1. HAMILTON, ON and BOSTON, Sept. 2, 2021 /PRNewswire/ -- Fusion Pharmaceuticals Inc. (NASDAQ:FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced that the Company will participate in two upcoming virtual investor conferences.

    • The Morgan Stanley 19th Annual Global Healthcare Conference – The fireside chat will take place on Thursday, September 9, 2021 at 11:00am ET. Presenting on behalf of Fusion will be Chief Executive Officer John Valliant, Ph.D., and Chief Financial Officer John Crowley.



    • The H.C. Wainwright 23rd Annual Global Investment Conference – A recording of the presentation will be made available for on-demand viewing on Monday, September 13, at 7:00am ET. Presenting on behalf of Fusion will be Chief Executive Officer John Valliant, Ph.D.

    Webcasts of each event will be available on the "Events and Presentations" page in the "Investors & Media" section of the Company's website at https://ir.fusionpharma.com/events-webcasts. Replays of the webcasts will be archived on the Company's website for 90 days following their respective presentation dates.  

    About Fusion

    Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Employing a proprietary Fast-Clear™ linker technology, Fusion connects alpha particle emitting isotopes to various targeting molecules in order to selectively deliver the alpha emitting payloads to tumors. Fusion's lead program, FPI-1434 targeting insulin-like growth factor 1 receptor, is currently in a Phase 1 clinical trial. The pipeline includes FPI-1966, targeting the fibroblast growth factor receptor 3 (FGFR3), advancing to a Phase 1 study following the recent investigational new drug (IND) clearance; and FPI-2059, a small molecule targeting neurotensin receptor 1 (NTSR1). 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. Fusion and Hamilton, Ontario-based McMaster University are building a current Good Manufacturing Practice (GMP) compliant radiopharmaceutical manufacturing facility designed to support manufacturing of the Company's growing pipeline of TATs.

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    SOURCE Fusion Pharmaceuticals Inc.

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  2. HAMILTON, Ontario and BOSTON, Aug. 31, 2021 /PRNewswire/ -- Fusion Pharmaceuticals Inc. (NASDAQ:FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced that the compensation committee of the Company's Board of Directors granted stock option awards to purchase an aggregate of 80,000 shares of its common stock to one employee outside Fusion's 2020 Stock Option and Incentive Plan. The stock options were granted as an inducement material to the individual becoming an employee of Fusion in accordance with Nasdaq Listing Rule 5635(c)(4).

    The options have an exercise price of $9.41 per share, which is equal to the closing price of Fusion's common stock on August 30, 2021. Each option has a ten-year term and vests over four years, with 25% of the original number of shares vesting on the one-year anniversary of the grant date and then in equal installments for 36 months thereafter, subject to the employee's continued service with Fusion through the applicable vesting dates.

    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 targeting molecules in order to selectively deliver the alpha emitting payloads to tumors. Fusion's lead program, FPI-1434, is currently in a Phase 1 clinical trial. The Company is advancing a pipeline of targeted radiopharmaceutical cancer therapies for a broad array of tumor types based upon its proprietary platform which includes internal research and development capabilities, manufacturing and supply chain expertise, and the Company's proprietary Fast-Clear™ linker technology.

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/fusion-pharmaceuticals-announces-inducement-grants-under-nasdaq-listing-rule-5635c4-301366537.html

    SOURCE Fusion Pharmaceuticals Inc.

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  3. Fusion and TRIUMF to collaborate to produce actinium based on technology developed by TRIUMF

    HAMILTON, ON and BOSTON and VANCOUVER, BC, Aug. 12, 2021 /PRNewswire/ -- Fusion Pharmaceuticals Inc. (NASDAQ:FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, and TRIUMF, Canada's particle accelerator centre, today announced that the companies have entered into the next phase of their collaboration agreement for the development, production, and supply of actinium-225. Fusion will provide to TRIUMF funding to further develop technology to produce actinium-225 and in return Fusion will have rights, including preferred access and pricing, to the resulting alpha-emitting medical…

    Fusion and TRIUMF to collaborate to produce actinium based on technology developed by TRIUMF

    HAMILTON, ON and BOSTON and VANCOUVER, BC, Aug. 12, 2021 /PRNewswire/ -- Fusion Pharmaceuticals Inc. (NASDAQ:FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, and TRIUMF, Canada's particle accelerator centre, today announced that the companies have entered into the next phase of their collaboration agreement for the development, production, and supply of actinium-225. Fusion will provide to TRIUMF funding to further develop technology to produce actinium-225 and in return Fusion will have rights, including preferred access and pricing, to the resulting alpha-emitting medical isotope.

    "As we advance our growing pipeline of actinium-based targeted alpha therapies (TATs), we are focused on expanding our manufacturing capabilities and continuing to proactively address and prioritize actinium supply. This supports our strategic plans to develop differentiated radiopharmaceuticals to treat a broad range of cancers with high unmet medical need," said Fusion Chief Executive Officer John Valliant, Ph.D. "We are excited to expand our collaborative relationship with TRIUMF, a leader in isotope production, marking an important step to further expand actinium-225 production and supply."

    "Through its TAT platform technology, Fusion has the opportunity to unlock the full potential of actinium, an alpha-emitting isotope with the ability to deliver a potent, highly localized payload to cancer cells, " said TRIUMF Innovations CEO, Kathryn Hayashi. "With this next phase, we are solidifying our partnership with a premier developer of innovative actinium radiopharmaceuticals to deepen TRIUMF's leadership position in isotope production and impact the cancer treatment landscape."

    TRIUMF Director and CEO, Nigel Smith, Ph.D. added, "This marks an important milestone in the existing collaboration between Fusion and TRIUMF. Our partnership is generating new ideas and innovations that validate the important role TRIUMF has at the forefront of the global medical isotope ecosystem. Together TRIUMF and Fusion are laying the groundwork for major breakthroughs that will benefit the lives of countless patients around the world."

    In December 2020, Fusion and TRIUMF entered a collaboration and supply agreement to develop, produce and procure the supply of actinium-225 to Fusion. As part of this agreement, Fusion will continue its investment of up to $25 million (CAD) in TRIUMF to advance technology and processes for actinium-225 production.

    About Fusion

    Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Employing a proprietary Fast-Clear™ linker technology, Fusion connects alpha particle emitting isotopes to various targeting molecules in order to selectively deliver the alpha emitting payloads to tumors. Fusion's lead program, FPI-1434 targeting insulin-like growth factor 1 receptor, is currently in a Phase 1 clinical trial. The pipeline includes FPI-1966, targeting the fibroblast growth factor receptor 3 (FGFR3); and FPI-2059, a small molecule targeting neurotensin receptor 1 (NTSR1). 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. Fusion recently entered into an agreement with Hamilton, Ontario-based McMaster University to build a 27,000 square foot current Good Manufacturing Practice (GMP) compliant radiopharmaceutical manufacturing facility designed to support manufacturing of the Company's growing pipeline of TATs.

    About TRIUMF

    TRIUMF is Canada's particle accelerator centre. The lab is a hub for discovery and innovation, inspired by a half-century of ingenuity in answering some of nature's most challenging questions. From the hunt for the smallest particles in the universe to the development of new technologies, TRIUMF is pushing frontiers in research, while training the next generation of leaders in science, medicine, and industry. Learn more about TRIUMF's work to produce actinium-225 here.

    Discover more at www.triumf.ca and connect on Facebook, Twitter, and Instagram: @TRIUMFLab.

    About TRIUMF Innovations

    TRIUMF Innovations Inc. is TRIUMF's business interface and commercialization arm, connecting Canada's particle accelerator centre to the private sector via industry partnerships, licensing, and company creation. TRIUMF Innovations provides pathways for businesses to access the expertise and infrastructure at TRIUMF and across the TRIUMF network.

    Learn more at www.triumfinnovations.ca and connect on Twitter at @TRIUMFInno.

    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 access to actinium-225. 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 or its partners will advance any technology relating to actinium-225 to development , to the regulatory process or to commercialization; management's expectations could be affected by unexpected regulatory actions or delays; uncertainties relating to, or unsuccessful results of, clinical trials and the medical isotopes used therein; 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 March 31, 2021 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.

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/fusion-pharmaceuticals-and-triumf-announce-expanded-rd-collaboration-for-actinium-supply-production-301354567.html

    SOURCE Fusion Pharmaceuticals Inc.

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  4. Phase 1 study of FPI-1434 progressing towards multi-dose data and recommended Phase 2 dose in 1H2022

    FPI-1966 advancing to clinic

    HAMILTON, ON and BOSTON, Aug. 10, 2021 /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 second quarter ended June 30, 2021 and provided an update on clinical and corporate developments.

    "We are building a fully integrated radiopharmaceutical company based upon our platform, reflecting a diverse pipeline of targeted alpha therapies in development supported by manufacturing and supply chain expertise," said Chief Executive Officer John Valliant, Ph.D. "We expect to have three clinical programs employing differentiated radiopharmaceuticals underway by mid-next year. In addition to our ongoing Phase 1 study of FPI-1434, the investigational new drug application (IND) of FPI-1966 was recently cleared by the U.S. Food & Drug Administration (FDA), and we intend to submit an IND application for FPI-2059 in the first half of 2022. In parallel, we are quickly advancing programs under our partnership agreement with AstraZeneca and are planning for a combination study of FPI-1434 with KEYTRUDA® (pembrolizumab)."

    Dr. Valliant continued, "These programs, along with our work to build Fusion's radiopharmaceutical manufacturing capabilities with a new facility, demonstrate the depth and versatility of our pipeline and the potential to use our expertise to create innovative treatments for a broad array of solid tumors with high unmet medical need."

    Recent Highlights and Future Milestones

    Corporate Updates

    • On July 28, Fusion announced the FDA cleared the Company's Investigational New Drug (IND) application for FPI-1966. FPI-1966 is a targeted alpha therapy (TAT) designed to use vofatamab, a human monoclonal antibody, to target and deliver actinium-225 to tumor sites expressing fibroblast growth factor 3 (FGFR3), a protein that is overexpressed in multiple tumor types, particularly head and neck and bladder cancers. Fusion plans to initiate a Phase 1, non-randomized, open-label clinical trial in patients with solid tumors expressing FGFR3 intended to investigate safety, tolerability and pharmacokinetics and to establish the recommended Phase 2 dose. The Company anticipates initiating the Phase 1 study around the end of 2021 and reporting interim data from the first patient cohort around the end of 2022.
    • On June 14, Fusion announced the presentation of preliminary Phase 1 data from the single-dose portion of the study at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Virtual Annual Meeting. Results from the first three patient cohorts (n=12) demonstrated a favorable safety profile for FPI-1434. No drug-related serious adverse events and/or dose limiting toxicity were reported in administered activity up to 40kBq/kg body weight and dosimetric results were within normal organ radiation tolerability limits.
    • On June 14, Fusion also announced preclinical data demonstrating synergistic efficacy against olaparib-resistant colorectal and radioresistant lung cancer xenografts when combining FPI-1434 with olaparib, and preclinical data showing that treatment with FPI-1434 in combination with immune checkpoint inhibitors resulted in complete tumor eradication.
    • On June 2, Fusion announced that the Company entered a 15-year lease agreement with Hamilton, Ontario-based McMaster University to build a 27,000 square foot current Good Manufacturing Practice (GMP) compliant radiopharmaceutical manufacturing facility. The facility, to be built by McMaster and equipped and validated by Fusion, will be designed to support manufacturing of the Company's growing pipeline of targeted alpha therapies (TATs).

    FPI-1434 Monotherapy

    • Fusion continues to advance the multi-dose portion of its Phase 1 study evaluating FPI-1434 in patients with advanced solid tumors. The dose-finding study is enrolling patients at sites in Canada, the United States and Australia.
    • Fusion anticipates reporting Phase 1 multi-dose safety and imaging data, and the recommended Phase 2 dose and schedule, in the first half of 2022.

    FPI-1434 Combination Therapy

    • Fusion has evaluated FPI-1434 in preclinical studies in combination with approved checkpoint and DNA damage response inhibitors, including PARP inhibitors, and believes the synergies observed could expand the addressable patient populations for FPI-1434 and allow for potential use in earlier lines of treatment.
    • Fusion anticipates 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-2059

    • FPI-2059 is a small molecule radioconjugate in development as a targeted alpha therapy for various solid tumors. The molecule targets neurotensin receptor 1 (NTSR1), a promising target for cancer treatment, that is overexpressed in multiple solid tumors. FPI-2059 combines Ipsen's IPN-1087, which Fusion acquired in 2021, with actinium-225. Fusion anticipates submitting an IND application for FPI-2059 in the first half of 2022.

    Second Quarter 2021 Financial Results

    • Cash and Investments: As of June 30, 2021, Fusion held cash, cash equivalents and investments of $260.5 million, compared to cash, cash equivalents and investments of $299.5 million as of December 31, 2020. Fusion expects its cash, cash equivalents and investments as of June 30, 2021 will enable the Company to fund its operations through the end of 2023.
    • Collaboration Revenue: For the second quarter of 2021, Fusion recorded $0.5 million of revenue under the AstraZeneca collaboration agreement.
    • R&D Expenses: Research and development expenses for the second quarter of 2021 were $21.1 million, compared to $3.3 million for the same period in 2020. The increase was primarily related to increased platform development and research activities, clinical activities related to the ongoing Phase 1 clinical trial of FPI-1434, asset purchase agreements and preclinical research and manufacturing costs.
    • G&A Expenses: General and administrative expenses for the second quarter of 2021 were $6.6 million, compared to $4.0 million for the same period in 2020. The increase was primarily related to personnel related costs, including salary, benefits and stock compensation due to hiring, as well as general corporate costs, including expenses for general corporate, director and officer insurance.
    • Net Loss: For the second quarter of 2021, Fusion reported a net loss of $26.9 million, or $0.63 per share, compared with a net loss of $44.7 million, or $18.91 per share, for the same period in 2020. On a non-GAAP basis, excluding a change in fair value of preferred share tranche right liability and warrant liability, net loss was $7.1 million for the second quarter of 2020.

    Impact of COVID-19

    While Fusion is progressing the multi-dosing portion of the Phase 1 clinical trial of FPI-1434, the Company has experienced material delays in patient recruitment and enrollment as a result of continued resourcing issues related to COVID-19 at trial sites.

