On May 9, 2023 XOMA Corporation (NASDAQ: XOMA), the biotech royalty aggregator, reported its first quarter 2023 financial results and highlighted recent operational achievements as the Company accelerates XOMA’s differentiated biotech royalty and milestone acquisition strategy (Press release, Xoma, MAY 9, 2023, View Source [SID1234631303]).

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"We are increasing our efforts to be a provider of capital to emerging biotech companies, often enabling these companies to unlock value in the face of a challenging market backdrop for innovative, early stage companies," stated Owen Hughes, Executive Chairman of XOMA. "In the first quarter, the team acted rapidly and decisively to add a second cashflow-generating, long-duration asset to XOMA’s milestone and royalty portfolio. We will continue to reinvest our incoming cashflows and milestone payments to accelerate our royalty monetization strategy."

"The first five months of 2023 have demonstrated both the royalty potential within and the opportunities to grow our royalty and milestone aggregator business model. In February, we received a payment related to the commercial sales of Vabysmo (faricimab) during the second half of 2022. In March, we acquired the IXINITY [coagulation factor IX (recombinant)] commercial payment stream held by Aptevo and will begin recording those commercial payments in the second quarter of 2023," said Brad Sitko, Chief Investment Officer of XOMA. "The team and I are actively identifying additional royalty and milestone acquisition agreements that can deliver significant value to XOMA and our shareholders."

First Quarter 2023 Financial Results

XOMA recorded total revenues of $0.4 million for the first quarter of 2023, compared with $3.1 million in the first quarter of 2022. In the first quarter of 2022, XOMA recognized $2.0 million in revenue related to a milestone event under the Company’s license agreement with Rezolute and a $0.8 million milestone earned pursuant to its Takeda Collaboration Agreement. XOMA did not recognize milestone revenue during the three months ended March 31, 2023.

Research and development ("R&D") expenses were $54,000 and $56,000, respectively, for the first quarters of 2023 and 2022.

General and administrative ("G&A") expenses were $6.2 million for the first quarter of 2023, compared to $5.1 million for the first quarter of 2022. The increase of $1.1 million for the three months ended March 31, 2023, as compared to the corresponding period of 2022, was primarily due to a $0.6 million increase in stock-based compensation expense and a $0.3 million increase in consulting and legal costs.

In the first quarter of 2023, the Company reported arbitration settlement costs of $4.1 million, consisting of the costs incurred related to the arbitration proceeding settlement with one of its licensees.

In the first quarter of 2023, G&A expenses included $1.6 million in non-cash stock-based compensation expense, compared with $1.0 million in the first quarter of 2022. XOMA’s net cash used in operating activities during the first quarter of 2023 was $4.9 million, as compared with $1.0 million during the first quarter of 2022.

The Company reported total other income, net, of $0.4 million in the first quarter of 2023, as compared to total other expense, net, of $0.2 million in the corresponding period of 2022. The $0.6 million variation between the corresponding quarters reflects a $0.4 million increase in investment income and a $0.2 million change in fair value of equity securities XOMA holds in Rezolute, Inc.

Net loss for the first quarter of 2023 was $9.8 million, compared to a net loss of $2.3 million for the first quarter of 2022.

On March 31, 2023, XOMA had cash and cash equivalents of $44.3 million and no debt on its balance sheet. On December 31, 2022, XOMA had cash and cash equivalents of $57.8 million. On January 17, 2023, the Company paid cash dividends on the 8.625% Series A Cumulative Perpetual Preferred Stock (Nasdaq: XOMAP) equal to $0.53906 per share and cash dividends on the 8.375% Series B Cumulative Perpetual Preferred Stock (Nasdaq: XOMAO) equal to $0.52344 per depositary share. In February 2023, XOMA received a cash payment from Roche, representing the second commercial payment from XOMA’s 0.5% commercial interest in the sales of Vabysmo. This payment is reflected in the Company’s condensed consolidated balance sheet as of March 31, 2023, as a reduction of short-term royalty and commercial payment receivables.

On May 9, 2023 Xilio Therapeutics, Inc. (Nasdaq: XLO), a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology therapies for people living with cancer, reported pipeline progress and business updates and reported financial results for the first quarter ended March 31, 2023 (Press release, Xilio Therapeutics, MAY 9, 2023, View Source [SID1234631302]).

