On May 12, 2022 Immunome, Inc. (Nasdaq: IMNM), a biopharmaceutical company that utilizes its human memory B cell platform to discover and develop first-in-class antibody therapeutics, reported financial results for the first quarter ended March 31, 2022 and provided a corporate update (Press release, Immunome, MAY 12, 2022, View Source [SID1234614419]).

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"We received FDA clearance to proceed with our Phase 1b clinical trial for our three-antibody cocktail, IMM-BCP-01, for the treatment of COVID-19 and patient recruitment efforts are underway. Based on the preclinical data, we believe this therapy can address the ongoing need for a substantial and effective COVID-19 antibody treatment, especially in light of the continued emergence of new variants," stated Purnanand Sarma, Ph.D., President and CEO of Immunome. "Additionally, we continue to progress IMM-ONC-01, our antibody treatment targeting IL-38, an immune modulator that appears to potently suppress innate immune response, especially in the context of cancer. IL-38 is overexpressed in multiple tumor types with significant unmet need. We are targeting an IND submission in the second half of 2022 and look forward to providing updates as they arise."

First Quarter and Subsequent Highlights

FDA Lifts Clinical Hold on Immunome’s IMM-BCP-01 IND Application for the Treatment of COVID-19. In March 2022, Immunome announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on its Investigational New Drug (IND) application for its antibody cocktail (IMM-BCP-01), for the treatment of SARS-CoV-2 (COVID-19).
In Vitro Efficacy of IMM-BCP-01 Against SARS-CoV-2 Omicron Variant in Live Virus Testing. In February 2022, Immunome announced that IMM-BCP-01 demonstrated effective neutralization of the Omicron variant of COVID-19 in in vitro testing. The combination of two antibodies in Immunome’s antibody cocktail, IMM20253/IMM20184, demonstrated neutralization of the Omicron variant within 3.5-fold potency compared to a preclinical version of sotrovimab in a head-to-head test using live virus samples.
Financial Highlights

Research and development (R&D) expenses: R&D expenses for the three months ended March 31, 2022 were $8.1 million.
General and administrative (G&A) expenses: G&A expenses for the three months ended March 31, 2022 were $3.6 million.
Net loss: Net loss for the three months ended 2022 was $11.7 million.
Cash and cash equivalents: As of March 31, 2022, cash and cash equivalents totaled $42.9 million.
This investigational work was funded by the U.S. Department of Defense’s (DOD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) in collaboration with the Defense Health Agency (DHA) (Contract number: W911QY-20-9-0019).

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On May 12, 2022 Xilio Therapeutics, Inc. (Nasdaq: XLO), a biotechnology company developing tumor-selective immuno-oncology therapies for people living with cancer, reported pipeline and business highlights and reported financial results for the first quarter ended March 31, 2022 (Press release, Xilio Therapeutics, MAY 12, 2022, View Source [SID1234614482]).

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"Leveraging our geographically precise solutions (GPS) platform, we are developing a pipeline of tumor-selective immunotherapies that have the potential to achieve meaningful anti-tumor activity while minimizing serious, systemic effects," said René Russo, Pharm.D., president and chief executive officer of Xilio. "We continue to progress enrollment in our Phase 1 clinical programs, XTX101 and XTX202, with planned preliminary data readouts later this year, and we remain on track with our plans to submit an IND application for XTX301 in the second half of 2022. With our strong financial position and an outstanding team in place, we believe we are well-positioned to advance our pipeline of tumor-selective immuno-oncology programs with the goal of transforming the lives of people living with cancer."

Pipeline and Business Progress

Cytokine Programs

Enrollment is ongoing in the Phase 1 clinical trial evaluating XTX202 for the treatment of patients with solid tumors, with preliminary data anticipated to be reported in the second half of 2022. XTX202 is a tumor-selective interleukin-2 (IL-2) designed to localize activity in the tumor microenvironment, with the goal of overcoming the known tolerability challenges of existing IL-2 therapies while achieving enhanced anti-tumor activity as monotherapy and in combination with standard of care agents.
Preclinical data from the XTX301 program was presented at the New York Academy of Sciences Frontiers in Cancer Immunotherapy 2022 conference on May 10, 2022. XTX301 demonstrated tumor-selective activation in patient-derived tumor explants, and a murine surrogate of XTX301 (mXTX301) induced significant tumor growth inhibition in a mouse model and improved tolerability compared to a non-tumor-selective version of mXTX301. View the poster online here.
Xilio continues to anticipate submitting an investigational new drug application (IND) for XTX301, a tumor-selective interleukin-12 (IL-12), in the second half of 2022 for evaluation in patients with solid tumors.

Upcoming Presentations

A trials-in-progress poster outlining details of the ongoing Phase 1/2 clinical trial for XTX202 will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2022 Annual Meeting:

Presentation title: A first-in-human, multicenter, phase 1/2, open-label study of XTX202, a masked and tumor-selective recombinant human interleukin-2 (IL-2) protein, in patients with advanced solid tumors
Session date and time: Sunday, June 5, 2022, 8:00-11:00 AM CDT
Abstract number: TPS2697
Checkpoint Inhibitor Program

Enrollment is ongoing in the Phase 1 clinical trial evaluating XTX101, a tumor-selective anti-CTLA-4 monoclonal antibody, as a monotherapy and in combination with pembrolizumab, an anti-PD-1, for the treatment of patients with advanced solid tumors.
Preliminary data for the Phase 1 clinical trial for XTX101 is anticipated to be reported from the monotherapy cohort in the middle of 2022 and from the combination cohort in the second half of 2022.
First Quarter 2022 Financial Results