    Moreover, there remains uncertainty relating to the trajectory of the pandemic and whether it may cause further delays in patient study recruitment. The impact of related responses and disruptions caused by the COVID-19 pandemic may result in difficulties or delays in initiating, enrolling, conducting or completing the planned and ongoing trials and the incurrence of unforeseen costs as a result of disruptions in clinical supply or preclinical study or clinical trial delays. The continued impact of COVID-19 on results will largely depend on future developments, which are highly uncertain and cannot be predicted with confidence.

    About Fusion

    Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Employing a proprietary Fast-Clear™ linker technology, Fusion connects alpha particle emitting isotopes to various targeting molecules in order to selectively deliver the alpha emitting payloads to tumors.

    Fusion's lead program, FPI-1434 targeting insulin-like growth factor 1 receptor, is currently in a Phase 1 clinical trial. The pipeline includes FPI-1966 targeting the fibroblast growth factor receptor 3 (FGFR3) and FPI-2059, a small molecule recently acquired from Ipsen, targeting neurotensin receptor 1 (NTSR1). In addition to a robust proprietary pipeline, Fusion has a collaboration with AstraZeneca to jointly develop up to three novel targeted alpha therapies (TATs) and explore up to five combination programs between Fusion's TATs and AstraZeneca's DNA Damage Repair Inhibitors (DDRis) and immuno-oncology agents. Fusion 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.

    Forward-Looking Statements

    Certain statements set forth in this press release constitute "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements can be identified by terms such as "believes," "expects," "plans," "potential," "would" or similar expressions and the negative of those terms. Such forward-looking statements involve substantial risks and uncertainties that could cause Fusion's research and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including Fusions' programs' early stage of development, the ability to move in-licensed targets forward in the clinic,  the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products generally and radiopharmaceuticals specifically, Fusion's ability to successfully establish, protect and defend its intellectual property, risks relating to business interruptions resulting from the coronavirus (COVID-19) disease outbreak or similar public health crises and other matters that could affect the sufficiency of existing cash to fund operations. Fusion undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the company in general, see Fusion's annual report on Form 10-Q for the quarter ended March 31, 2021 which is available on the Securities and Exchange Commission's website at www.sec.gov and Fusion's website at www.fusionpharma.com

    Investors and others should note that Fusion communicates with its investors and the public using the Fusion website, www.fusionpharma.com, 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.

     

    FUSION PHARMACEUTICALS INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (In thousands, except share amounts)

    (Unaudited)







    June 30,

    2021



    December 31,

    2020

    Assets









    Current assets:









    Cash and cash equivalents



    $                   27,615



    $                   90,517

    Accounts receivable



    121



    Short-term investments



    150,904



    131,882

    Prepaid expenses and other current assets



    5,847



    5,340

    Restricted cash



    669



    425

    Total current assets



    185,156



    228,164

    Property and equipment, net



    2,659



    1,967

    Deferred tax assets



    1,067



    653

    Restricted cash



    1,222



    1,466

    Long-term investments



    81,974



    77,082

    Operating lease right-of-use assets



    7,224



    Other non-current assets



    2,854



    1,344

    Total assets



    $                 282,156



    $                 310,676

    Liabilities and Shareholders' Equity









    Current liabilities:









    Accounts payable



    $                        685



    $                     3,399

    Accrued expenses



    5,682



    4,659

    Income taxes payable





    2,799

    Deferred revenue



    1,733



    1,000

    Operating lease liabilities



    1,265



    Total current liabilities



    9,365



    11,857

    Deferred rent, net of current portion





    11

    Income taxes payable, net of current portion



    295



    295

    Deferred revenue, net of current portion



    2,867



    4,000

    Operating lease liabilities, net of current portion



    6,078



    Total liabilities



    18,605



    16,163

    Commitments and contingencies









    Shareholders' equity:









    Common shares, no par value, unlimited shares authorized as of June 30, 2021

       and December 31, 2020; 42,621,099 and 41,725,797 shares issued and outstanding as of

       June 30, 2021 and December 31, 2020, respectively





    Additional paid-in capital



    420,799



    407,672

    Accumulated other comprehensive income



    337



    44

    Accumulated deficit



    (157,585)



    (113,203)

    Total shareholders' equity



    263,551



    294,513

    Total liabilities and shareholders' equity



    $                 282,156



    $                 310,676

     

    FUSION PHARMACEUTICALS INC.

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

    (In thousands, except share and per share amounts)

    (Unaudited)







    Three Months Ended

    June 30,



    Six Months Ended

    June 30,





    2021



    2020



    2021



    2020

    Collaboration revenue



    $               521



    $                 —



    $               521



    $                 —

    Operating expenses:

















    Research and development



    21,146



    3,325



    31,862



    7,702

    General and administrative



    6,642



    3,988



    13,606



    8,315

    Total operating expenses



    27,788



    7,313



    45,468



    16,017

    Loss from operations



    (27,267)



    (7,313)



    (44,947)



    (16,017)

    Other income (expense):

















    Change in fair value of preferred share tranche right liability





    (31,604)





    (32,722)

    Change in fair value of preferred share warrant liability





    (6,065)





    (6,399)

    Interest income (expense), net



    97



    22



    193



    169

    Refundable investment tax credits





    52





    98

    Other income (expense), net



    331



    325



    379



    128

    Total other income (expense), net



    428



    (37,270)



    572



    (38,726)

    Loss before provision for income taxes



    (26,839)



    (44,583)



    (44,375)



    (54,743)

    Income tax provision



    (14)



    (150)



    (7)



    (212)

    Net loss



    (26,853)



    (44,733)



    (44,382)



    (54,955)

    Unrealized gain on investments



    54





    293



    Comprehensive loss



    (26,799)



    (44,733)



    (44,089)



    (54,955)

    Reconciliation of net loss to net loss attributable to common shareholders:

















    Net loss



    (26,853)



    (44,733)



    (44,382)



    (54,955)

    Dividends paid to preferred shareholders in the form of

       warrants issued









    (1,382)

    Net loss attributable to common shareholders



    $        (26,853)



    $        (44,733)



    $        (44,382)



    $        (56,337)

    Net loss per share attributable to common shareholders—basic and

       diluted



    $            (0.63)



    $          (18.91)



    $            (1.05)



    $          (26.23)

    Weighted-average common shares outstanding—basic and diluted



    42,501,321



    2,366,198



    42,145,435



    2,147,876

     

     

    FUSION PHARMACEUTICALS INC.

    CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

    (In thousands)

    (Unaudited)







    Six Months Ended June 30,





    2021



    2020

    Cash flows from operating activities:









    Net loss



    $                (44,382)



    $                (54,955)

    Adjustments to reconcile net loss to net cash used in operating activities:









    Share-based compensation expense



    3,863



    784

    Depreciation and amortization expense



    265



    270

    Non-cash lease expense



    516



    14

    Change in fair value of preferred share tranche right liability





    32,722

    Change in fair value of preferred share warrant liability





    6,399

    Amortization of premiums (accretion of discounts) on investments, net



    924



    Deferred tax benefit



    (413)



    Common shares issued to acquire in-process research & development



    8,924



    Foreign exchange loss



    36



    Changes in operating assets and liabilities:









    Accounts receivable



    (121)



    Prepaid expenses and other current assets



    (374)



    (103)

    Other non-current assets



    (1,509)



    Accounts payable



    (2,687)



    (319)

    Accrued expenses



    673



    1,209

    Deferred revenue



    (400)



    Income taxes payable



    (2,800)



    162

    Operating lease liabilities



    (418)



    Net cash used in operating activities



    (37,903)



    (13,817)

    Cash flows from investing activities:









    Purchases of investments



    (132,137)



    Maturities of investments



    107,591



    Purchases of property and equipment



    (793)



    (382)

    Net cash used in investing activities



    (25,339)



    (382)

    Cash flows from financing activities:









    Proceeds from issuance of Class B convertible preferred shares and Class B preferred

       share tranche right, net of issuance costs





    65,676

    Proceeds from issuance of Class B preferred exchangeable shares of Fusion

       Pharmaceuticals (Ireland) Limited and Class B preferred share tranche right,

       net of issuance costs





    6,722

    Proceeds from the issuance of common shares upon closing of initial public offering,

         net of underwriter fees





    197,625

    Payment of offering costs





    (2,276)

    Proceeds from issuance of common shares upon exercise of stock options



    340



    Net cash provided by financing activities



    340



    267,747

    Net (decrease) increase in cash, cash equivalents and restricted cash



    (62,902)



    253,548

    Cash, cash equivalents and restricted cash at beginning of period



    92,408



    67,121

    Cash, cash equivalents and restricted cash at end of period



    $                  29,506



    $                320,669

    Supplemental disclosure of cash flow information:









    Cash paid for income taxes



    $                    3,494



    $                         50

    Right-of-use assets obtained in exchange for new operating lease liabilities



    $                    1,166



    $                         —

    Increase in right-of-use assets and operating lease liabilities from operating lease

       modifications



    $                       911



    $                         —

    Supplemental disclosure of non-cash investing and financing activities:









    Purchases of property and equipment included in accounts payable and accrued expenses



    $                       199



    $                         —

    Issuance of warrants to purchase Class B preferred shares and Class B preferred

       exchangeable shares as a non-cash dividend to preferred shareholders



    $                         —



    $                    1,382

    Deferred offering costs included in accounts payable and accrued expenses



    $                       160



    $                    2,296

     

     

    FUSION PHARMACEUTICALS INC.

    RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL RESULTS

    (In thousands)

    (Unaudited)























    Three Months Ended

    June 30,



    Six Months Ended

    June 30,





    2021



    2020



    2021



    2020

    GAAP Net loss



    $            (26,853)



    $           (44,733)



    $           (44,382)



    $           (54,955)

    Less: Adjustments

















    Change in fair value of preferred share tranche right liability





    (31,604)





    (32,722)

    Change in fair value of preferred share warrant liability





    (6,065)





    (6,399)

    Non-GAAP Net loss



    $            (26,853)



    $             (7,064)



    $           (44,382)



    $           (15,834)



















     

     

     

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  5. HAMILTON, ON and BOSTON, Aug. 5, 2021 /PRNewswire/ -- Fusion Pharmaceuticals Inc. (NASDAQ:FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced that the Company will participate in the "Hot Topic - Radiopharmaceuticals" panel discussion at the 2021 Wedbush PacGrow Healthcare Virtual Conference on Wednesday, August 11, 2021 at 4:05pm EDT. Participating in the panel on behalf of Fusion will be Chief Executive Officer John Valliant, Ph.D.

    About Fusion

    Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Employing a proprietary Fast-Clear™ linker technology, Fusion connects alpha particle emitting isotopes to various targeting molecules in order to selectively deliver the alpha emitting payloads to tumors. Fusion's lead program, FPI-1434 targeting insulin-like growth factor 1 receptor, is currently in a Phase 1 clinical trial. The pipeline includes FPI-1966 targeting the fibroblast growth factor receptor 3 (FGFR3) and FPI-2059, a small molecule acquired from Ipsen, targeting neurotensin receptor 1 (NTSR1). In addition to a robust proprietary pipeline, Fusion has a collaboration with AstraZeneca to jointly develop up to three novel targeted alpha therapies (TATs) and explore up to five combination programs between Fusion's TATs and AstraZeneca's DNA Damage Repair Inhibitors (DDRis) and immuno-oncology agents. Fusion 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.

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  6. HAMILTON, ON and BOSTON, July 28, 2021 /PRNewswire/ -- Fusion Pharmaceuticals Inc. (NASDAQ:FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) applications for [225Ac]-FPI-1966 (FPI-1966) and imaging agent [111In]-FPI-1967 (FPI-1967). FPI-1966 is a targeted alpha therapy (TAT) designed to use vofatamab, a human monoclonal antibody, to target and deliver actinium-225 to tumor sites expressing fibroblast growth factor 3 (FGFR3), a protein that is overexpressed in multiple tumor types, particularly head and neck and bladder cancers. FPI-1966 utilizes Fusion's…

    HAMILTON, ON and BOSTON, July 28, 2021 /PRNewswire/ -- Fusion Pharmaceuticals Inc. (NASDAQ:FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) applications for [225Ac]-FPI-1966 (FPI-1966) and imaging agent [111In]-FPI-1967 (FPI-1967). FPI-1966 is a targeted alpha therapy (TAT) designed to use vofatamab, a human monoclonal antibody, to target and deliver actinium-225 to tumor sites expressing fibroblast growth factor 3 (FGFR3), a protein that is overexpressed in multiple tumor types, particularly head and neck and bladder cancers. FPI-1966 utilizes Fusion's Fast-Clear™ linker to connect vofatamab to actinium-225.

    "Leveraging Fusion's platform and expertise developing targeted alpha therapies, we are excited to begin our second clinical program," said Chief Executive Officer John Valliant, Ph.D. "FGFR3 is an established and validated cancer target which is found in multiple tumor types with substantial unmet need, notably head and neck and bladder cancers. We have an opportunity to selectively deliver alpha particles to these tumors and use precision radiation therapy as a new treatment paradigm. While the currently approved pan-FGFR inhibitor for bladder cancer requires the presence of a specific mutation, our approach requires only over-expression of FGFR3. If successful, this could provide an opportunity to treat a larger population of patients."

    Fusion plans to initiate a Phase 1, non-randomized, open-label clinical trial in patients with solid tumors expressing FGFR3 intended to investigate safety, tolerability and pharmacokinetics and to establish the recommended Phase 2 dose. The study employs a 3 + 3 dose escalation design to evaluate multiple ascending doses of FPI-1966. The first cohort will comprise four 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. As part of the screening process, patients will be administered an imaging analogue of FPI-1966, FPI-1967, and only those who meet predefined tumor uptake and safety criteria will go on to receive FPI-1966.

    About FPI-1966

    [225Ac]-FPI-1966 is a targeted alpha therapy designed to target and deliver an alpha emitting medical isotope, actinium-225, to cancer cells expressing FGFR3; a receptor that is overexpressed on several tumor types, including head and neck and bladder cancers. FPI-1966 utilizes Fusion's Fast-Clear™ linker to connect vofatamab, the human monoclonal antibody that targets FGFR3, with actinium-225. Vofatamab was previously evaluated as a therapeutic agent in a Phase 1b/2 trial and was reportedly well-tolerated.

