Vidutolimod

FPI-1434 Phase 1 data on track to be reported in first half of 2023 Phase 1/2 Study of FPI-1966 open and enrolling patients with solid tumors expressing FGFR3 Strong balance sheet with $205.5 million in cash, cash equivalents and investments with runway into Q3 2024 HAMILTON, ON and BOSTON, Nov. 8, 2022 /PRNewswire/ -- Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced financial results for the third quarter ended September 30, 2022 and provided an update on clinical and corporate developments. Chief Executive Officer John Valliant, Ph.D. commented, "During the third quarter of 2022, we continued to advance our pipeline of targeted alpha therapy programs to treat multiple cancer types not currently addressed by available radiopharmaceutical therapies. Leveraging our platform and radiopharmaceutical expertise, we now have three Phase 1 clinical programs. Our lead program, FPI-1434, remains on track to report Phase 1 data in the first half of 2023. Following the initiation of dosing in our Phase 1/2 study of FPI-1966, we have opened multiple study sites and are actively recruiting patients with FGFR3-expressing solid tumors. We also continue to make progress in our newest clinical program, FPI-2059, which, based on clinical imaging and preclinical data, we believe has the potential to precisely target and kill tumor cells in colorectal, pancreatic and neuroendocrine prostate cancers. Furthermore, we've demonstrated Fusion's proficiency in targeted alpha therapy (TAT) development with the first candidate under our collaboration agreement with AstraZeneca moving promptly through investigational new drug (IND) enabling studies. Our rich pipeline of cancer therapies is underpinned by an experienced internal radiopharmaceutical R&D team, and early investments in actinium supply, bolstered by our manufacturing capabilities. We look forward to providing meaningful updates on our diverse and growing pipeline of TATs in the months ahead." Portfolio Update FPI-1434 In the Phase 1 study, Fusion is exploring various dose levels of FPI-1434 as well as two dosing regimens: one with FPI-1434 alone, and another in which a small dose of cold antibody (naked IGF-1R antibody without the isotope) is administered prior to each dose of FPI-1434. The Company anticipates reporting Phase 1 safety, pharmacokinetics, and imaging data, including any evidence of anti-tumor activity, and details on the dosing regimen, in the first half of 2023. Fusion continues to anticipate the initiation of a Phase 1 combination study with FPI-1434 and KEYTRUDA® (pembrolizumab) to occur six to nine months following determination of the recommended Phase 2 dose of FPI-1434 monotherapy. FPI-1966 The Phase 1, non-randomized, open-label clinical trial of FPI-1966 in patients with solid tumors expressing FGFR3 is intended to investigate safety, tolerability and pharmacokinetics and to establish the recommended Phase 2 dose. Patient enrollment and dosing is ongoing. The company plans to provide updated guidance for preliminary pharmacokinetic, imaging and safety data from the first patient cohort following experience with patient screening in order to better predict the cadence of patient enrollment. FPI-2059 FPI-2059 is a small molecule radioconjugate in development as a targeted alpha therapy for various solid tumors, including neuroendocrine differentiated (NED) prostate, colorectal, and pancreatic cancers. The molecule targets neurotensin receptor 1 (NTSR1), a promising target for cancer treatment, which is overexpressed in several solid tumors. FPI-2059 is based upon Ipsen's IPN-1087 (previously studied in a Phase 1 clinical trial as a beta-emitting radiopharmaceutical), which Fusion acquired in 2021, and converted to an alpha-emitting radiopharmaceutical using actinium-225. The U.S. Food and Drug Administration (FDA) cleared Fusion's IND application for FPI-2059 in June 2022 and study initiation activities are ongoing in a Phase 1, non-randomized, open-label clinical trial in patients with solid tumors expressing NTSR1, intended to investigate safety, tolerability and pharmacokinetics and to establish the recommended Phase 2 dose. Fusion plans to provide guidance on timelines for the FPI-2059 program following site activations and initial experience with patient screening and patient enrollment. Recent Updates In August, Fusion announced first patient dosed in Phase 1/2 study of FPI-1966 in patients with advanced solid tumors expressing FGFR3. The Phase 1/2 multi-center, open-label clinical trial is designed to investigate the safety, tolerability, dosimetry, biodistribution, and pharmacokinetics of FPI-1966 in patients with FGFR3-expressing advanced, inoperable, metastatic, and/or