Cash Position: Cash and cash equivalents were $177.0 million as of March 31, 2022, as compared to $198.1 million as of December 31, 2021. The decrease was primarily driven by cash used in operations for the three months ended March 31, 2022.
Research & Development (R&D) Expenses: R&D expenses were $14.9 million for the first quarter of 2022, compared to $11.6 million for the first quarter of 2021. The increase was primarily driven by increased costs associated with XTX301 and other preclinical programs, as well as higher personnel-related costs due to increased headcount.
General & Administrative (G&A) Expenses: G&A expenses were $6.3 million for the first quarter of 2022, compared to $4.9 million for the first quarter of 2021. The increase was primarily driven by higher personnel-related costs due to increased headcount and other costs related to operating as a publicly traded company.
Net Loss: Net loss was $21.4 million for the first quarter of 2022, compared to $16.7 million for the first quarter of 2021.
Financial Guidance

As a result of prioritization within the company’s preclinical portfolio, Xilio now anticipates that its existing cash and cash equivalents will be sufficient to fund its operating expenses and capital expenditure requirements into the first half of 2024.

On May 12, 2022 Diffusion Pharmaceuticals Inc. (NASDAQ: DFFN) ("Diffusion" or the "Company"), a biopharmaceutical company developing novel therapies that enhance the body’s ability to deliver oxygen to areas where it is needed most, reported financial results for the quarter ended March 31, 2022, and provided a business update (Press release, Diffusion Pharmaceuticals, MAY 12, 2022, View Source [SID1234615255]).

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Business Updates

Completed Dosing in Altitude Trial: The Company announced the last participant in this study of its lead product candidate, trans sodium crocetinate ("TSC"), completed dosing in April 2022 and topline data are expected in June 2022. Two abstracts, based on blinded, aggregated (placebo and treatment), interim physiological data from a subset of study participants, will be presented by the clinical investigators at the Undersea and Hyperbaric Medical Society’s Annual Scientific Meeting in Reno, Nevada being held from May 22-26, 2022.
Continued Enrollment in TSC ILD-DLCO Trial: Diffusion announced dosing of the first patients in December 2021 and enrollment continued during the first quarter of 2022. The Company currently anticipates completing dosing in the second half of 2022 and reporting topline results within two months of study completion.
Expanded Scientific Advisory Board: In February 2022, the Company announced the addition of five prominent radiation and medical oncologists to its Scientific Advisory Board ("SAB") to further support development of TSC, as an adjunctive treatment for hypoxic solid tumors.
Maintained Solid Cash Position: As of March 31, 2022, Diffusion reported $32.6 million in cash, cash equivalents, and marketable securities, which is expected to fund the Company’s operating expenses and capital expenditure requirements through 2023.
Regained Nasdaq Compliance: In May 2022, the Company announced that it had regained compliance with the Nasdaq Capital Market’s continued listing requirements, following the bid price of the Company’s common stock closing above $1.00 for 10 consecutive trading days.
"We believe 2022 has the potential to be a transformational year, as we anticipate the topline data readout from the Altitude Trial in June and the completion of patient dosing in our ILD-DLCO trial later this year," commented Robert Cobuzzi, Jr., Ph.D., President and Chief Executive Officer of Diffusion. "With our strong cash position, experienced development team, and the appointment of our new and distinguished SAB members, we believe Diffusion is now effectively positioned to launch our Hypoxic Solid Tumor Program aimed at evaluating TSC as an adjunctive treatment for hypoxic solid tumors. Our team worked hard during the first quarter, evaluating various options in designing an appropriate clinical study protocol and amending our oncology investigational new drug application for TSC to support a start date for the first trial in the program in the second half of 2022. We look forward to providing updates on these development activities that we hope will drive both patient and shareholder value."

Financial Results

Research and development expenses in the first quarter of 2022 were $2.4 million, compared to $2.9 million in the prior year period. A significant portion of this decrease was attributable to the timing of clinical trials and drug manufacturing, offset by an increase in salaries, wages and stock-based compensation related to increased headcount.
General and administrative expenses were $2.1 million during the first quarter of 2022 versus $1.7 million in the comparable quarter last year. The increase compared to the prior year period was mainly due to an increase in salaries, wages, and stock-based compensation related to increased headcount, as well as an increase in outside professional fees to support business activities during the quarter.
As of March 31, 2022, Diffusion had cash, cash equivalents, and marketable securities of $32.6 million, compared to $46.6 million as of March 31, 2021.

On May 12, 2022 Kuraray Co., Ltd. reported (Press release, Kuraray, MAY 12, 2022, https://pdf.irpocket.com/C3405/wigp/TW1Q/plJB.pdf [SID1234614264])

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1. Consolidated Financial Results for the First Quarter of the Fiscal Year Ending December 31, 2022 (January 1, 2022 to March 31, 2022)
(1) Consolidated Operating Results (Percentage changes displayed for net sales, operating income, ordinary income and net income attributable to owners of the parent are comparisons with the corresponding period of the previous fiscal year.)
(2) Consolidated Financial Position

2. Dividends
3. Forecasts of Consolidated Financial Results for the Fiscal Year Ending December 31, 2022 (January 1, 2022 to December 31, 2022) (Percentage changes displayed for net sales, operating income, ordinary income and net income attributable to owners of the parent are comparisons with the corresponding period of the previous fiscal year.)