    About Fusion

    Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Employing a proprietary Fast-Clear™ linker technology, Fusion connects alpha particle emitting isotopes to various targeting molecules in order to selectively deliver the alpha emitting payloads to tumors. Fusion's lead program, FPI-1434 targeting insulin-like growth factor 1 receptor, is currently in a Phase 1 clinical trial. The pipeline includes FPI-1966 targeting the fibroblast growth factor receptor 3 (FGFR3) and FPI-2059, a small molecule recently acquired from Ipsen, targeting neurotensin receptor 1 (NTSR1). In addition to a robust proprietary pipeline, Fusion has a collaboration with AstraZeneca to jointly develop up to three novel targeted alpha therapies (TATs) and explore up to five combination programs between Fusion's TATs and AstraZeneca's DNA Damage Repair Inhibitors (DDRis) and immuno-oncology agents. Fusion also recently 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.

    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 product candidate FPI-1966. 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 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 March 31, 2021 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, www.fusionpharma.com, 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.

     

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  7. HAMILTON, Ontario and BOSTON, July 7, 2021 /PRNewswire/ -- Fusion Pharmaceuticals Inc. (NASDAQ:FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced that the compensation committee of the Company's Board of Directors granted stock option awards to purchase an aggregate of 90,400 shares of its common stock to one employee outside Fusion's 2020 Stock Option and Incentive Plan. The stock options were granted as an inducement material to the individual becoming an employee of Fusion in accordance with Nasdaq Listing Rule 5635(c)(4).

    The options have an exercise price of $8.23 per share, which is equal to the closing price of Fusion's common stock on July 6, 2021. Each option has a ten-year term and vests over four years, with 25% of the original number of shares vesting on the one-year anniversary of the grant date and then in equal installments for 36 months thereafter, subject to the employee's continued service with Fusion through the applicable vesting dates.

    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 targeting molecules in order to selectively deliver the alpha emitting payloads to tumors. Fusion's lead program, FPI-1434, is currently in a Phase 1 clinical trial. The Company is advancing a pipeline of targeted radiopharmaceutical cancer therapies for a broad array of tumor types based upon its proprietary platform which includes internal research and development capabilities, manufacturing and supply chain expertise, and the Company's proprietary Fast-Clear™ linker technology.

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  8. Product candidate FPI-1434, administered at three different dose levels, demonstrated a favorable safety profile with no drug-related serious adverse events or dose-limiting toxicity

    Imaging shows drug uptake across multiple tumor types

    Enrollment in multi-dosing cohorts continues

    Fusion also reported preclinical data showing the combination of FPI-1434 with olaparib resulting in synergistic efficacy against colorectal and lung cancer xenografts, and combination with immune checkpoint inhibitors demonstrated enhanced efficacy in colorectal cancer models

    Data featured in oral sessions and posters at the SNMMI 2021 Virtual Annual Meeting

    HAMILTON, Ontario and BOSTON, June 14, 2021 /PRNewswire/ -- Fusion Pharmaceuticals Inc. (NASDAQ:FUSN

    Product candidate FPI-1434, administered at three different dose levels, demonstrated a favorable safety profile with no drug-related serious adverse events or dose-limiting toxicity

    Imaging shows drug uptake across multiple tumor types

    Enrollment in multi-dosing cohorts continues

    Fusion also reported preclinical data showing the combination of FPI-1434 with olaparib resulting in synergistic efficacy against colorectal and lung cancer xenografts, and combination with immune checkpoint inhibitors demonstrated enhanced efficacy in colorectal cancer models

    Data featured in oral sessions and posters at the SNMMI 2021 Virtual Annual Meeting

    HAMILTON, Ontario and BOSTON, June 14, 2021 /PRNewswire/ -- Fusion Pharmaceuticals Inc. (NASDAQ:FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced the presentation of preliminary Phase 1 data from the single-dose portion of the study at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Virtual Annual Meeting. The presentations and posters highlight the potential of Fusion's targeted alpha therapies (TATs) to enable delivery of alpha particle emitting isotopes (225Ac) to targeted tumor cells.

    "The data from our ongoing clinical study of FPI-1434 presented at SNMMI demonstrated that treatment with our actinium-based targeted alpha therapy was well tolerated, and imaging shows uptake of the drug across multiple tumor types," said Chief Executive Officer John Valliant, Ph.D. "Importantly, these data supported our ability to initiate the multi-dosing portion of the study, in which we would expect to begin reaching total cumulative levels of radiation necessary to demonstrate anti-tumor activity."

    In both the oral session and the poster titled, "Preliminary Dosimetry Results from a First-in-Human Phase 1 Study Evaluating the Efficacy and Safety of [225Ac]-FPI-1434 in Patients with IGF-1R Expressing Solid Tumors," results from the first three patient cohorts (n=12) demonstrated a favorable safety profile for [225Ac]-FPI-1434. No drug-related serious adverse events and/or dose limiting toxicity were reported in administered activity up to 40 kBq/kg body weight and dosimetric results were within normal organ radiation tolerability limits. The single dose escalation portion of the study has concluded, while enrollment into the multi-dosing cohorts are ongoing.

    Preclinical Results Combining FPI-1434 with DNA Damage Response Inhibitor (DDRi) and Immune Checkpoint Inhibitors

    In separate oral and poster presentations, Fusion presented preclinical data demonstrating synergistic efficacy against olaparib-resistant colorectal and radioresistant lung cancer xenografts when combining FPI-1434 with olaparib.

    The combination of the two therapeutics, using doses that were non-effective as single agents, resulted in anti-tumor efficacy against colorectal and non-small cell lung cancer tumor models. The strongest combination effect appeared to occur at the lowest single agent doses, as FPI-1434's efficacy dominated at higher dose levels.

    Fusion also presented preclinical data showing that treatment with FPI-1434 in combination with immune checkpoint inhibitors resulted in complete tumor eradication. Additionally, an increase in antigen-specific CD8 positive T cells and a strong "vaccine" effect were observed with the combination of IGF-1R TAT and immune checkpoint inhibitors, as noted by the prevention of tumor growth in animals that were reinoculated with the same tumor cells.

    Dr. Valliant continued, "We are excited by our preclinical data that show the power of combining a potent TAT with the latest generation of cancer therapies, such as checkpoint inhibitors and DDRis. We view these combinations as an opportunity to bring these next-generation radiopharmaceuticals into earlier lines of therapy for patients, and we look forward to initiating combination studies in human once we have achieved the recommended Phase 2 dose for FPI-1434 monotherapy. Our previously announced collaborations with both Merck and AstraZeneca provide us with multiple opportunities to explore these exciting combination therapies."

    Following the conclusion of the SNMMI Annual Meeting, copies of the presentations can be found at https://fusionpharma.com/fusion-scientific-presentations/.

    About FPI-1434

    FPI-1434 is a radioimmunoconjugate designed to target and deliver alpha emitting medical isotopes to cancer cells expressing IGF-1R, a receptor that is overexpressed on many tumor types. FPI-1434 utilizes Fusion's Fast-Clear linker to connect a human monoclonal antibody that targets IGF-1R with actinium-225, a powerful alpha-emitting isotope with desirable half-life and decay chain properties.

    About Fusion

    Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Employing a proprietary Fast-Clear™ linker technology, Fusion connects alpha particle emitting isotopes to various targeting molecules in order to selectively deliver the alpha emitting payloads to tumors.

    Fusion's lead program, FPI-1434 targeting insulin-like growth factor 1 receptor, is currently in a Phase 1 clinical trial. The pipeline includes FPI-1966 targeting the fibroblast growth factor receptor 3 (FGFR3) and FPI-2059, a small molecule recently acquired from Ipsen, targeting neurotensin receptor 1 (NTSR1). In addition to a robust proprietary pipeline, Fusion has a collaboration with AstraZeneca to jointly develop up to three novel targeted alpha therapies (TATs) and explore up to five combination programs between Fusion's TATs and AstraZeneca's DNA Damage Repair Inhibitors (DDRis) and immuno-oncology agents. Fusion also recently 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.

    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 product candidate FPI-1434; and the likelihood of success of any ongoing or future clinical trials involving product candidate FPI-1434. 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 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-K for the quarter ended December 31, 2020 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.

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  9. HAMILTON, ON and BOSTON, June 7, 2021 /PRNewswire/ -- Fusion Pharmaceuticals Inc. (NASDAQ:FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced the appointment of Isabelle Dussault, Ph.D. as senior vice president, research.

    "Isabelle brings deep oncology research experience, including antibody-drug conjugate, biomarker and immuno-oncology expertise, to our team and we are pleased to welcome her," said Chief Executive Officer John Valliant, Ph.D. "Fusion's research capabilities are a core pillar of our platform. We look forward to Isabelle's contributions to expanding our pipeline of radiopharmaceuticals in early development and continuing to grow and leverage our leadership in understanding the biology of targeted alpha therapies."

    Dr. Dussault was most recently global head of clinical biomarker strategy at EMD Serono, a subsidiary of Merck KGaA, where she oversaw clinical biomarker strategy for the entire portfolio. Prior to that, she was director of oncology research, tumor micro-environment and immuno-oncology at Bristol-Myers Squibb following her role as a director of oncology research for Merck and Amgen. Dr. Dussault holds Ph.D. and B.Sc. degrees from McGill University.

    Inducement Equity Awards

    Fusion's Compensation Committee of the Board of Directors approved a grant of stock options to Dr. Dussault to purchase 132,000 of Fusion's common shares. Each option was granted as an inducement equity award outside Fusion's 2020 Stock Option and Incentive Plan and was made as an inducement material to Dr. Dussault's acceptance of employment with Fusion. Each option grant has an exercise price equal to the closing price of Fusion's common shares on June 8, 2021. Each option has a ten-year term and vests over four years, with 25% of the original number of shares vesting on the one-year anniversary of the grant date and monthly thereafter, subject to Dr. Dussault's continued service with Fusion through the applicable vesting dates.

    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 targeting molecules in order to selectively deliver the alpha emitting payloads to tumors. Fusion's lead program, FPI-1434, is currently in a Phase 1 clinical trial. The Company is advancing a pipeline of targeted radiopharmaceutical cancer therapies for a broad array of tumor types based upon its proprietary platform which includes internal research and development capabilities, manufacturing and supply chain expertise, and the Company's proprietary Fast-Clear™ linker technology.

     

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  10. HAMILTON, ON and BOSTON, June 2, 2021 /PRNewswire/ -- Fusion Pharmaceuticals Inc. (NASDAQ:FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced it entered a 15-year lease agreement with Hamilton, Ontario-based McMaster University to build a 27,000 square foot current Good Manufacturing Practice (GMP) compliant radiopharmaceutical manufacturing facility. The facility, to be built by McMaster and equipped and validated by Fusion, will be designed to support manufacturing of the Company's growing pipeline of targeted alpha therapies (TATs). Fusion expects the manufacturing facility will be operational by early 2024.

    HAMILTON, ON and BOSTON, June 2, 2021 /PRNewswire/ -- Fusion Pharmaceuticals Inc. (NASDAQ:FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced it entered a 15-year lease agreement with Hamilton, Ontario-based McMaster University to build a 27,000 square foot current Good Manufacturing Practice (GMP) compliant radiopharmaceutical manufacturing facility. The facility, to be built by McMaster and equipped and validated by Fusion, will be designed to support manufacturing of the Company's growing pipeline of targeted alpha therapies (TATs). Fusion expects the manufacturing facility will be operational by early 2024.

    "Manufacturing and supply chain are critical components of radiopharmaceutical development and commercialization, and with Fusion's expertise, we believe we are well-positioned to create a facility to scale production in support of our growing pipeline and development collaborations," said Fusion Chief Executive Officer John Valliant, Ph.D. "We will continue to prioritize manufacturing and supply chain infrastructure in our long-term plans, and this facility is an important milestone in executing those plans.The location of the facility, adjacent to our internal research organization and a world-class University that specializes in medical isotope research and training, enables us to efficiently advance new TATs and hire top tier talent to support our leading portfolio of radiopharmaceuticals."  

    In conjunction with the execution of the lease agreement, Fusion has entered into a services agreement with its long-time partner, the Centre for Probe Development and Commercialization (CPDC), to provide services relating to certain aspects of the validation of this new manufacturing facility.

    About Fusion

    Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Employing a proprietary Fast-Clear™ linker technology, Fusion connects alpha particle emitting isotopes to various targeting molecules in order to selectively deliver the alpha emitting payloads to tumors.

    Fusion's lead program, FPI-1434 targeting insulin-like growth factor 1 receptor, is currently in a Phase 1 clinical trial. The pipeline includes FPI-1966 targeting the fibroblast growth factor receptor 3 (FGFR3) and FPI-2059, a small molecule recently acquired from Ipsen, targeting neurotensin receptor 1 (NTSR1). In addition to a robust proprietary pipeline, Fusion has a collaboration with AstraZeneca to jointly develop up to three novel targeted alpha therapies (TATs) and explore up to five combination programs between Fusion's TATs and AstraZeneca's DNA Damage Repair Inhibitors (DDRis) and immuno-oncology agents. Fusion also recently 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.

    Forward-Looking Statements

    Certain statements set forth in this press release constitute "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements can be identified by terms such as "believes," "expects," "plans," "potential," "would" or similar expressions and the negative of those terms. Such forward-looking statements involve substantial risks and uncertainties that could cause Fusion's research and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the development, build-out and operations of a manufacturing facility, risks relating to business interruptions resulting from the coronavirus (COVID-19) disease outbreak or similar public health crises and other matters that could affect the sufficiency of existing cash to fund operations. Fusion undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the company in general, see Fusion's quarterly report on Form 10-Q for the period ended March 31, 2021 which is available on the Securities and Exchange Commission's website at www.sec.gov and Fusion's website at www.fusionpharma.com.  

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  11. HAMILTON, ON and BOSTON, May 27, 2021 /PRNewswire/ -- Fusion Pharmaceuticals Inc. (NASDAQ:FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced that the Company will present at the Jefferies Virtual Healthcare Conference on Thursday, June 3, 2021 at 11:00am EDT. Presenting on behalf of Fusion will be Chief Executive Officer John Valliant, Ph.D.

    A live webcast of the event will be available on the "Events and Presentations" page in the "Investors & Media" section of the Company's website at https://ir.fusionpharma.com/events-webcasts. A replay of the webcast will be archived on the Company's website for 30 days following the presentation.  

    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 targeting molecules in order to selectively deliver the alpha emitting payloads to tumors. Fusion's lead program, FPI-1434, is currently in a Phase 1 clinical trial. The Company is advancing a pipeline of targeted radiopharmaceutical cancer therapies for a broad array of tumor types based upon its proprietary platform which includes internal research and development capabilities, manufacturing and supply chain expertise, and the Company's proprietary Fast-Clear™ linker technology.