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"In the first quarter, we continued to progress multiple clinical programs, notably with the recent initiation of our first Phase 2 clinical trial," said René Russo, Pharm.D., chief executive officer of Xilio. "The Phase 2 trial will assess the safety and efficacy of XTX202, our tumor-activated IL-2, in patients with advanced renal cell carcinoma and melanoma. To date, we have administered XTX202 in the outpatient setting at high dose levels and have not observed any of the severe systemic side effects commonly associated with recombinant IL-2. In addition, we plan to report preliminary data later this quarter from our Phase 1 clinical trial for XTX101, our tumor-activated, Fc-enhanced anti-CTLA-4."

Pipeline and Business Updates

XTX202: tumor-activated, engineered, beta-gamma biased IL-2

XTX202 is an investigational tumor-activated beta-gamma biased, engineered IL-2 molecule designed to potently stimulate CD8+ effector T cells and natural killer (NK) cells without concomitant stimulation of regulatory T cells when activated (unmasked) in the tumor microenvironment (TME). XTX202 is currently being evaluated in an ongoing Phase 1/2 clinical trial in patients with advanced solid tumors.

● Xilio recently initiated patient dosing at an initial dose of 1.4 mg/kg in a Phase 2 clinical trial evaluating XTX202 as a monotherapy in patients with unresectable or metastatic melanoma and metastatic renal cell carcinoma who have progressed on standard-of-care treatment.
● In addition, Xilio recently cleared the 1.4 mg/kg dose level (dose level five) in monotherapy dose-escalation (Part 1A) for the Phase 1 clinical trial and is currently dosing patients at the 2.8 mg/kg dose level (dose level six).
● A maximum tolerated dose has not yet been determined, and enrollment in Part 1A and Part 1B of the Phase 1 clinical trial is ongoing.
● Xilio anticipates reporting preliminary anti-tumor activity, safety, pharmacokinetic (PK) and pharmacodynamic (PD) data from the Phase 1/2 clinical trial in the third quarter of 2023. The company anticipates the reported data will include approximately 15-20 evaluable patients across a range of solid tumors treated at the 1 mg/kg dose or higher across all cohorts in the Phase 1/2 clinical trial.
XTX301: tumor-activated, engineered IL-12

XTX301 is an investigational tumor-activated, engineered IL-12 molecule designed to potently stimulate anti-tumor immunity and reprogram the TME of poorly immunogenic "cold" tumors towards an inflamed or "hot" state.

● Xilio has opened clinical trial sites and is actively screening patients for enrollment at a starting dose of 5.0 ug/kg (0.005 mg/kg) in monotherapy dose-escalation for its Phase 1 clinical trial evaluating the safety and tolerability of XTX301 in patients with advanced solid tumors.
● Xilio anticipates reporting preliminary safety data from the Phase 1 clinical trial into at least the third dose level in the fourth quarter of 2023.
XTX101: tumor-activated, Fc-enhanced anti-CTLA-4

XTX101, an investigational tumor-activated, Fc-enhanced, high affinity binding anti-CTLA-4, is currently being evaluated in monotherapy dose-expansion (Part 1B) of an ongoing Phase 1 clinical trial in patients with advanced solid tumors.

● Xilio reported the acceptance of an abstract highlighting preliminary Phase 1 data at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. Xilio plans to report additional preliminary Phase 1 safety, PK, PD, and anti-tumor activity data by the end of the second quarter of 2023.
● In addition, as previously announced, Xilio plans to continue to explore strategic opportunities to advance XTX101 with a partner beyond the current Phase 1 trial.
Upcoming Presentations and Accepted Abstracts

Xilio reported the acceptance of the following two abstracts at the 2023 ASCO (Free ASCO Whitepaper) Annual Meeting in Chicago, Illinois.

Xilio will present a trials-in-progress poster highlighting details of the Phase 1 clinical trial for XTX301:

● Presentation title: A first-in-human study of XTX301, a masked, tumor-activated interleukin-12 (IL-12), in patients with advanced solid tumors.
● Session date and time: June 3, 2023, 9:00 am to 12:00 pm EDT
● Abstract number: TPS2672
The following abstract highlighting preliminary safety, PK, and anti-tumor activity data from the Phase 1 clinical trial for XTX101 was accepted for inclusion in the 2023 ASCO (Free ASCO Whitepaper) Annual Meeting Proceedings, Journal of Clinical Oncology supplement:

● Presentation Title: Phase 1/2 study of XTX101, a masked, tumor-selective Fc-modified anti-CTLA-4, in patients with advanced solid tumors.
● Abstract number: e14685
First Quarter 2023 Financial Results