recurrent solid tumors. The study employs a 3 + 3 dose escalation design to evaluate multiple ascending doses of FPI-1966. The first cohort will comprise sub-groups in which various doses of non-radiolabeled vofatamab ("cold antibody") will be evaluated to assess the impact of pre-dosing on tumor uptake and pharmacokinetics. As part of the trial, patients will be administered an imaging analogue of FPI-1966, FPI-1967, and only those who upon imaging meet predefined tumor uptake will go on to receive FPI-1966. The Phase 2 portion of the study will consist of two tumor-specific cohorts and one basket cohort. In September, Fusion drew down $25 million under the previously announced debt agreement with Oxford Finance LLC. To date, the Company has drawn down a total of $35 million. The loan agreement, as amended, provides for up to four tranches totaling $75 million. With the additional $25 million in debt funding, Fusion now expects its cash, cash equivalents and investments will be sufficient to fund operations into the third quarter of 2024. On November 7, Fusion announced the appointment of Dmitri Bobilev, M.D., as chief medical officer. Dr. Bobilev joins Fusion from Checkmate Pharma, where he was vice president, head of clinical development until the company's acquisition by Regeneron earlier in 2022. At Checkmate, he was responsible for clinical development and registration strategy for vidutolimod. Third Quarter 2022 Financial Results Cash and Investments: As of September 30, 2022, Fusion held cash, cash equivalents and investments of $205.5 million, compared to cash, cash equivalents and investments of $220.8 million as of December 31, 2021. Fusion expects its existing cash, cash equivalents and investments as of September 30, 2022, will be sufficient to fund operations into the third quarter of 2024. Collaboration Revenue: For the third quarter of 2022, Fusion recorded $0.2 million of revenue under the AstraZeneca collaboration agreement. R&D Expenses: Research and development expenses for the third quarter of 2022 were $16.6 million, compared to $12.7 million for the same period in 2021. The increase was primarily due to discrete items that occurred during the third quarter of 2022, including a common share issuance and cash payment pursuant to our asset purchase agreement to acquire vofatamab from Rainier Therapeutics. Additionally, there was an increase in direct costs related to FPI-2059, specifically related to the initiation of the Phase 1 clinical trial as well as preclinical research and manufacturing costs. G&A Expenses: General and administrative expenses for the third quarter of 2022 were $7.4 million, compared to $7.2 million for the same period in 2021. The increase was primarily due to an increase in personnel-related costs, partially offset by a decrease in corporate costs and professional fees. Net Loss: For the third quarter of 2022, Fusion reported a net loss of $24.0 million, or $0.55 per share, compared with a net loss of $19.4 million, or $0.45 per share, for the same period in 2021. About Fusion Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules to selectively deliver the alpha emitting payloads to tumors. Fusion's first program, FPI-1434 targeting insulin-like growth factor 1 receptor (IGF-1R), is currently in a Phase 1 clinical trial. The pipeline includes FPI-1966, targeting the fibroblast growth factor receptor 3 (FGFR3), currently in a Phase 1 study; and FPI-2059, a small molecule targeting neurotensin receptor 1 (NTSR1), which has received FDA investigational new drug (IND) clearance and will begin a Phase 1 study. In addition to a robust proprietary pipeline, Fusion has a collaboration with AstraZeneca to jointly develop novel targeted alpha therapies (TATs) and combination programs between Fusion's TATs and AstraZeneca's DNA Damage Repair Inhibitors (DDRis) and immuno-oncology agents. Fusion has also entered into a collaboration with Merck to evaluate FPI-1434 in combination with Merck's KEYTRUDA® (pembrolizumab) in patients with solid tumors expressing IGF-1R. To support Fusion's growing pipeline of TATs, the company has signed strategic agreements for actinium supply with both TRIUMF and Niowave, Inc. Forward-Looking Statements This press release contains "forward-looking statements" for purposes of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995, including but not limited to the statements regarding Fusion Pharmaceuticals Inc.'s (the "Company") future business and financial performance. For this purpose, any statements contained herein that are not statements of historical fact may be deemed forward-looking statements. Without limiting the foregoing, the words "expect," "plans," "anticipates," "intends," "will," and