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  12. Phase 1 study of FPI-1434 Phase 1 enrollment continues on track for data in 1H2022

    Continuing expansion of pipeline of targeted alpha therapies through recently completed transactions

    HAMILTON, ON and BOSTON, May 11, 2021 /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 first quarter ended March 31, 2021 and provided an update on clinical and corporate developments.

    "We continue to advance our Phase 1 study of FPI-1434," said Chief Executive Officer John Valliant, Ph.D. "In anticipation of data and determination of a recommended Phase 2 dose in the first half of 2022, we are amending the study protocol to define tumor-specific cohorts based upon IGF-1R expression and tumor uptake as seen to date in the Phase 1 study."

    Dr. Valliant continued, "In parallel, we are building a diverse pipeline of alpha-emitting radiopharmaceuticals. We expect to file our investigational new drug (IND) application for FPI-1966 in the second quarter of this year. In addition, we recently completed the acquisition of IPN-1087, a first-in-class small molecule beta-emitting radiopharmaceutical targeting neurotensin receptor 1 (NTSR1), which is expressed on multiple solid tumors and which we plan to convert into alpha-emitting FPI-2059. These programs demonstrate the depth and versatility of Fusion's radiopharmaceutical platform and our potential to treat a broad array of solid tumors with high unmet medical need.

    "Evidenced by our recent presentations at the American Association for Cancer Research (AACR) Annual Meeting, we are excited about the potential to evaluate Fusion's TATs in combination with the latest generation of cancer therapies, including checkpoint inhibitors and DNA damage response inhibitors (DDRis). Our recently announced collaborations with Merck and AstraZeneca enable us to explore these combination therapies and highlight the growing interest in TAT therapies."

    Recent Highlights and Future Milestones

    Corporate Updates

    • On May 6, Fusion announced that it has entered a clinical trial collaboration with a subsidiary of Merck to evaluate FPI-1434 in combination with Merck's anti-PD-1 (programmed death receptor-1) therapy, KEYTRUDA® (pembrolizumab), in patients with solid tumors expressing insulin-like growth factor 1 receptor (IGF-1R). The planned Phase 1 combination trial will evaluate safety, tolerability and pharmacokinetics of the combination and is expected to initiate approximately six to nine months after achieving the recommended Phase 2 dose in the ongoing Phase 1 study of FPI-1434 monotherapy. Under the terms of the agreement, Fusion will sponsor the study and Merck will supply KEYTRUDA.
    • On April 10, Fusion announced the presentation of preclinical data at the 2021 AACR Virtual Annual Meeting. The posters, titled "Combination of IGF-1R Targeted Alpha Therapy with Olaparib Results in Synergistic Efficacy Against Colorectal and Lung Cancer Xenografts" and "Combination of IGF-1R Targeted Alpha Therapy with Checkpoint Inhibitors Results in Synergistic Efficacy in Colorectal Cancer Syngeneic Model," highlight the potential of Fusion's targeted alpha therapies (TATs) as both monotherapies and combination therapies.
    • On April 1, Fusion announced the closing of its acquisition of Ipsen's assets and intellectual property related to IPN-1087. IPN-1087, previously studied in a Phase 1 trial, is a small molecule targeting NTSR1, a protein expressed on multiple solid tumor types. Fusion is using IPN-1087 to create a first-in-class alpha-emitting radiopharmaceutical, FPI-2059, targeting solid tumors expressing NTSR1. The Company expects to submit an IND application in the first half of 2022.

    FPI-1434 Monotherapy

    • Fusion continues to advance the multi-dose portion of its Phase 1 study evaluating FPI-1434 in patients with advanced solid tumors. The dose-finding study is enrolling patients at sites in Canada, the United States and Australia.
    • Fusion anticipates reporting Phase 1 multi-dose safety and imaging data, and the recommended Phase 2 dose and schedule, in the first half of 2022.

    FPI-1434 Combination Therapy

    • Fusion has evaluated FPI-1434 in preclinical studies in combination with approved checkpoint and DNA damage response inhibitors, including PARP inhibitors, and believes the synergies observed could expand the addressable patient populations for FPI-1434 and allow for potential use in earlier lines of treatment.
    • As noted above, Fusion anticipates 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

    • FPI-1966 is designed to target and deliver actinium-225 to tumors expressing FGFR3, a protein that is overexpressed in head and neck and bladder cancers. Following the completion of pre-clinical studies, the Company expects to submit an IND for FPI-1966 in the second quarter of 2021.

    First Quarter 2021 Financial Results

    • Cash and Investments: As of March 31, 2021, Fusion held cash, cash equivalents and investments of $278.2 million, compared to cash of $299.5 million as of December 31, 2020. Fusion expects its cash, cash equivalents and investments as of March 31, 2021 will enable the Company to fund its operations through the end of 2023.
    • R&D Expenses: Research and development expenses for the first quarter of 2021 were $10.7 million, compared to $4.4 million for the same period in 2020. The increase was primarily related to increased platform development and research activities, clinical activities related to the ongoing Phase 1 clinical trial of FPI-1434, and preclinical research and manufacturing costs.
    • G&A Expenses: General and administrative expenses for the first quarter of 2021 were $7.0 million, compared to $4.3 million for the same period in 2020. The increase was primarily related to general corporate expenses, including increased professional and consulting fees as a result of public company activities, as well as increased salaries, benefits and stock compensation costs due to hiring.
    • Net Loss: For the first quarter of 2021, Fusion reported a net loss of $17.5 million, or $0.42 per share, compared with a net loss attributable to common shareholders of $11.6 million, or $6.01 per share, for the same period in 2020. On a non-GAAP basis, excluding a change in fair value of preferred share tranche right liability and warrant liability, net loss was $8.8 million for the first quarter of 2020.

    Impact of COVID-19

    While Fusion continues to progress the multi-dosing portion of the Phase 1 clinical trial of FPI-1434, the Company has experienced moderate delays in patient recruitment and enrollment as a result of COVID-19.

    Fusion is closely monitoring how the spread of COVID-19 is affecting the Company's employees, business, preclinical studies and clinical trials. In response to the COVID-19 pandemic, certain employees have transitioned to working remotely and travel has been restricted. Fusion's research labs are operating but with reduced capacity.

    At this time, there is significant uncertainty relating to the trajectory of the pandemic and whether it may cause further delays in patient study recruitment. The impact of related responses and disruptions caused by the COVID-19 pandemic may result in difficulties or delays in initiating, enrolling, conducting or completing the planned and ongoing trials and the incurrence of unforeseen costs as a result of disruptions in clinical supply or preclinical study or clinical trial delays. The impact of COVID-19 on results will largely depend on future developments, which are highly uncertain and cannot be predicted with confidence.

    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 in order to selectively deliver the alpha emitting payloads to tumors. Fusion's lead program, FPI-1434, is currently in a Phase 1 clinical trial. The Company is advancing a pipeline of targeted radiopharmaceutical cancer therapies for a broad array of tumor types based upon its proprietary platform technology.

    Forward-Looking Statements

    Certain statements set forth in this press release constitute "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements can be identified by terms such as "believes," "expects," "plans," "potential," "would" or similar expressions and the negative of those terms. Such forward-looking statements involve substantial risks and uncertainties that could cause Fusion's research and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including Fusions' programs' early stage of development, the ability to move in-licensed targets forward in the clinic,  the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, Fusion's ability to successfully establish, protect and defend its intellectual property, risks relating to business interruptions resulting from the coronavirus (COVID-19) disease outbreak or similar public health crises and other matters that could affect the sufficiency of existing cash to fund operations. Fusion undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the company in general, see Fusion's annual report on Form 10-K for the year ended December 31, 2020 which is available on the Securities and Exchange Commission's website at www.sec.gov and Fusion's website at www.fusionpharma.com.   

     

    FUSION PHARMACEUTICALS INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (In thousands, except share amounts)

    (Unaudited)







    March 31,

    2021



    December 31,

    2020

    Assets









    Current assets:









    Cash and cash equivalents



    $                   41,070



    $                   90,517

    Short-term investments



    186,150



    131,882

    Prepaid expenses and other current assets



    5,966



    5,340

    Restricted cash



    669



    425

    Total current assets



    233,855



    228,164

    Property and equipment, net



    2,559



    1,967

    Deferred tax assets



    653



    653

    Restricted cash



    1,222



    1,466

    Long-term investments



    50,997



    77,082

    Operating lease right-of-use assets



    7,501



    Other non-current assets



    521



    1,344

    Total assets



    $                 297,308



    $                 310,676

    Liabilities and Shareholders' Equity









    Current liabilities:









    Accounts payable



    $                     1,018



    $                     3,399

    Accrued expenses



    4,190



    4,659

    Income taxes payable



    216



    2,799

    Deferred revenue



    1,000



    1,000

    Operating lease liabilities



    1,194



    Total current liabilities



    7,618



    11,857

    Deferred rent, net of current portion





    11

    Income taxes payable, net of current portion



    295



    295

    Deferred revenue, net of current portion



    4,000



    4,000

    Operating lease liabilities, net of current portion



    6,324



    Total liabilities



    18,237



    16,163

    Commitments and contingencies









    Shareholders' equity:









    Common shares, no par value, unlimited shares authorized as of March 31, 2021

       and December 31, 2020; 41,845,181 and 41,725,797 shares issued and outstanding as of

       March 31, 2021 and December 31, 2020, respectively





    Additional paid-in capital



    409,520



    407,672

    Accumulated other comprehensive income



    283



    44

    Accumulated deficit



    (130,732)



    (113,203)

    Total shareholders' equity



    279,071



    294,513

    Total liabilities and shareholders' equity



    $                 297,308



    $                 310,676

     

    FUSION PHARMACEUTICALS INC.

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

    (In thousands, except share and per share amounts)

    (Unaudited)







    Three Months Ended

    March 31,





    2021



    2020

    Operating expenses:









    Research and development



    $                  10,716



    $                    4,377

    General and administrative



    6,964



    4,327

    Total operating expenses



    17,680



    8,704

    Loss from operations



    (17,680)



    (8,704)

    Other income (expense):









    Change in fair value of preferred share tranche right liability





    (1,118)

    Change in fair value of preferred share warrant liability





    (334)

    Interest income (expense), net



    96



    147

    Refundable investment tax credits





    46

    Other income (expense), net



    48



    (197)

    Total other income (expense), net



    144



    (1,456)

    Loss before (provision) benefit for income taxes



    (17,536)



    (10,160)

    Income tax (provision) benefit



    7



    (62)

    Net loss



    (17,529)



    (10,222)

    Unrealized gain on investments



    239



    Comprehensive loss



    (17,290)



    (10,222)

    Reconciliation of net loss to net loss attributable to common shareholders:









    Net loss



    (17,529)



    (10,222)

    Dividends paid to preferred shareholders in the form of

       warrants issued





    (1,382)

    Net loss attributable to common shareholders



    $                (17,529)



    $                (11,604)

    Net loss per share attributable to common shareholders—basic and

       diluted



    $                    (0.42)



    $                    (6.01)

    Weighted-average common shares outstanding—basic and diluted



    41,784,269



    1,929,555

     

    FUSION PHARMACEUTICALS INC.

    CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

    (In thousands)

    (Unaudited)







    Three Months Ended March 31,





    2021



    2020

    Cash flows from operating activities:









    Net loss



    $                (17,529)



    $                (10,222)

    Adjustments to reconcile net loss to net cash used in operating activities:









    Share-based compensation expense



    1,718



    358

    Depreciation and amortization expense



    111



    172

    Non-cash lease expense



    241



    6

    Change in fair value of preferred share tranche right liability





    1,118

    Change in fair value of preferred share warrant liability





    334

    Amortization of premiums (accretion of discounts) on investments, net



    453



    Foreign exchange gain



    (4)



    Changes in operating assets and liabilities:









    Prepaid expenses and other current assets



    (652)



    (186)

    Other non-current assets



    823



    Accounts payable



    (2,346)



    858

    Accrued expenses



    (622)



    (120)

    Income taxes payable



    (2,583)



    62

    Operating lease liabilities



    (206)



    Net cash used in operating activities



    (20,596)



    (7,620)

    Cash flows from investing activities:









    Purchases of investments



    (66,074)



    Maturities of investments



    37,660



    Purchases of property and equipment



    (584)



    (214)

    Net cash used in investing activities



    (28,998)



    (214)

    Cash flows from financing activities:









    Proceeds from issuance of Class B convertible preferred shares and Class B preferred

       share tranche right, net of issuance costs





    9,907

    Proceeds from issuance of common shares upon exercise of stock options



    130



    Net cash provided by financing activities



    130



    9,907

    Effect of exchange rate fluctuations on cash and cash equivalents held



    17



    Net (decrease) increase in cash, cash equivalents and restricted cash



    (49,447)



    2,073

    Cash, cash equivalents and restricted cash at beginning of period



    92,408



    67,121

    Cash, cash equivalents and restricted cash at end of period



    $                  42,961



    $                  69,194

    Supplemental disclosure of cash flow information:









    Cash paid for income taxes



    $                    2,559



    $                         —

    Right-of-use assets obtained in exchange for new operating lease liability



    $                    2,077



    $                         —

    Supplemental disclosure of non-cash investing and financing activities:









    Purchases of property and equipment included in accounts payable and accrued expenses



    $                       152



    $                         —

    Issuance of warrants to purchase Class B preferred shares and Class B preferred

       exchangeable shares as a non-cash dividend to preferred shareholders



    $                         —



    $                    1,382

    Deferred offering costs included in accounts payable and accrued expenses



    $                         —



    $                    1,740

     

    FUSION PHARMACEUTICALS INC.

    RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL RESULTS

    (In thousands)

    (Unaudited)















    Three Months Ended

    March 31,





    2021



    2020

    GAAP Net loss



    $                (17,529)



    $                (10,222)

    Less: Adjustments









    Change in fair value of preferred share tranche right liability





    (1,118)

    Change in fair value of preferred share warrant liability





    (334)

    Non-GAAP Net loss



    $                (17,529)



    $                  (8,770)

     

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  13. HAMILTON, ON and BOSTON, May 6, 2021 /PRNewswire/ -- Fusion Pharmaceuticals Inc. (NASDAQ:FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced that it has entered into a clinical trial collaboration with a subsidiary of Merck (known as MSD outside the U.S. and Canada) to evaluate Fusion's lead candidate, [225Ac]-FPI-1434 (FPI-1434), in combination with Merck's anti-PD-1 (programmed death receptor-1) therapy, KEYTRUDA® (pembrolizumab), in patients with solid tumors expressing insulin-like growth factor 1 receptor (IGF-1R).

