up to $60 million from time to time through Jefferies. The Company is not subject to any termination penalties related to the termination of the Prior Sale Agreement. The Company sold 35,291 shares of its common stock for gross proceeds of approximately $0.5 million pursuant to the Prior Sale Agreement through the termination date of such agreement. The Company will not make any further sales of shares of its common stock under the Prior Sale Agreement and the related prospectus supplement.

On February 10, 2023 Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a clinical stage biotechnology company whose proprietary INTASYL RNAi platform technology is designed to make immune cells more effective in killing tumor cells, reported that an independent Data Monitoring Committee (DMC) completed its prespecified review of interim safety data in the Company’s Phase 1b clinical trial of PH-762 for the treatment of advanced melanoma (Press release, Phio Pharmaceuticals, FEB 10, 2023, View Source [SID1234627075]). The trial is ongoing at the Gustave Roussy Institute (Villejuif, France), one of the largest cancer centers in Europe. PH-762 is an INTASYL compound that reduces the expression of cell death Protein 1 (PD-1), a protein that inhibits T cells’ ability to kill cancer cells. Decreasing the expression of PD-1 increases the capacity of T cells to kill cancer cells.

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Following completion of the treatment period through excision of the tumor, safety data from the initial cohort of three subjects in the Phase 1 trial was evaluated by the DMC. The safety data review disclosed no dose-limiting toxicity, and no drug-related severe adverse events or serious adverse events, and the DMC recommended proceeding to the enrollment of the subsequent dose cohort, as intended per the study protocol.

"We are pleased with the recommendation of the DMC as a reflection of the favorable safety and tolerability profile of PH-762 to date, and will continue to obtain additional safety data as well as evidence of pharmacologic effect as we develop PH-762 for advanced cutaneous tumors," said Robert Bitterman, Phio’s Principal Executive Officer and Executive Chairman.

In addition to the Phase 1b study in France, Phio expects to commence a US Phase 1b clinical trial focusing on the treatment of cutaneous squamous cell carcinoma (cSCC) and other selected cutaneous malignancies, early in the 2nd half of 2023.

About the Phase 1b Trial in Advanced Melanoma

The Phase 1b trial is an open-label, dose escalation trial that is expected to enroll up to 21 patients with advanced melanoma. PH-762 will be administered as a neoadjuvant monotherapy intratumorally once a week, for a total of four injections, across five dose levels which are normalized to tumor volume. Dosing will be followed by tumoral excision after an additional two weeks. The primary study objectives are: to evaluate the safety and tolerability, and pharmacokinetics of PH-762; to determine the potential immunologic and pathologic tumor responses; and to determine the recommended dose for later clinical studies. Tumor changes will be evaluated per RECIST criteria, adapted for use with intratumoral therapy, and by pathological response.

About INTASYL

INTASYL compounds are chemically modified siRNAs that provide efficient, spontaneous cellular uptake and potent, long lasting intracellular activity, targeting a broad range of cell types and tissues. INTASYL drugs precisely target specific proteins that reduce the body’s ability to fight cancer, without the need for specialized formulations or drug delivery systems. INTASYL has demonstrated preclinical efficacy in both Direct-to-Tumor and Adoptive Cell Therapy (ACT) applications.

In comparison to biologics and cell and gene therapies, INTASYL has a favorable pre-clinical toxicity and safety profile, and a streamlined chemical synthesis that reduces costs and offers substantial dosing convenience to the prescriber and patient. INTASYL is the only self-delivering RNA interference (RNAi) technology focused on immuno-oncology therapeutics.

On February 10, 2023 LIXTE Biotechnology Holdings, Inc. ("LIXTE" or the "Company") (Nasdaq: LIXT) noted that a team of scientists headed by Professor Rene Bernards at the Netherlands Cancer Institute, Amsterdam and member of the Board of Directors of LIXTE reported that in three difficult to treat cancer types, LIXTE’s lead clinical compound, LB-100, combined with an inhibitor of the WEE1 kinase, causes unexpectedly effective cancer cell killing. Most surprisingly, when cancer cells acquire resistance to this combination therapy, they have highly reduced cancer-causing capacity in animal models (Press release, Lixte Biotechnology, FEB 10, 2023, View Source [SID1234627074]). This observation indicates that this LB-100 combination therapy can force cells to give up their cancer-causing properties to acquire drug resistance.

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John S. Kovach, M.D., CEO and Founder of LIXTE, and a co-author of the report in BioRxiv (View Source) entitled "Paradoxical activation of oncogenic signaling as a cancer treatment strategy" commented, "Over the past 20 years, efforts to develop better cancer therapies have focused on inhibiting the stimulatory effects of the oncogenes, but such therapies often deliver only modest benefit to patients with advanced cancer due to development of resistance. Dr. Matheus Henrique Dias, working in the laboratory of Professor Rene Bernards at the Netherlands Cancer Institute, Amsterdam, and an international team of collaborators, have now shown that treatment of cancer cells with Lixte’s unique lead clinical compound, LB-100, rather than inhibiting, further stimulates the signals that drive cancer cell proliferation, but paradoxically, impeding cell proliferation."

Dr. Kovach continued, "The authors also show that combination of LB-100 with an inhibitor of WEE1, a regulator of stress responses in the cell, leads to highly efficient cancer cell death in three hard-to-treat cancer models: colorectal, pancreatic, and bile duct carcinomas. The Bernards’ group contends that this paradoxical result stems from the fact that the survival of cancer cells depends on a balance between activated oncogenic pathways driving tumorigenesis and engagement of stress-response programs that counteract the inherent toxicity of such aberrant signaling. Normal cells, which are not in proliferation overdrive in the first place, apparently can tolerate transient overstimulating signaling much better than cancer cells. The combination of LB-100 and WEE1 inhibition suppressed the growth of patient-derived tumors refractory to conventional therapies and was associated with only modest toxicity in animal models."

Dr. Kovach concluded, "Intriguingly, the authors present evidence to indicate that cancer cells that become resistant to this LB-100 combination therapy do so by losing some important cancer cell characteristics and are less cancerous in animal models. This "tumor suppressive drug resistance" still needs to be demonstrated in patients. However, given the safety profile in animal models of LB-100 in combination with WEE1 inhibition, this hypothesis should be readily testable in the clinic."