similar expressions are also intended to identify forward-looking statements, as are expressed or implied statements with respect to the Company's potential drug candidates, including any expressed or implied statements regarding the successful development of its product candidates. Actual results may differ materially from those indicated by such forward-looking statements as a result of risks and uncertainties, including but not limited to the following: there can be no guarantees that the Company will advance any clinical product candidate or other component of its potential pipeline to the clinic, to the regulatory process or to commercialization; management's expectations could be affected by unexpected patient recruitment delays or regulatory actions or delays; uncertainties relating to, or unsuccessful results of, clinical trials, including additional data relating to the ongoing clinical trials evaluating its product candidates; the Company's ability to obtain additional funding required to conduct its research, development and commercialization activities; changes in the Company's business plan or objectives; the ability of the Company to attract and retain qualified personnel; competition in general; and the Company's ability to obtain, maintain and enforce patent and other intellectual property protection for its product candidates and its discoveries. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. These and other risks which may impact management's expectations are described in greater detail under the heading "Risk Factors" in the Company's quarterly report on Form 10-Q for the quarter ended June 30, 2022, as filed with the SEC and in any subsequent periodic or current report that the Company files with the SEC. All forward-looking statements reflect the Company's estimates only as of the date of this release (unless another date is indicated) and should not be relied upon as reflecting the Company's views, expectations or beliefs at any date subsequent to the date of this release. While Fusion may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, even if the Company's estimates change. Investors and others should note that Fusion communicates with its investors and the public using the Fusion website, , including, but not limited to, company disclosures, investor presentations, SEC filings, and press releases. The information that Fusion posts on this website could be deemed to be material information. As a result, Fusion encourages investors, media and others interested to review the information that Fusion posts there on a regular basis. Contact: Amanda Cray Senior Director of Investor Relations & Corporate Communications (617) 967-0207 [email protected] SOURCE Fusion Pharmaceuticals Inc.

Received first recurring royalty-style payment from Roche related to faricimab, its newly launched therapy for wet age-related macular degeneration (wAMD) and diabetic macular edema (DME). First five months of sales in the U.S. and initial sales in Japan resulted in a $0.5 million cash payment to XOMA. Paid $3.0 million milestone to Affitech S.A. triggered by the European Commission’s approval of Roche’s VABYSMO® (faricimab-svoa) for the treatment of wAMD and DME. Received $2.5 million milestone payment from Kuros triggered by the completion of Regeneron’s acquisition of Checkmate Pharmaceuticals. Ended the third quarter of 2022 with cash of $78.3 million and no debt on its balance sheet. EMERYVILLE, Calif., Nov. 03, 2022 (GLOBE NEWSWIRE) -- XOMA Corporation (Nasdaq: XOMA), a biotech royalty aggregator playing a distinctive role in helping biotech companies achieve their goal of advancing novel therapeutic candidates aimed at improving human health, reported its third quarter 2022 financial results and provided a recent operations update. “The third quarter was a turning point for XOMA as a royalty and milestone aggregator. Less than one year after we acquired the 0.5% economic interest in VABYSMO® sales, we have received our first commercial payment from Roche. The therapy is now available to retinal specialists and their patients in three important markets - the U.S., EU, and Japan,” stated Jim Neal, Chairman and Chief Executive Officer of XOMA. “Separately, as a result of a monetization transaction we closed in 2021 with Kuros Biosciences associated with vidutolimod, which was being developed by Checkmate Pharmaceuticals, we received a $2.5 million payment as Regeneron completed its acquisition of Checkmate. We look forward to additional business and clinical milestone achievements from our partners as they advance their assets.” Financial Results XOMA recorded total revenues of $0.5 million for the third quarter of 2022 