    "With our strong preclinical data demonstrating promising activity with FPI-1434 and immuno-oncology agents, we believe we have an opportunity to improve efficacy in tumor indications where KEYTRUDA is approved, and to potentially expand into new tumor indications," said Chief Executive Officer John Valliant, Ph.D. "This collaboration with Merck builds off our research on the mechanism of action of alpha radiation and aligns with our goal to expand the utility of radiopharmaceutical therapies, including advancing into earlier lines of cancer therapy."

    The planned Phase 1/2 combination trial will evaluate safety, tolerability and pharmacokinetics of FPI-1434 in combination with pembrolizumab and is expected to initiate approximately six to nine months after achieving the recommended Phase 2 dose in the ongoing Phase 1 study of FPI-1434 monotherapy. Under the terms of the agreement, Fusion will sponsor the study and Merck will supply KEYTRUDA.

    KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

    About FPI-1434

    FPI-1434 is a radioimmunoconjugate designed to target and deliver alpha emitting medical isotopes to cancer cells expressing IGF-1R, a receptor that is overexpressed on many tumor types. FPI-1434 utilizes Fusion's Fast-Clear linker to connect a human monoclonal antibody that targets IGF-1R with actinium-225, a powerful alpha-emitting isotope with desirable half-life and decay chain properties.

    About Fusion

    Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Employing a proprietary Fast-Clear linker technology, Fusion connects alpha particle emitting isotopes to antibodies and other targeting molecules in order to selectively deliver the alpha emitting payloads to tumors. Fusion's lead program, FPI-1434, is currently in a Phase 1 clinical trial.

    Forward-Looking Statements

    Certain statements set forth in this press release constitute "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements can be identified by terms such as "believes," "expects," "plans," "potential," "would" or similar expressions and the negative of those terms. Such forward-looking statements involve substantial risks and uncertainties that could cause Fusion's research and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including Fusions' programs' early stage of development, the process of designing and conducting clinical trials, risks relating to business interruptions resulting from the coronavirus (COVID-19) disease outbreak or similar public health crises and other matters that could affect the timing and outcome of our clinical trials and the sufficiency of existing cash to fund operations. Fusion undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the company in general, see Fusion's annual report on Form 10-K for the year ended December 31, 2020 which is available on the Security and Exchange Commission's website at www.sec.gov and Fusion's website at www.fusionpharma.com.

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  14. HAMILTON, ON and BOSTON, April 14, 2021 /PRNewswire/ -- Fusion Pharmaceuticals Inc. (NASDAQ:FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced that the Company will present at the Bloom Burton & Co. Healthcare Investor Conference on Tuesday, April 20, 2021 at 10:30am EDT. Presenting on behalf of Fusion will be Chief Executive Officer John Valliant, Ph.D.

    A live webcast of the event will be available on the "Events and Presentations" page in the "Investors & Media" section of the Company's website at https://ir.fusionpharma.com/events-webcasts. A replay of the webcast will be archived on the Company's website for 90 days following the presentation.  

    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 targeting molecules in order to selectively deliver the alpha emitting payloads to tumors. Fusion's lead program, FPI-1434, is currently in a Phase 1 clinical trial. The Company is advancing a pipeline of targeted radiopharmaceutical cancer therapies for a broad array of tumor types based upon its proprietary platform technology.

     

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  15. Product candidate FPI-1434, when administered with olaparib, resulted in enhanced efficacy against colorectal and lung cancer xenografts

    Combination of IGF-1R targeted alpha therapy with immune checkpoint inhibitors demonstrated enhanced efficacy in colorectal cancer models

    Data featured in e-poster sessions at the 2021 AACR Virtual Annual Meeting

    HAMILTON, ON and BOSTON, April 10, 2021 /PRNewswire/ -- Fusion Pharmaceuticals Inc. (NASDAQ:FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced the presentation of preclinical data at the 2021 American Association for Cancer Research (AACR) Virtual Annual Meeting. The posters will be presented during the Preclinical…

    Product candidate FPI-1434, when administered with olaparib, resulted in enhanced efficacy against colorectal and lung cancer xenografts

    Combination of IGF-1R targeted alpha therapy with immune checkpoint inhibitors demonstrated enhanced efficacy in colorectal cancer models

    Data featured in e-poster sessions at the 2021 AACR Virtual Annual Meeting

    HAMILTON, ON and BOSTON, April 10, 2021 /PRNewswire/ -- Fusion Pharmaceuticals Inc. (NASDAQ:FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced the presentation of preclinical data at the 2021 American Association for Cancer Research (AACR) Virtual Annual Meeting. The posters will be presented during the Preclinical Radiotherapeutics and Combination Immunotherapies sessions taking place today. The posters highlight the potential of Fusion's targeted alpha therapies (TATs) to enable delivery of an alpha particle emitting isotope (actinium-225) as both monotherapies and combination therapies across multiple tumor types.  

    "These data are the result of Fusion's early investments in research to understand the power of combining our potent TATs with the latest generation of cancer therapies, such as checkpoint inhibitors and DNA damage response inhibitors (DDRis), and they reinforce our belief in the potential of our pipeline of TATs to redefine the utility of radiopharmaceuticals in the cancer treatment paradigm," said Fusion Chief Executive Officer John Valliant, Ph.D. "We believe we have an opportunity to advance clinical development of our product candidate FPI-1434 as monotherapy and in combination with these novel agents, leading to more treatment options for patients in earlier lines of therapy."

    In one set of preclinical studies, highlighted in poster number LB130 titled, "Combination of IGF-1R Targeted Alpha Therapy with Olaparib Results in Synergistic Efficacy Against Colorectal and Lung Cancer Xenografts," results demonstrated that the delivery of alpha-particle radiation by FPI-1434 induced double-stranded DNA breaks and apoptosis in treated colorectal cancer tumor xenografts. Co-dosing with the PARP (poly ADP-ribose polymerase) inhibitor olaparib resulted in lower doses required for efficacy of FPI-1434 in lung and colorectal cancer tumor xenografts, supporting the potential clinical development of this combination.

    In an additional set of preclinical studies, highlighted in poster number LB155 titled, "Combination of IGF-1R Targeted Alpha Therapy with Checkpoint Inhibitors Results in Synergistic Efficacy in Colorectal Cancer Syngeneic Model," data showed that treatment with IGF-1R TAT in combination with immune checkpoint inhibitors resulted in complete tumor eradication. Additionally, an increase in antigen-specific CD8 positive T cells and a strong "vaccine" effect were observed with the combination of IGF-1R TAT and immune checkpoint inhibitors, as noted by the prevention of tumor growth in animals that were reinoculated with the same tumor cells.

    About FPI-1434

    FPI-1434 is a radioimmunoconjugate designed to target and deliver alpha emitting medical isotopes to cancer cells expressing IGF-1R, a receptor that is overexpressed on many tumor types. FPI-1434 utilizes Fusion's Fast-Clear linker to connect a human monoclonal antibody that targets IGF-1R with actinium-225, a powerful alpha-emitting isotope with desirable half-life and decay chain properties.

    About Fusion

    Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Employing a proprietary Fast-Clear linker technology, Fusion connects alpha particle emitting isotopes to targeting molecules in order to selectively deliver the alpha emitting payloads to tumors. Fusion's lead program, FPI-1434, is currently in a Phase 1 clinical trial.

    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 product candidate FPI-1434; and the likelihood of success of any ongoing or future clinical trials involving product candidate FPI-1434. 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 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-K for the quarter ended December 31, 2020 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.

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  16. HAMILTON, ON and BOSTON, April 1, 2021 /PRNewswire/ -- Fusion Pharmaceuticals Inc. (NASDAQ:FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced it has completed the acquisition of Ipsen's (Euronext: IPN; ADR; IPSEY) intellectual property and assets related to IPN-1087. IPN-1087 is a small molecule targeting neurotensin receptor 1 (NTSR1), a protein expressed on multiple solid tumor types. Fusion intends to use IPN-1087 to create an alpha-emitting radiopharmaceutical, FPI-2059, targeting solid tumors expressing NTSR1. 

    Under the terms of the agreement, Fusion issued to Ipsen 600,000 shares of its common stock at the time of closing, including shares due upon the achievement of a patent-related milestone which occurred prior to closing. Such shares were issued pursuant to an exemption from the registration requirements of the Securities Act of 1933, as amended. Fusion will also be obligated to pay Ipsen up to an additional €67.5 million upon the achievement of certain development and regulatory milestones; low single-digit royalties on potential future net sales; and up to €350.0 million in net sales milestones, in each case, relating to products covered by the asset purchase agreement. Fusion will be responsible for paying to a third-party licensor up to €70.0 million in development milestone payments and mid-single to low-double-digit royalties on potential future net sales of products covered by the license agreement.

    The closing of the acquisition was subject to the satisfaction of customary closing conditions, including the expiration of the waiting period under the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976. Additional details regarding the financial terms can be found in Fusion's Form 8-K filed with the Securities and Exchange Commission on March 2, 2021.

    About FPI-2059

    FPI-2059 will be a radioconjugate combining actinium-225 with IPN-1087, for development as a targeted alpha therapy for various solid tumors. The molecule targets NTSR1, a promising target for cancer treatment, that is overexpressed in multiple solid tumors. IPN-1087 was in Phase 1 clinical development as a lutetium-177-based radiopharmaceutical for pancreatic ductal adenocarcinoma, colorectal cancer and gastric cancers expressing NTSR1.

    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 targeting molecules in order to selectively deliver the alpha emitting payloads to tumors. Fusion's lead program, FPI-1434, is currently in a Phase 1 clinical trial. The Company is advancing a pipeline of targeted radiopharmaceutical cancer therapies for a broad array of tumor types based upon its proprietary platform technology.

    About Ipsen

    Ipsen is a global mid-size biopharmaceutical company with a focus on transformative medicines in Oncology, Rare Disease and Neuroscience. Ipsen also has a well-established Consumer Healthcare business. With total sales over €2.5 billion in 2020, Ipsen sells more than 20 drugs in over 115 countries, with a direct commercial presence in more than 30 countries. Ipsen's R&D is focused on its innovative and differentiated technological platforms located in the heart of the leading biotechnological and life sciences hubs (Paris-Saclay, France; Oxford, UK; Cambridge, US; Shanghai, China). The Group has about 5,700 employees worldwide. Ipsen is listed in Paris (Euronext: IPN) and in the United States through a Sponsored Level I American Depositary Receipt program (OTC:IPSEY). For more information on Ipsen, visit www.ipsen.com.fr

    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 FPI-2059; the likelihood and success of any future clinical trials involving FPI-2059 or any novel Targeted Alpha Therapies; and the expected benefits of the acquisition of IPN-1087. 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 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; 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 annual report on Form 10-K for the quarter ended December 31, 2020 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.

     

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  17. HAMILTON, ON and BOSTON, April 1, 2021 /PRNewswire/ -- Fusion Pharmaceuticals Inc. (NASDAQ:FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines today announced the appointment of Donald A. Bergstrom, M.D., Ph.D., as a member of the Company's Board of Directors. Dr. Bergstrom, who currently serves as executive vice president, head of research and development at Relay Therapeutics, Inc., a clinical stage precision medicines company, brings to the board more than 15 years of experience in the biopharmaceutical industry.

    "Don's depth of precision oncology and industry experience will be invaluable to us as we continue to progress our Targeted Alpha Therapies (TAT) platform and grow our pipeline of clinical candidates," said Fusion Chief Executive Officer John Valliant, Ph.D. "Additionally, his leadership and understanding of the oncology landscape will provide Fusion with important organizational, strategic and operational guidance during this growth period." 

    Prior to joining Relay Therapeutics in 2018, Dr. Bergstrom served as senior vice president, chief medical officer of Mersana Therapeutics, Inc., a clinical-stage biopharmaceutical company discovering and developing novel antibody-drug-conjugates for the treatment of cancer. Prior to Mersana, Dr. Bergstrom was global head of translational and experimental medicine at Sanofi Oncology and held roles of increasing responsibility in oncology translational medicine and early clinical development at Merck Research Laboratories.

    Dr. Bergstrom holds an M.D. and a Ph.D. from the University of Washington, Seattle and a B.A. from the Johns Hopkins University.

    "I see significant potential to use the Targeted Alpha Therapies (TAT) platform to build a strong portfolio of precision medicines," said Dr. Bergstrom. "I'm excited to join the board, as I share the Fusion team's passion for improving the lives of cancer patients and I look forward to contributing to Fusion's strategic planning and growth."

    The number of seats on the Fusion Board of Directors was increased to nine from eight immediately prior to Dr. Bergstrom's election.

    About Fusion

    Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Employing a proprietary Fast-Clear™ linker technology, Fusion connects alpha particle emitting isotopes to targeting molecules in order to selectively deliver the alpha emitting payloads to tumors. Fusion's lead program, FPI-1434, is currently in a Phase 1 clinical trial.

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  18. - FPI-1434 Phase 1 study is progressing

    - Recent transactions and partnerships expand and diversify Fusion's pipeline of targeted alpha therapies in development to treat a broad array of tumor types

    HAMILTON, ON and BOSTON, March 25, 2021 /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 fourth quarter ended December 31, 2020 and provided an update on clinical and corporate developments.

    "Advancing the Phase 1 clinical study of our lead program, FPI-1434, continues to be our primary focus," said Chief Executive Officer John Valliant, Ph.D. "We are working towards determining the recommended Phase 2 dose, and defining tumor-specific cohorts, which we expect to occur in the first half of 2022."

    Dr. Valliant continued, "Employing Fusion's adaptable platform, we are expanding our pipeline of targeted alpha therapies using different targeting moieties to treat an array of cancers with high unmet medical need. The recent transactions with Ipsen and AstraZeneca expand and diversify our pipeline and underscore the growing interest in harnessing the power of alpha-emitting radiopharmaceuticals to create innovative precision cancer treatments for patients."