● Cash Position: Cash and cash equivalents were $93.3 million as of March 31, 2023, compared to $120.4 million as of December 31, 2022.
● Research & Development (R&D) Expenses: R&D expenses were $16.1 million for the quarter ended March 31, 2023, compared to $14.9 million for the quarter ended March 31, 2022. The increase was primarily driven by increased clinical development activities for XTX202, increased clinical development and manufacturing activities for XTX301, increased personnel-related costs, and increased costs related to the company’s earlier-stage programs. These increases were partially
offset by decreases in manufacturing activities for XTX202, preclinical development activities for XTX301 and clinical development activities for XTX101.
● General & Administrative (G&A) Expenses: G&A expenses were $7.4 million for the quarter ended March 31, 2023, compared to $6.3 million for the quarter ended and March 31, 2022. The increase was primarily driven by increased personnel-related costs and an increase in professional and consulting fees.
● Net Loss: Net loss was $22.6 million for the quarter ended March 31, 2023, compared to $21.4 million for the quarter ended March 31, 2022.
Financial Guidance

Xilio anticipates that its existing cash and cash equivalents will be sufficient to fund its operating expenses and capital expenditure requirements into the end of the second quarter of 2024.

About XTX202 (IL-2) and the Phase 1/2 Clinical Trial

XTX202 is an investigational tumor-activated beta-gamma biased, engineered IL-2 molecule designed to potently stimulate CD8+ effector T cells and natural killer (NK) cells without concomitant stimulation of regulatory T cells when activated (unmasked) in the tumor microenvironment (TME). The Phase 1 clinical trial for XTX202 is a first-in-human, multi-center, open-label trial designed to evaluate the safety and tolerability of XTX202 as a monotherapy in patients with advanced solid tumors. The Phase 2 clinical trial for XTX202 is a multi-center, open-label trial designed to evaluate the safety and efficacy of XTX202 as a monotherapy in patients with unresectable or metastatic melanoma and metastatic renal cell carcinoma who have progressed on standard-of-care treatment. Please refer to NCT05052268 on www.clinicaltrials.gov for additional details.

About XTX301 (IL-12) and the Phase 1 Clinical Trial

XTX301 is an investigational tumor-activated, engineered IL-12 molecule designed to potently stimulate anti-tumor immunity and reprogram the tumor microenvironment (TME) of poorly immunogenic "cold" tumors towards an inflamed or "hot" state. The Phase 1 clinical trial for XTX301 is a first-in-human, multi-center, open-label trial designed to evaluate the safety and tolerability of XTX301 as a monotherapy in patients with advanced solid tumors. Please refer to NCT05684965 on www.clinicaltrials.gov for additional details.

About XTX101 (anti-CTLA-4) and the Phase 1 Clinical Trial

XTX101 is an investigational tumor-activated, Fc-enhanced, high affinity binding anti-CTLA-4 monoclonal antibody designed to deplete regulatory T cells when activated (unmasked) in the tumor microenvironment (TME). The Phase 1 clinical trial is a first-in-human, multi-center, open-label trial designed to evaluate the safety and tolerability of XTX101 for the treatment of adult patients with advanced solid tumors. Please refer to NCT04896697 on www.clinicaltrials.gov for additional details.

On May 9, 2023 Verrica Pharmaceuticals Inc. ("Verrica" or "the Company") (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, reported financial results for the first quarter ended March 31, 2023 (Press release, Verrica Pharmaceuticals, MAY 9, 2023, View Source [SID1234631301]).

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"The first quarter of 2023 saw continued execution across our pipeline and strengthening of our financial position," said Ted White, Verrica’s President and Chief Executive Officer. "With the upcoming PDUFA goal date of July 23, we may be poised to reach a major inflection point with the potential approval of YCANTH for the treatment of molluscum contagiosum. Molluscum is a dermatological condition that afflicts millions of children each year in the U.S., and with no FDA approved therapies, we believe YCANTH has the potential to address this significant unmet medical need. We also made progress with our novel oncolytic peptide, VP-315, which advanced into the second part of our ongoing Phase 2 study in basal cell carcinoma in April 2023 following a positive safety assessment and promising signs of activity from Part 1 of the study.

"We also had the opportunity to strengthen our balance sheet during the quarter, raising an additional $32.5 million in gross proceeds in an underwritten offering to further extend our cash runway. This additional capital will help support our pre-commercial activities for YCANTH and fund our ongoing VP-315 Phase 2 study. Looking ahead, we are excited about the progress we expect to make throughout the remainder of the year."