and $0.9 million for the third quarter of 2021. The decrease for the three months ended September 30, 2022, as compared to the same period in 2021, was primarily due to $0.5 million of milestone revenue recognized in the third quarter of 2021 under XOMA’s license agreement with Compugen. Research and development (“R&D”) expenses were $29,000 and $30,000, respectively, for the third quarters of 2022 and 2021. General and administrative (“G&A”) expenses were $4.8 million for the third quarter of 2022, compared to $4.3 million for the third quarter of 2021. The additional $0.5 million during the third quarter of 2022 reflects increased consulting and legal expenses associated with deal costs. In the third quarter of 2022, G&A expenses included $0.8 million in non-cash stock-based compensation expense, which was consistent with the third quarter of 2021. XOMA’s net cash used in operations in the third quarter of 2022 was $3.7 million, as compared with $3.1 million during the third quarter of 2021. Other income, net was $0.2 million for the third quarter of 2022, compared to other expense, net of $1.1 million in the corresponding quarter of 2021. The fluctuation in other income (expense), net between the quarters ended September 30, 2022 and 2021, is primarily due to the change in the fair value of equity securities XOMA holds in Rezolute, Inc. Net loss for the third quarter of 2022 was $4.2 million, compared to net loss of $4.4 million for the third quarter of 2021. On September 30, 2022, XOMA had cash of $78.3 million. In August 2022, XOMA received a $0.5 million cash payment from Roche, representing the first commercial payment for XOMA’s 0.5% commercial interest in the sales of VABYSMO® (faricimab-svoa). The payment was recorded in the Company’s condensed consolidated balance sheet as of September 30, 2022, as a reduction of long-term royalty and commercial payment receivables. On October 17, 2022, 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. The Company ended December 31, 2021, with cash and restricted cash of $95.4 million. After paying its remaining debt obligations in the second quarter of 2021, XOMA has no debt on its balance sheet. The Company continues to believe its current cash position will be sufficient to fund XOMA’s operations for multiple years. About XOMA Corporation XOMA is a biotechnology royalty aggregator playing a distinctive role in helping biotech companies achieve their goal of improving human health. XOMA acquires the potential future economics associated with pre-commercial therapeutic candidates that have been licensed to pharmaceutical or biotechnology companies. When XOMA acquires the future economics, the seller receives non-dilutive, non-recourse funding they can use to advance their internal drug candidate(s) or for general corporate purposes. The Company has an extensive and growing portfolio with more than 70 assets (asset defined as the right to receive potential future economics associated with the advancement of an underlying therapeutic candidate). For more information about the Company and its portfolio, please visit Forward-Looking Statements/Explanatory Notes Certain statements contained in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including statements regarding the timing and amount of potential commercial payments to XOMA and other developments related to VABYSMO® (faricimab-svoa), the potential of XOMA’s portfolio of partnered programs and licensed technologies generating substantial milestone and royalty proceeds over time, and XOMA’s cash sufficiency forecast. In some cases, you can identify such forward-looking statements by terminology such as “anticipate,” “intend,” “believe,” “estimate,” “plan,” “seek,” “project,” “expect,” “may,” “will”, “would,” “could” or “should,” the negative of these terms or similar expressions. These forward-looking statements are not a guarantee of XOMA’s performance, and you should not place undue reliance on such statements. These statements are based on assumptions that may not prove accurate, and actual results could differ materially from those anticipated due to certain risks inherent in the biotechnology industry, including those related to the fact that our product candidates subject to out-license agreements are still being developed, and our licensees may require substantial funds to continue development which may not be available; we do not know whether there will be, or will continue to be, a viable market for the products in which we have an ownership or royalty interest; if the therapeutic product candidates to which we have a royalty interest do not receive regulatory approval, our third-party licensees will not be able to market them; and the