    Recent Highlights and Future Milestones

    Corporate Updates

    • On March 2, Fusion announced it has entered into an asset purchase agreement (APA) to acquire Ipsen's intellectual property and assets related to IPN-1087. IPN-1087 is a small molecule targeting neurotensin receptor 1 (NTSR1), a protein expressed on multiple solid tumor types. Fusion intends to utilize its expertise and IPN-1087 to create an alpha-emitting radiopharmaceutical, FPI-2059, targeting solid tumors expressing NTSR1. The Company expects to submit an investigational new drug application in the first half of 2022.

    FPI-1434 Monotherapy

    • In December 2020, Fusion announced that the first patient had been dosed in the multi-dose portion of the Phase 1 study evaluating FPI-1434 in patients with advanced solid tumors. The multi-dose portion follows completion of the single-ascending dose portion of the Phase 1 study, which showed that FPI-1434 was generally well tolerated with no dose limiting toxicities or treatment-related serious adverse events reported to date. The multi-dose portion of the study is enrolling patients at sites in Canada, the United States and Australia. The current patient cohort is being dosed with FPI-1434 at 75kBq/kg with repeat cycles every six weeks up to allowable limits.
    • Fusion anticipates reporting Phase 1 multi-dose safety and imaging data, and the recommended Phase 2 dose/schedule, in the first half of 2022.

    FPI-1434 Combination Therapy

    • Fusion has evaluated FPI-1434 in preclinical studies in combination with approved checkpoint and DNA damage response inhibitors, including PARP inhibitors, and believes the synergies observed could expand the addressable patient populations for FPI-1434 and allow for potential use in earlier lines of treatment.
    • Fusion anticipates the initiation of a Phase 1 combination study with FPI-1434 to occur six to nine months following determination of the recommended Phase 2 dose of FPI-1434 monotherapy.

    FPI-1966

    • FPI-1966 is designed to target and deliver actinium-225 to tumors expressing FGFR3, a protein that is overexpressed in head and neck and bladder cancers. Following the completion of pre-clinical studies, the Company expects to submit an IND for FPI-1966 in the second quarter of 2021.

    Fourth Quarter 2020 Financial Results

    • Cash and Investments: As of December 31, 2020, Fusion held cash, cash equivalents and investments of $299.5 million, compared to cash of $65.3 million as of December 31, 2019. Fusion expects its cash, cash equivalents and investments as of December 31, 2020 will enable the Company to fund its operations through the end of 2023.
    • R&D Expenses: Research and development expenses for the fourth quarter of 2020 were $5.0 million, compared to $3.4 million for the same period in 2019. The increase was primarily related to increased employee-related costs associated with hiring and increases in clinical, preclinical and discovery activities, partially offset by lower manufacturing expenses.
    • G&A Expenses: General and administrative expenses for the fourth quarter of 2020 were $6.6 million, compared to $2.7 million for the same period in 2019. The increase was primarily related to increased salaries, benefits and stock compensation costs due to increased hiring, and increased professional and consulting fees as a result of public company activities.
    • Net Loss: For the fourth quarter of 2020, Fusion reported a net loss of $13.4 million, or $0.32 per share, compared with a net loss of $8.2 million, or $4.25 per share, for the same period in 2019. On a non-GAAP basis, excluding a change in fair value of preferred share tranche right liability, net loss was $5.9 million for the fourth quarter of 2019.

    Impact of COVID-19

    While Fusion has commenced dosing in the multi-dosing portion of the Phase 1 clinical trial of FPI-1434, the Company has experienced moderate delays in patient recruitment and enrollment as a result of COVID-19.

    Fusion is closely monitoring how the spread of COVID-19 is affecting the Company's employees, business, preclinical studies and clinical trials. In response to the COVID-19 pandemic, certain employees have transitioned to working remotely and travel has been restricted. Fusion's research labs are operating but with reduced capacity.

    At this time, there is significant uncertainty relating to the trajectory of the pandemic and whether it may cause further delays in patient study recruitment. The impact of related responses and disruptions caused by the COVID-19 pandemic may result in difficulties or delays in initiating, enrolling, conducting or completing the planned and ongoing trials and the incurrence of unforeseen costs as a result of disruptions in clinical supply or preclinical study or clinical trial delays. The impact of COVID-19 on future results will largely depend on future developments, which are highly uncertain and cannot be predicted with confidence.

    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 targeting molecules in order to selectively deliver the alpha emitting payloads to tumors. Fusion's lead program, FPI-1434, is currently in a Phase 1 clinical trial. The Company is advancing a pipeline of targeted radiopharmaceutical cancer therapies for a broad array of tumor types based upon its proprietary platform technology.

    Forward-Looking Statements

    Certain statements set forth in this press release constitute "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements can be identified by terms such as "believes," "expects," "plans," "potential," "would" or similar expressions and the negative of those terms. Such forward-looking statements involve substantial risks and uncertainties that could cause Fusion's research and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including Fusions' programs' early stage of development, the ability to move in-licensed targets forward in the clinic,  the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, Fusion's ability to successfully establish, protect and defend its intellectual property, risks relating to business interruptions resulting from the coronavirus (COVID-19) disease outbreak or similar public health crises and other matters that could affect the sufficiency of existing cash to fund operations. Fusion undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the company in general, see Fusion's quarterly report on Form 10-Q for the quarter ended September 30, 2020 which is available on the Securities and Exchange Commission's website at www.sec.gov and Fusion's website at www.fusionpharma.com



     

    FUSION PHARMACEUTICALS INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (In thousands, except share amounts)

    (Unaudited)

     









    December 31,





    2020



    2019

    Assets









    Current assets:









    Cash and cash equivalents



    $                  90,517



    $                  65,344

    Short-term investments



    131,882



    Prepaid expenses and other current assets



    5,340



    929

    Restricted cash



    425



    280

    Total current assets



    228,164



    66,553

    Property and equipment, net



    1,967



    1,272

    Deferred tax assets



    653



    78

    Restricted cash



    1,466



    1,497

    Long-term investments



    77,082



    Other non-current assets



    1,344



    Total assets



    $                310,676



    $                  69,400

    Liabilities, Non-Controlling Interest, Convertible Preferred Shares and Shareholders'

    Equity (Deficit)









    Current liabilities:









    Accounts payable



    $                    3,399



    $                       830

    Accrued expenses



    4,659



    3,326

    Income taxes payable



    2,799



    117

    Deferred revenue



    1,000



    Total current liabilities



    11,857



    4,273

    Deferred rent, net of current portion



    11



    28

    Deferred revenue, net of current portion



    4,000



    Preferred share tranche right liability





    5,741

    Income taxes payable, net of current portion



    295



    293

    Special voting shares redemption right liability





    Total liabilities



    16,163



    10,335

    Commitments and contingencies









    Non-controlling interest in Fusion Pharmaceuticals (Ireland) Limited





    20,961

    Convertible preferred shares, no par value; 0 shares and 132,207,290 shares authorized as of

    December 31, 2020 and 2019, respectively; 0 shares and 73,125,790 shares issued and

    outstanding as of December 31, 2020 and 2019, respectively; aggregate liquidation

    preference of $0 and $77,965 as of December 31, 2020 and 2019, respectively





    71,592

    Shareholders' equity (deficit):









    Common shares, no par value, unlimited shares authorized as of December 31, 2020 and

    2019; 41,725,797 shares and 1,929,555 shares issued and outstanding as of December 31,

    2020 and 2019, respectively





    Additional paid-in capital



    407,672



    1,286

    Accumulated other comprehensive income



    44



    Accumulated deficit



    (113,203)



    (34,774)

    Total shareholders' equity (deficit)



    294,513



    (33,488)

    Total liabilities, non-controlling interest, convertible preferred shares and

    shareholders' equity (deficit)



    $                310,676



    $                  69,400











     

     

    FUSION PHARMACEUTICALS INC.

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

    (In thousands, except share and per share amounts)

    (Unaudited)

     







    Three Months Ended December 31,



    Year Ended December 31,





    2020



    2019



    2020



    2019

    Operating expenses:

















    Research and development



    $                    4,960



    $                    3,416



    $                  17,191



    $                  10,632

    General and administrative



    6,639



    2,724



    20,744



    7,588

    Total operating expenses



    11,599



    6,140



    37,935



    18,220

    Loss from operations



    (11,599)



    (6,140)



    (37,935)



    (18,220)

    Other income (expense):

















    Change in fair value of preferred share tranche right liability





    (2,275)



    (32,722)



    1,432

    Change in fair value of preferred share warrant liability







    (6,399)



    Interest income (expense), net



    78



    181



    327



    576

    Refundable investment tax credits



    (139)



    44





    176

    Other income (expense), net



    859



    22



    1,007



    98

    Total other income (expense), net



    798



    (2,028)



    (37,787)



    2,282

    Loss before provision for income taxes



    (10,801)



    (8,168)



    (75,722)



    (15,938)

    Income tax provision



    (2,584)



    (38)



    (2,611)



    (251)

    Net loss



    $                (13,385)



    $                  (8,206)



    $                (78,333)



    $                (16,189)

    Unrealized gain on investments



    45





    44



    Comprehensive loss



    $                (13,340)



    $                  (8,206)



    $                (78,289)



    $                (16,189)

    Reconciliation of net loss to net loss attributable to common shareholders:

















    Net loss



    $                (13,385)



    $                  (8,206)



    $                (78,333)



    $                (16,189)

    Dividends paid to preferred shareholders in the form of warrants issued







    (1,382)



    Net loss attributable to common shareholders



    (13,385)



    (8,206)



    (79,715)



    (16,189)

    Net loss per share attributable to common shareholders—basic and diluted



    $                    (0.32)



    $                    (4.25)



    $                    (3.62)



    $                    (8.45)

    Weighted-average common shares outstanding—basic and diluted



    41,722,234



    1,929,555



    22,033,269



    1,915,604



















     

    FUSION PHARMACEUTICALS INC.

    CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

    (In thousands)

    (Unaudited)







    Year Ended December 31,





    2020



    2019

    Cash flows from operating activities:









    Net loss



    $                (78,333)



    $                (16,189)

    Adjustments to reconcile net loss to net cash used in operating activities:









    Share-based compensation expense



    3,368



    618

    Depreciation and amortization expense



    482



    290

    Non-cash rent expense



    25



    (3)

    Change in fair value of preferred share tranche right liability



    32,722



    (1,432)

    Change in fair value of preferred share warrant liability



    6,399



    Amortization of premiums (accretion of discounts) on investments, net



    410



    Deferred tax benefit



    (576)



    (59)

    Changes in operating assets and liabilities:









    Prepaid expenses and other current assets



    (4,454)



    259

    Other non-current assets



    (1,344)



    Accounts payable



    2,558



    479

    Accrued expenses



    1,291



    2,132

    Deferred revenue



    5,000



    Income taxes payable



    2,685



    215

    Net cash used in operating activities



    (29,767)



    (13,690)

    Cash flows from investing activities:









    Purchases of investments



    (219,030)



    Maturities of investments



    9,700



    Purchases of property and equipment



    (1,123)



    (456)

    Net cash used in investing activities



    (210,453)



    (456)

    Cash flows from financing activities:









    Proceeds from issuance of Class B convertible preferred shares and Class B preferred share

    tranche right, net of issuance costs



    65,676



    45,476

    Proceeds from issuance of Class B preferred exchangeable shares of Fusion Pharmaceuticals

    (Ireland) Limited and Class B preferred share tranche right, net of issuance costs



    6,722



    6,711

    Proceeds from the issuance of common shares upon closing of initial public offering, net of

    underwriter fees



    197,625



    Payment of offering costs



    (4,572)



    Proceeds from issuance of common shares upon exercise of stock options



    56



    Net cash provided by financing activities



    265,507



    52,187

    Net increase in cash, cash equivalents and restricted cash



    25,287



    38,041

    Cash, cash equivalents and restricted cash at beginning of period



    $                  67,121



    $                  29,080

    Cash, cash equivalents and restricted cash at end of period



    $                  92,408



    $                  67,121

    Supplemental disclosure of cash flow information:









    Cash paid for income taxes



    $                       501



    $                         95

    Supplemental disclosure of non-cash investing and financing activities:









    Purchases of property and equipment included in accounts payable and accrued expenses



    $                         35



    $                         24

    Issuance of warrants to purchase Class B preferred shares and Class B preferred

    exchangeable shares as a non-cash dividend to preferred shareholders



    $                    1,382



    $                         —

    Issuance of common shares upon net settlement of stock option exercise



    $                         —



    $                         57











     

    FUSION PHARMACEUTICALS INC.

    RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL RESULTS

    (In thousands)

    (Unaudited)























    Three Months Ended

    December 31,



    Year Ended

    December 31,





    2020



    2019



    2020



    2019

    GAAP Net loss



    $                (13,385)



    $                  (8,206)



    $                (78,333)



    $                (16,189)

    Less: Adjustments

















    Change in fair value of preferred share tranche right liability





    (2,275)



    (32,722)



    1,432

    Change in fair value of preferred share warrant liability







    (6,399)



    Non-GAAP Net loss



    $                (13,385)



    $                  (5,931)



    $                (39,212)



    $                (17,621)

     

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  19. Fusion to Leverage its Targeted Alpha Therapies (TAT) Expertise to Create FPI-2059, an Alpha-Emitting Radiopharmaceutical Targeting Solid Tumors

    HAMILTON, ON and BOSTON, March 2, 2021 /PRNewswire/ -- Fusion Pharmaceuticals Inc. (NASDAQ:FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced it has entered into an asset purchase agreement (APA) to acquire Ipsen's (Euronext: IPN; ADR; IPSEY) intellectual property and assets related to IPN-1087. IPN-1087 is a small molecule targeting neurotensin receptor 1 (NTSR1), a protein expressed on multiple solid tumor types.  Fusion intends to use IPN-1087 to create an alpha-emitting radiopharmaceutical, FPI-2059, targeting…

    Fusion to Leverage its Targeted Alpha Therapies (TAT) Expertise to Create FPI-2059, an Alpha-Emitting Radiopharmaceutical Targeting Solid Tumors

    HAMILTON, ON and BOSTON, March 2, 2021 /PRNewswire/ -- Fusion Pharmaceuticals Inc. (NASDAQ:FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced it has entered into an asset purchase agreement (APA) to acquire Ipsen's (Euronext: IPN; ADR; IPSEY) intellectual property and assets related to IPN-1087. IPN-1087 is a small molecule targeting neurotensin receptor 1 (NTSR1), a protein expressed on multiple solid tumor types.  Fusion intends to use IPN-1087 to create an alpha-emitting radiopharmaceutical, FPI-2059, targeting solid tumors expressing NTSR1. 