Business Highlights and Recent Developments

VP-102

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On February 27, 2023, the U.S. Food and Drug Administration (FDA) assigned a Prescription Drug User Fee Act (PDUFA) of July 23, 2023, for Verrica’s New Drug Application (NDA) for YCANTH (VP-102), which is being developed for the treatment of molluscum contagiosum (molluscum).

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On January 4, 2023, Verrica announced the successful completion of the technology transfer of bulk solution manufacturing of YCANTH to Piramal Pharma Solutions. The technology transfer includes the completion of the registration batch material, which has been placed on stability, and the manufacture of three process validation batches of bulk solution.

VP-315

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On April 12, 2023, Verrica announced that the first patient has been dosed in Part 2 of a Phase 2 study evaluating the Company’s potentially first-in-class oncolytic peptide, VP-315, for the treatment of basal cell carcinoma. Part 2 of the Phase 2 trial is designed to further explore dosing regimens to identify the recommended dose for Part 3 of the study, which is expected to start in the first half of 2024.

Underwritten Offering

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On February 21, 2023, the Company announced the pricing of a $32.5 million underwritten offering of common stock and pre-funded warrants.

Financial Results

First Quarter 2023 Financial Results

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Verrica recognized collaboration revenues of $37,000 in the first quarter of 2023 compared to $0.4 million for the same period in 2022 related to the Collaboration and License Agreement with Torii Pharmaceutical Col, Ltd ("Torii"). The collaboration revenue consists of supplies and development activity with Torii.

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Research and development expenses were $2.7 million in the first quarter of 2023, compared to $2.4 million for the same period in 2022. The increase was primarily attributable to additional CMC costs related to our development of VP-102 for molluscum.

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General and administrative expenses were $4.3 million in the first quarter of 2023, compared to $5.1 million for the same period in 2022. The decrease was primarily related to lower compensation costs due to a reduction in headcount.

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Costs of collaboration revenue were $68,000 for the first quarter of 2023, compared to $0.3 million for the same period in 2022. The decrease of $0.2 million was primarily due to less manufacturing supply required to support development and testing services pursuant to the Torii Clinical Supply Agreement.

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For the first quarter of 2023, net loss on a GAAP basis was $6.6 million, or $0.15 per share, compared to a net loss of $8.5 million, or $0.31 per share, for the same period in 2022.

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For the first quarter of 2023, non-GAAP net loss was $5.5 million, or $0.13 per share, compared to a non-GAAP net loss of $6.8 million, or $0.25 per share, for the same period in 2022.

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As of March 31, 2023, Verrica had aggregate cash and cash equivalents of $60.0 million. The Company believes that its existing cash and cash equivalents as of March 31, 2023, will be sufficient to support planned operations into the first quarter of 2024.

Non-GAAP Financial Measures

In evaluating the operating performance of its business, Verrica’s management considers non-GAAP loss from operations, non-GAAP net loss and non-GAAP net loss per share. These non-GAAP financial measures exclude stock-based compensation charges and non-cash interest expense that are required by GAAP. Verrica believes that non-GAAP loss from operations, non-GAAP net loss and non-GAAP net loss per share provides useful information to both management and investors by excluding the effect of certain non-cash expenses and items that Verrica believes may not be indicative of its operating performance, because either they are unusual and Verrica does not expect them to recur in the ordinary course of its business, or they are unrelated to the ongoing operation of the business in the ordinary course. Non-GAAP loss from operations, non-GAAP net loss and non-GAAP net loss per share should be considered in addition to results prepared in accordance with GAAP, but should not be considered a substitute for, or superior to, GAAP results. Non-GAAP loss from operations, non-GAAP net loss and non-GAAP net loss per share have been reconciled to the nearest GAAP measure in the tables following the financial statements in this press release.

About YCANTH (VP-102)

YCANTH (VP-102) is a proprietary drug-device combination product that contains a GMP-controlled formulation of cantharidin delivered via a single-use applicator that allows for precise topical dosing and targeted administration for the treatment of molluscum. If approved, YCANTH would be the only product approved by the FDA to treat molluscum — a common, highly contagious skin disease that affects an estimated six million people in the United States, primarily children. In addition, Verrica has successfully completed a Phase 2 study of VP-102 for the treatment of common warts and a Phase 2 study of VP-102 for the treatment of external genital warts.