impact to the global economy as a result of the COVID-19 pandemic. Other potential risks to XOMA meeting these expectations are described in more detail in XOMA's most recent filing on Form 10-Q and in other filings with the Securities and Exchange Commission. Consider such risks carefully when considering XOMA's prospects. Any forward-looking statement in this press release represents XOMA's beliefs and assumptions only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. XOMA disclaims any obligation to update any forward-looking statement, except as required by applicable law. EXPLANATORY NOTE: Any references to “portfolio” in this press release refer strictly to milestone and/or royalty rights associated with a basket of drug products in development. Any references to “assets” in this press release refer strictly to milestone and/or royalty rights associated with individual drug products in development. As of the date of this press release, all assets in XOMA’s milestone and royalty portfolio, except faricimab, are investigational compounds. Efficacy and safety have not been established. There is no guarantee that any of the investigational compounds will become commercially available. XOMA CORPORATION CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (unaudited) (in thousands, except per share amounts) Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Revenues: Revenue from contracts with customers $ 25 $ 550 $ 3,300 $ 1,094 Revenue recognized under units-of-revenue method 426 390 1,241 1,121 Total revenues 451 940 4,541 2,215 Operating expenses: Research and development 29 30 125 129 General and administrative 4,794 4,255 15,620 14,922 Total operating expenses 4,823 4,285 15,745 15,051 Loss from operations (4,372 ) (3,345 ) (11,204 ) (12,836 ) Other income (expense), net: Interest expense - - - (461 ) Loss on extinguishment of debt - - - (300 ) Other income (expense), net 194 (1,091 ) 76 (449 ) Net loss and comprehensive loss $ (4,178 ) $ (4,436 ) $ (11,128 ) $ (14,046 ) Less: accumulated dividends on Series A and Series B preferred stock (1,368 ) (1,368 ) (4,104 ) (3,192 ) Net loss available to common stockholders, basic and diluted $ (5,546 ) $ (5,804 ) $ (15,232 ) $ (17,238 ) Basic and diluted net loss per share available to common stockholders $ (0.48 ) $ (0.51 ) $ (1.34 ) $ (1.53 ) Weighted average shares used in computing basic and diluted net loss per share available to common stockholders 11,447 11,311 11,400 11,279 XOMA CORPORATION CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited) (in thousands, except share and per share amounts) September 30, December 31, 2022 2021 ASSETS Current assets: Cash and cash equivalents $ 78,285 $ 93,328 Restricted cash - 2,049 Short-term equity securities 443 774 Trade and other receivables, net 16 209 Prepaid expenses and other current assets 997 613 Total current assets 79,741 96,973 Property and equipment, net 8 13 Operating lease right-of-use assets 73 200 Long-term royalty and commercial payment receivables 66,049 69,075 Other assets - long term 260 301 Total assets $ 146,131 $ 166,562 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable $ 985 $ 1,072 Accrued and other liabilities 1,208 525 Income taxes payable - 91 Contingent consideration under royalty purchase agreements and commercial purchase payment agreements 75 8,075 Operating lease liabilities 85 195 Unearned revenue recognized under units-of-revenue method 1,704 1,641 Preferred stock dividend accrual 1,368 1,368 Total current liabilities 5,425 12,967 Unearned revenue recognized under units-of-revenue method – long-term 10,381 11,685 Long-term operating lease liabilities - 34 Total liabilities 15,806 24,686 Stockholders’ equity: Preferred Stock, $0.05 par value, 1,000,000 shares authorized: 8.625% Series A cumulative, perpetual preferred stock, 984,000 shares issued and outstanding at September 30, 2022 and December 31, 2021 49 49 8.375% Series B cumulative, perpetual preferred stock, 1,600 shares issued and outstanding at September 30, 2022, and December 31, 2021 — — Convertible preferred stock, 5,003 issued and outstanding at September 30, 2022, and December 31, 2021 — — Common stock, $0.0075 par value, 277,333,332 shares authorized, 11,450,823 and 11,315,263 shares issued and outstanding at September 30, 2022, and December 31, 2021, respectively 86 85 Additional paid-in capital 1,306,606 1,307,030 Accumulated deficit (1,176,416 ) (1,165,288 ) Total stockholders’ equity 130,325 141,876 Total liabilities and stockholders’ equity $ 146,131 $ 166,562 Investor contact: Juliane Snowden XOMA +1-646-438-9754 juliane.snowden@xoma.com Media contact: Kathy Vincent KV Consulting & Management +1-310-403-8951 kathy@kathyvincent.com