    "The acquisition of IPN-1087 augments and further diversifies our pipeline of potent alpha-emitting radiopharmaceuticals and leverages our expertise to create targeted alpha therapies (TATs) using different classes of targeting molecules," said Chief Executive Officer John Valliant, Ph.D. "In clinical imaging studies, IPN-1087, which targets an established tumor target, has shown uptake in multiple tumor types. Combining IPN-1087 with the power of actinium-225, an alpha-emitter, we believe FPI-2059 will precisely target and kill tumor cells, leading to a significant opportunity to advance the treatment of high unmet need diseases, such as colorectal cancer and pancreatic ductal adenocarcinoma (PDAC)."

    Under the terms of the APA, Fusion will issue to Ipsen 400,000 shares of its common stock upon closing and an additional 200,000 shares upon the achievement of a patent-related milestone. Such shares will be issued pursuant to an exemption from the registration requirements of the Securities Act of 1933, as amended. Fusion will also be obligated to pay Ipsen up to an additional €67.5 million upon the achievement of certain development and regulatory milestones; low single-digit royalties on potential future net sales; and up to €350.0 million in net sales milestones, in each case, relating to products covered by the APA. Fusion will be responsible for paying to a third-party licensor up to €70.0 million in development milestone payments and mid-single to low-double-digit royalties on potential future net sales of products covered by the license agreement.

    Covington & Burling and Goodwin Proctor represented Fusion as legal advisors in the transaction. Barclays represented Ipsen as exclusive financial advisor and Hogan Lovells acted as Ipsen's legal advisor.

    About FPI-2059

    FPI-2059 will be a radioconjugate combining actinium-225 with IPN-1087, for development as a targeted alpha therapy for various solid tumors. The molecule targets NTSR1, a promising target for cancer treatment, that is overexpressed in multiple solid tumors.  IPN-1087 was in Phase 1 clinical development as a lutetium-177-based radiopharmaceutical for pancreatic ductal adenocarcinoma, colorectal cancer and gastric cancers expressing NTSR1.

    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 antibodies and other targeting molecules in order to selectively deliver the alpha emitting payloads to tumors. Fusion's lead program, FPI-1434, is currently in a Phase 1 clinical trial. The Company is advancing a pipeline of targeted radiopharmaceutical cancer therapies for a broad array of tumor types based upon its proprietary platform technology.

    About Ipsen

    Ipsen is a global mid-size biopharmaceutical company with a focus on transformative medicines in Oncology, Rare Disease and Neuroscience. Ipsen also has a well-established Consumer Healthcare business. With total sales over €2.5 billion in 2020, Ipsen sells more than 20 drugs in over 115 countries, with a direct commercial presence in more than 30 countries. Ipsen's R&D is focused on its innovative and differentiated technological platforms located in the heart of the leading biotechnological and life sciences hubs (Paris-Saclay, France; Oxford, UK; Cambridge, US; Shanghai, China). The Group has about 5,700 employees worldwide. Ipsen is listed in Paris (Euronext: IPN) and in the United States through a Sponsored Level I American Depositary Receipt program (OTC:IPSEY). For more information on Ipsen, visit www.ipsen.com.fr

    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 FPI-2059; the likelihood and success of any future clinical trials involving FPI-2059 or any novel Targeted Alpha Therapies; and the expected benefits of the acquisition of IPN-1087. 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 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 September 30, 2020 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.

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  20. HAMILTON, ON and BOSTON, Feb. 23, 2021 /PRNewswire/ -- Fusion Pharmaceuticals Inc. (NASDAQ:FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced that the Company will participate in the "Novel Oncology Targets" panel discussion at the Cowen 41st Annual Health Care Conference on Monday, March 1, 2021 at 1:20pm EST. Presenting on behalf of Fusion will be Chief Executive Officer John Valliant, Ph.D.

    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 antibodies and other targeting molecules in order to selectively deliver the alpha emitting payloads to tumors. Fusion's lead program, FPI-1434, is currently in a Phase 1 clinical trial. The Company is advancing a pipeline of targeted radiopharmaceutical cancer therapies for a broad array of tumor types based upon its proprietary platform technology.

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    SOURCE Fusion Pharmaceuticals Inc.

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  21. HAMILTON, Ontario and BOSTON, Feb. 11, 2021 /PRNewswire/ -- Fusion Pharmaceuticals Inc. (NASDAQ:FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced the appointment of Philina Lee, Ph.D., as a member of the Company's Board of Directors. Dr. Lee, who currently serves as senior vice president, head of portfolio strategy at Blueprint Medicines Corporation, brings to the board 15 years of experience in the biopharmaceutical industry. She previously was head of U.S. marketing for Algeta, developer of the first marketed alpha-emitting radiopharmaceutical.

    "Philina's depth of both precision oncology and radiopharmaceutical industry experience will be valuable to us as we continue to progress our Targeted Alpha Therapies (TAT) platform and grow our pipeline of clinical candidates," said Fusion Chief Executive Officer John Valliant, Ph.D. "Additionally, her leadership and understanding relating to the commercial launch of an alpha therapy product will provide Fusion with important organizational, strategic and operational guidance during this growth period." 

    Dr. Lee joined Blueprint Medicines in 2014 and has served in positions of increasing responsibility, including leading new product strategy, establishing the commercial organization, building infrastructure to enable patient access, and leading multiple new product launches. In her current role she is responsible for providing strategic and operational leadership across the portfolio, leading the portfolio management team as well as the program leadership and program management functions.

    Prior to joining Blueprint Medicines, Dr. Lee served as head of U.S. marketing at Algeta ASA, where she was the second hire in the U.S. In this role, she contributed to building the fully-integrated organization that successfully launched Xofigo® (radium-223 dichloride), a first-in-class alpha-emitting radiopharmaceutical. Algeta was acquired by Bayer AG in 2014.

    Dr. Lee holds a Ph.D. from the Massachusetts Institute of Technology and a B.S. from the University of Alberta.

    "I see significant potential to use Fusion's Targeted Alpha Therapies (TAT) platform to build a strong portfolio of precision medicines," said Dr. Lee. "I'm excited to join the board, as I share the Fusion team's passion for improving the lives of cancer patients. I look forward to contributing to Fusion's strategic planning and growth."

    The number of seats on the Fusion Board of Directors was increased to eight from seven immediately prior to Dr. Lee's election.

    About Fusion

    Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Employing a proprietary Fast-Clear™ linker technology, Fusion connects alpha particle emitting isotopes to antibodies and other targeting molecules in order to selectively deliver the alpha emitting payloads to tumors. Fusion's lead program, FPI-1434, is currently in a Phase 1 clinical trial.

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    SOURCE Fusion Pharmaceuticals Inc.

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  22. TORONTO, Jan. 5, 2021 /CNW/ - While the US initial public offering (IPO) and special purpose acquisition corporation (SPAC) market experienced an unprecedent boom in 2020, Canadian IPO market continued to struggle with mixed results.

    77 IPOs including capital pool companies (CPCs) and SPACs were completed in 2020 on four Canadian stock exchanges, raising $5.55 billion in aggregate gross proceeds, or excluding CPCs and SPACs, 43 IPOs for $4.85 billion.

    The 2020 IPO numbers represent a decrease of 29% in total number of IPOs and an increase of 116% in total amount or, excluding CPC/SPAC IPOs, a decrease of 7% in total IPO number and an increase of 605% in total amount from 2019.

    Excluding CPC/SPAC IPOs, CSE continues to lead all Canadian exchanges with 25 IPOs (58%), comparing to 31 IPOs (67%) in 2019. 

    Mining issuers led all sectors with 23 IPOs for $324 million, accounting for 53% and 7% of the total number of Non-CPC/SPAC IPOs and total amount respectively.

    4 Private Equity (PE) and 2 Venture Capital (VC) backed IPOs dominated the total amount, raising $3,395 million and $144 million respectively, or $3,539 million in aggregate, representing 64% of total IPO amount or 73% of total Non-CPC/SPAC IPO amount.

    2020 IPO Breakdown by Exchanges (Non-CPC/SPAC)

    • CSE – 25 IPOs for $43 million (25 IPOs for $43 million)
    • TSX – 11 IPO for $4,726 million (10 IPOs for $4,460 million)
    • TSX Venture Exchange – 39 IPOs for $364 million (8 IPOs for $350 million)
    • NEO – 2 IPOs for $421 million (nil)

    2020 Canadian IPOs League Table – Top 8 Law Firms (by # IPOs only)

    All IPO Ranking (#, $total IPO value)

    1. Miller Thomson LLP (13, $17M)
    2. Blake, Cassels & Graydon LLP (11, $1,549M)
    3. DuMoulin Black LLP (8, $17M)
    4. Cassels Brock & Blackwell LLP (7, $38M)
    5. Harper Grey LLP (7, $10M)
    6. MLT Aikins LLP (7, $5M)
    7. Peterson McVicar LLP (7, $2M)
    8. Borden Ladner Gervais LLP (6, $12M)

    Non-CPC/SPAC IPO Ranking (#, $total IPO value)

    1. Blake, Cassels & Graydon LLP (8, $861M)
    2. Miller Thomson LLP (7, $16M)
    3. Stikeman Elliott LLP (5, $2,165M)
    4. DuMoulin Black LLP (5, $16M)
    5. Harper Grey LLP (5, $10M)
    6. Cassels Brock & Blackwell LLP (4, $37M)
    7. Vantage Law Corporation (4, $6M)
    8. Lotz & Company (4, $2M)

    2020 Canadian IPOs League Table – Top 13 Underwriters (by # IPOs Only)

    All IPO Ranking (#, $total IPO value)

    1. Canaccord Genuity Corp. (26, $2,535M)
    2. Haywood Securities Inc. (24, $ 25M)
    3. BMO Nesbitt Burns Inc. (12, $ 4,651M)
    4. Scotia Capital Inc. (9, $4,349M)
    5. CIBC World Markets Inc. (8, $4,372M)
    6. Leede Jones Gable Inc. (8, $12M)
    7. Raymond James Ltd. (7, $4,053M)
    8. TD Securities Inc. (7, $4,045M)
    9. National Bank Financial Inc. (7, $4,039M)
    10. Industrial Alliance Securities Inc. (7, $1,017M)
    11. Mackie Research Capital Corporation (7, $9M)
    12. RBC Dominion Securities Inc. (6, $4,006M)
    13. Stifel Nicolaus Canada Inc. (6, $3,623M)

    Non-CPC/SPAC IPO Ranking (#, $total IPO value)

    1. Canaccord Genuity Corp. (17, $1,846M)
    2. BMO Nesbitt Burns Inc. (12, $4,651M)
    3. Haywood Securities Inc. (9, $20M)
    4. Scotia Capital Inc. (9, $4,349M)
    5. CIBC World Markets Inc. (8, $4,372M)
    6. Raymond James Ltd. (7, $4,053M)
    7. TD Securities Inc. (7, $4,045M)
    8. National Bank Financial Inc. (7, $4,039M)
    9. RBC Dominion Securities Inc. (6, $4,006M)
    10. Stifel Nicolaus Canada Inc. (6, $3,623M)
    11. Leede Jones Gable Inc. (6, $12M)
    12. Mackie Research Capital Corporation (6, $8M)
    13. Desjardins Securities Inc.  (5, $952M)

    2020 Top Five Canadian IPOs (Canadian and foreign exchanges)

    Three of top five Canadian IPOs were done on the NASDAQ Exchange. The Top Five are backed either by private equity or venture capital firms.

    Issuer

    Backed

    Close Date

    $ Raised (Mil)

    Exchange(s)

    Valuation* ($Mil)

    GFL Environmental Inc.

    PE

    2020-03-05

    $1,425 (US)

    TSX/NYSE: GFL

    $6,416 (US)

    Nuvei Corporation

    PE

    2020-09-22

    $805 (US)

    TSX: NVEI

    $3,390 (US)

    AbCellera Biologics Inc.

    VC

    2020-12-15

    $555 (US)

    NASDAQ: ABCL

    $5,384 (US)

    Repare Therapeutics Inc.

    VC

    2020-06-23

    $253 (US)

    NASDAD: RPTX

    $700 (US)

    Fusion Pharmaceuticals Inc.

    VC

    2020-06-30

    $213 (US)

    NASDAQ: FUSN

    $708 (US)

    Report Summary

    2020 Canadian IPO Report Summary can be downloaded from financings.ca https://www.financings.ca/reports/

    About CPE Analytics

    CPE Analytics, through financings.ca, is Canada's all public and private financing data provider. We offer comprehensive data coverage and analysis on private capital and public financings, IPOs, M&As and VC/PE fundraising. More information:  https://cpeanalytics.ca

    CPE Analytics is a division of CPE Media Inc., Canada's all financing news and data provider.

    SOURCE CPE Media Inc.

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  23. VANCOUVER, British Columbia, Dec. 16, 2020 (GLOBE NEWSWIRE) -- TRIUMF, Canada's particle accelerator centre, today announced it has entered into a collaboration agreement with Fusion Pharmaceuticals Inc. (NASDAQ:FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Under the agreement, Fusion will provide a financial investment enabling TRIUMF to upgrade its actinium-225 production infrastructure, and in return will receive preferred access to actinium-225, a rare medical isotope that shows great promise in new, cutting-edge cancer therapies.

    An alpha-emitting isotope with a short half-life, actinium-225 can be combined with a molecular agent that specifically targets cancer…

    VANCOUVER, British Columbia, Dec. 16, 2020 (GLOBE NEWSWIRE) -- TRIUMF, Canada's particle accelerator centre, today announced it has entered into a collaboration agreement with Fusion Pharmaceuticals Inc. (NASDAQ:FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Under the agreement, Fusion will provide a financial investment enabling TRIUMF to upgrade its actinium-225 production infrastructure, and in return will receive preferred access to actinium-225, a rare medical isotope that shows great promise in new, cutting-edge cancer therapies.

    An alpha-emitting isotope with a short half-life, actinium-225 can be combined with a molecular agent that specifically targets cancer cells, seeking out and destroying the cancer while leaving the surrounding tissue unharmed. The new collaboration will enable TRIUMF to significantly increase its production and delivery of actinium-225.

    "Today's announcement marks an important step in positioning Canada to play a leading role in the development and deployment of next-generation radiotherapies, and in ensuring that researchers and patients around the world have a stable supply of life-saving medical isotopes," said Dr. Jonathan Bagger, Director of TRIUMF. "Enabled by decades of public investment in TRIUMF's infrastructure and research programs, this collaboration recognizes the laboratory's capacity to drive innovation, moving this promising treatment closer to market."