About VP-315

VP-315 is a potentially first-in-class oncolytic peptide immunotherapy in development as a non-surgical treatment option for non-melanoma skin cancers. The Phase 2 trial is a three-part, open-label, multicenter, dose-escalation, proof-of-concept study with a safety run-in designed to assess the safety, pharmacokinetics, and efficacy of VP-315 when administered intratumorally to adults with biopsy-proven basal cell carcinoma. The study is expected to enroll approximately 66 adult subjects with a histological diagnosis of basal cell carcinoma in at least one eligible target lesion.

Forward-Looking Statements

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe," "expect," "may," "plan," "potential," "will," and similar expressions, and are based on Verrica’s current beliefs and expectations. These forward-looking statements include expectations regarding the

approval of VP-102 for the treatment of molluscum, the timing of clinical trial completion for VP-315 and Verrica’s cash and cash equivalents being sufficient to support planned operations into the first quarter of 2024. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the drug development process and the regulatory approval process, Verrica’s reliance on third parties over which it may not always have full control and uncertainties that are described in Verrica’s Annual Report on Form 10-K for the year ended December 31, 2022 and other filings Verrica makes with the U.S. Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and are based on information available to Verrica as of the date of this release, and Verrica assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

On May 9, 2023 Syros Pharmaceuticals (NASDAQ:SYRS), a biopharmaceutical company committed to advancing new standards of care for the frontline treatment of hematologic malignancies, reported that its Chief Executive Officer, Nancy Simonian, M.D., will participate in a fireside chat at the JMP Securities 2023 Life Sciences Conference (Press release, Syros Pharmaceuticals, MAY 9, 2023, View Source [SID1234631300]). Management will also be available for one-on-one meetings. Details are as follows:

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JMP Securities 2023 Life Sciences Conference

Date: Tuesday, May 16
Time: 10:00 a.m. ET
Location: The New York Hilton Midtown, 1335 Avenue of the Americas, New York, NY

A live webcast of the fireside chat will be available on the Investors & Media section of the Syros website at www.syros.com. An archived replay of the webcast will be available for approximately 30 days following the presentation.

On May 9, 2023, Madrigal Pharmaceuticals, Inc. (the "Company") reported to have entered into Amendment No. 1 (the "Amendment") to the Sales Agreement dated June 1, 2021 (as amended, the "Sales Agreement") with Cowen and Company, LLC ("Cowen"), which Amendment increases by up to an additional $200,000,000 the amount of the Company’s common stock, par value $0.0001 per share (the "Common Stock") that can be issued and sold by the Company from time to time through or to Cowen, acting as agent or principal (the "ATM Offering") (Filing, 8-K, Madrigal Pharmaceuticals, MAY 9, 2023, View Source [SID1234631299]).

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Sales of the Common Stock, if any, under the Sales Agreement will be made by any method that is deemed to be an "at the market" offering as defined in Rule 415(a)(4) of the Securities Act of 1933, as amended. The Company has no obligation to sell any of the Common Stock and may at any time suspend offers under the Sales Agreement or terminate the Sales Agreement pursuant to its terms.

Subject to the terms and conditions of the Sales Agreement, Cowen will use its commercially reasonable efforts to sell the shares of Common Stock from time to time, as the sales agent, based upon the Company’s instructions. The offering of shares of Common Stock pursuant to the Sales Agreement will terminate upon the earlier of (i) the sale of all Common Stock subject to the Sales Agreement or (ii) the termination of the Sales Agreement in accordance with its terms.

The foregoing description of Amendment to the Sales Agreement does not purport to be complete and is qualified in its entirety by reference to the complete text of the Amendment, a copy of which is incorporated herein by reference as Exhibit 1.1.

The Common Stock to be sold under the Sales Agreement, if any, will be issued and sold pursuant to the Company’s automatic shelf registration statement on Form S-3 (File No. 333-256666), filed with the Securities and Exchange Commission ("SEC") on June 1, 2021. On May 9, 2023, the Company filed a prospectus supplement with the SEC in connection with the offer and sale of the additional $200,000,000 of Common Stock pursuant to the Amendment to the Sales Agreement. This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy the Common Stock nor shall there be any sale of the Common Stock in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction. The legal opinion of Hogan Lovells US LLP relating to the legality of the issuance and sale of the Common Stock pursuant to the ATM Offering is attached as Exhibit 5.1 to this Current Report on Form 8-K and is incorporated by reference herein.