    "Given Fusion's opportunity to expand our pipeline of actinium-based Targeted Alpha Therapies (TATs), and the importance of isotope production in the supply chain of radiopharmaceuticals, we will continue to proactively address and prioritize actinium supply in our strategic plans," said Dr. John Valliant, Chief Executive Officer of Fusion. "We are excited to collaborate with TRIUMF, a leader in isotope production, as part of these plans."

    "With its Targeted Alpha Therapy platform technology, Fusion has an opportunity to impact the cancer treatment landscape," said Kathryn Hayashi, Chief Executive Officer of TRIUMF Innovations. "Through this collaboration agreement, we are partnering with a premier developer of innovative radiotherapies to deepen TRIUMF's leadership position in isotope production to help save the lives of patients in Canada and around the world".

    Read more about the announcement here.

    About TRIUMF

    TRIUMF is Canada's particle accelerator centre. The lab is a hub for discovery and innovation, inspired by a half-century of ingenuity in answering some of nature's most challenging questions. From the hunt for the smallest particles in the universe to the development of new technologies, TRIUMF is pushing frontiers in research, while training the next generation of leaders in science, medicine, and business. Learn more about TRIUMF's work to produce more actinium-225 here.

    Discover more at www.triumf.ca and connect on Facebook, Twitter, and Instagram: @TRIUMFLab.

    About TRIUMF Innovations

    TRIUMF Innovations Inc. is TRIUMF's business interface and commercialization arm, connecting Canada's particle accelerator centre to the private sector via industry partnerships, licensing, and company creation. TRIUMF Innovations provides pathways for businesses to access the expertise and infrastructure at TRIUMF and across the TRIUMF network.

    Learn more at www.triumfinnovations.ca and connect on Twitter at @TRIUMFInno.

    Media Contact:

    Kamran Shaikh

    PR Associates

    7788465406

    kshaikh@prassociates.com



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  24. Phase 1 Single-Dose Data Show Uptake Across Multiple Tumor Types; No Dose Limiting Toxicities or Treatment-Related Serious Adverse Events

    HAMILTON, ON and BOSTON, Dec. 10, 2020 /PRNewswire/ -- Fusion Pharmaceuticals Inc. (NASDAQ:FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced that the first patient has been dosed in the multi-dose portion of the Phase 1 study evaluating [225Ac]-FPI-1434 (FPI-1434) in patients with advanced solid tumors. FPI-1434 is a radioimmunoconjugate that utilizes Fusion's proprietary Fast-Clear™ linker to connect a humanized monoclonal antibody targeting the insulin-like growth factor 1 receptor (IGF-1R), with the alpha-emitting…

    Phase 1 Single-Dose Data Show Uptake Across Multiple Tumor Types; No Dose Limiting Toxicities or Treatment-Related Serious Adverse Events

    HAMILTON, ON and BOSTON, Dec. 10, 2020 /PRNewswire/ -- Fusion Pharmaceuticals Inc. (NASDAQ:FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced that the first patient has been dosed in the multi-dose portion of the Phase 1 study evaluating [225Ac]-FPI-1434 (FPI-1434) in patients with advanced solid tumors. FPI-1434 is a radioimmunoconjugate that utilizes Fusion's proprietary Fast-Clear™ linker to connect a humanized monoclonal antibody targeting the insulin-like growth factor 1 receptor (IGF-1R), with the alpha-emitting isotope actinium-225, creating a targeted alpha therapy (TAT).

    The Phase 1, multi-center, open-label clinical trial is designed to investigate the safety, tolerability and pharmacokinetics of FPI-1434 in patients with solid tumors expressing IGF-1R.  The trial is also designed to establish the maximum tolerated dose for FPI-1434 and the recommended Phase 2 dose. As part of the precision medicine approach, prior to receiving the therapeutic injection of FPI-1434, patients are administered an indium-111 imaging analogue, [111In]-FPI-1547 (FPI-1547). The images collected are used to confirm the presence of tumor uptake and to ensure that estimated radiation doses to organs and tissues are below protocol-specified safety limits.

    The multi-dose study follows completion of the single-dose portion of the Phase 1 study, which showed that FPI-1434 was generally well tolerated with no dose limiting toxicities or treatment-related serious adverse events reported to date. The multi-dose portion of the study is expected to enroll patients at sites in Canada, the United States and Australia. The initial patient cohort is being dosed with FPI-1434 at 75kBq/kg with repeat cycles every six weeks up to allowable limits.

    "We are pleased with the results of the single-dose portion of our Phase 1 study of FPI-1434 which, following the evaluation of the Safety Review Committee, support initiating the multi-dosing portion of the study," said Chief Executive Officer John Valliant, Ph.D. "This is a critical next step in the FPI-1434 development program as data from the multi-dose portion of the study may provide important insights on potential anti-tumor activity. The multi-dosing trial will also inform the design of the Phase 2 program and assist in the selection of tumor indications to be pursued in planned expansion cohorts. This is especially important given the broad expression of IGF-1R across multiple tumor types."  

    For additional detail about the study, please visit https://clinicaltrials.gov/ct2/show/NCT03746431.

    About FPI-1434

    FPI-1434 is a radioimmunoconjugate designed to target and deliver alpha emitting medical isotopes to cancer cells expressing IGF-1R, a receptor that is overexpressed on many tumor types. FPI-1434 utilizes Fusion's Fast-Clear linker to connect a human monoclonal antibody that targets IGF-1R with actinium-225, a powerful alpha-emitting isotope with desirable half-life and decay chain properties.

    Acknowledgement of US DOE and Actiunium-225 Supply

    The actinium-225 used in this research was supplied by the United States Department of Energy Office of Science by the Isotope Program in the Office of Nuclear Physics.

    About Fusion

    Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Employing a proprietary Fast-Clear linker technology, Fusion connects alpha particle emitting isotopes to antibodies and other targeting molecules in order to selectively deliver the alpha emitting payloads to tumors. Fusion's lead program, FPI-1434, is currently in a Phase 1 clinical trial.

    Forward-Looking Statements

    Certain statements set forth in this press release constitute "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements can be identified by terms such as "believes," "expects," "plans," "potential," "would" or similar expressions and the negative of those terms. Such forward-looking statements involve substantial risks and uncertainties that could cause Fusion's research and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including Fusions' programs' early stage of development, the process of designing and conducting and clinical trials, , risks relating to business interruptions resulting from the coronavirus (COVID-19) disease outbreak or similar public health crises and other matters that could affect the sufficiency of existing cash to fund operations. Fusion undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the company in general, see Fusion's quarterly report on Form 10-Q for the quarter ended September 30, 2020 which is available on the Security and Exchange Commission's website at www.sec.gov and Fusion's website at www.fusionpharma.com

     

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  25. HAMILTON, Ontario and BOSTON, Nov. 12, 2020 /PRNewswire/ -- Fusion Pharmaceuticals Inc. (NASDAQ:FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced that the Company will participate in a "fireside chat" presentation at the Jefferies Virtual London Healthcare Conference on Thursday, November 19, 2020 at 8:30am EST / 1:30pm GMT. Presenting on behalf of Fusion will be Chief Executive Officer John Valliant, Ph.D., Chief Financial Officer John Crowley, and Chief Medical Officer James O'Leary, M.D.

    A live webcast of the event will be available on the "Events and Presentations" page in the "Investors and Media" section of the Company's website at https://ir.fusionpharma.com/events-webcasts. A replay of the webcast will be archived on the Company's website for 90 days following the presentation.  

    About Fusion

    Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Employing a proprietary Fast-Clear linker technology, Fusion connects alpha particle emitting isotopes to antibodies and other targeting molecules in order to selectively deliver the alpha emitting payloads to tumors. Fusion's lead program, FPI-1434, is currently in a Phase 1 clinical trial.

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  26. - Multi-dosing portion of Fusion's Phase 1 study of FPI-1434 on track to be initiated in Q4 2020

    - Company executes collaboration agreement with AstraZeneca to grow pipeline of next-generation radiopharmaceuticals

    HAMILTON, ON and BOSTON, Nov. 10, 2020 /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, 2020 and provided an update on clinical and corporate developments.

    "We are pleased with the results of the single-dose portion of our Phase 1 study of FPI-1434 that support our ability to move into the multi-dosing portion, and with trial sites now open, we continue to expect to dose our first patient in the fourth quarter," said Chief Executive Officer John Valliant, Ph.D. "Additionally, Fusion's scalable platform can support a robust pipeline of next-generation radiopharmaceuticals using our precision medicine approach. We recently executed a collaboration agreement with AstraZeneca that allows us to retain commercial rights to our existing products while expanding our pipeline. We are well-positioned with the resources and robust manufacturing and supply chain capabilities to execute on our plans, grow our business and develop potent new cancer treatments for patients in need."

    Recent Highlights and Future Milestones

    Corporate Updates

    • On November 2, Fusion announced that the Company entered into a collaboration with AstraZeneca to develop and commercialize next-generation alpha-emitting radiopharmaceuticals and combination therapies for the treatment of cancer. The collaboration leverages Fusion's Targeted Alpha Therapies (TATs) platform and expertise in radiopharmaceuticals with AstraZeneca's leading portfolio of antibodies and cancer therapeutics, including DNA Damage Response Inhibitors (DDRis). Under the terms of the agreement, the companies will jointly discover, develop and commercialize novel TATs, which will utilize Fusion's Fast-Clear™ linker technology platform with antibodies in AstraZeneca's oncology portfolio. In addition, the companies will explore combination strategies between TATs (including Fusion's lead candidate FPI-1434) and AstraZeneca therapeutics, for the treatment of various cancers. Both companies will retain full rights to their respective assets.

    FPI-1434 Monotherapy

    • Fusion convened a Safety Review Committee (SRC) meeting in the third quarter of 2020 to evaluate the safety of the single-dose cohort of 40kBq/kg (cohort three). The SRC determined the safety data of cohort three allowed Fusion to begin the multi-dosing portion of the study at the next higher planned dose level. The Company expects to dose the first patient in the multi-dosing portion of the study in the fourth quarter of 2020, assuming no delays due to the spread of COVID-19.
    • The available safety, dosimetry, pharmacokinetic and biodistribution data from the single dose escalation portion of the study provided justification for the initiation of FPI-1434 multi-dosing at 75 kBq/kg. Both FPI-1434, and the imaging analogue FPI-1547, have been well tolerated. No dose limiting toxicities or serious adverse events related to study treatment were reported.
    • Fusion anticipates reporting Phase 1 multiple-dose safety and imaging data, and the recommended Phase 2 dose/schedule, approximately nine to eighteen months after commencing this portion of the study.

    FPI-1434 Combination Therapy

    • Fusion has evaluated FPI-1434 in preclinical studies in combination with approved checkpoint and DNA damage response inhibitors, including PARP inhibitors, and believes the synergies observed could expand the addressable patient populations for FPI-1434 and allow for potential use in earlier lines of treatment.
    • Fusion anticipates the initiation of a Phase 1 combination study with FPI-1434 to occur six to nine months following determination of the recommended Phase 2 dose of FPI-1434 monotherapy.

    FPI-1966

    • FPI-1966 is designed to target and deliver Actinium-225 to tumors expressing FGFR3, a protein that is overexpressed in head and neck and bladder cancers. Following the completion of pre-clinical studies, the Company expects to submit an IND for FPI-1966 in the first half of 2021.

    Third Quarter 2020 Financial Results

    • Cash and Investments: As of September 30, 2020, Fusion held cash, cash equivalents and investments of $303.1 million, compared to cash of $65.3 million as of December 31, 2019. Fusion expects its cash, cash equivalents and investments as of September 30, 2020 will enable the Company to fund its operations into 2024.
    • R&D Expenses: Research and development expenses for the third quarter of 2020 were $4.5 million, compared to $2.2 million for the same period in 2019. The increase was primarily due to costs related to our Phase 1 clinical trial of FPI-1434, as well as other development and personnel-related costs.
    • G&A Expenses: General and administrative expenses for the third quarter of 2020 were $5.8 million, compared to $1.9 million for the same period in 2019. The increase was primarily due to an increase in professional fees, personnel-related costs and other costs including general corporate, insurance and facilities costs.
    • Net Loss: For the third quarter of 2020, Fusion reported a net loss of $10.0 million, or $0.24 per share, compared with a net loss of $0.6 million, or $0.31 per share, for the same period in 2019. On a non-GAAP basis, excluding a change in fair value of preferred share tranche right liability, net loss was $4.1 million for the third quarter of 2019.

    Upcoming Events

    • Fusion will participate in a virtual "fireside chat" presentation at the Jefferies Virtual London Healthcare Conference on Thursday, November 19 at 1:30pm GMT / 8:30am EST.

    Impact of COVID-19

    Fusion is closely monitoring how the spread of COVID-19 is affecting the Company's employees, business, preclinical studies and clinical trials. In response to the COVID-19 pandemic, certain employees have transitioned to working remotely and travel has been restricted. Fusion's research labs are operating but with reduced capacity.

    While Fusion has completed enrollment, dosing and the DLT evaluation period for the third patient cohort in the ongoing Phase 1 clinical trial of FPI-1434, the Company may not be able to enroll additional patient cohorts on the planned timeline due to disruptions at clinical trial sites. Additionally, while certain preclinical activities have restarted, Fusion is currently unable to predict when the Company will fully resume all preclinical activities.

    Although the single dose Phase 1 clinical trial has not been materially affected by the COVID-19 pandemic as of September 30, 2020, at this time, there is significant uncertainty relating to the trajectory of the pandemic and whether or not it may cause a delay in the dosing of the first patient in the multi-dosing portion of the study. The impact of related responses and disruptions caused by the COVID-19 pandemic may result in difficulties or delays in initiating, enrolling, conducting or completing the planned and ongoing trials and the incurrence of unforeseen costs as a result of disruptions in clinical supply or preclinical study or clinical trial delays. The impact of COVID-19 on future results will largely depend on future developments, which are highly uncertain and cannot be predicted with confidence.

    About Fusion

    Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Employing a proprietary Fast-Clear linker technology, Fusion connects alpha particle emitting isotopes to antibodies and other targeting molecules in order to selectively deliver the alpha emitting payloads to tumors. Fusion's lead program, FPI-1434, is currently in a Phase 1 clinical trial.

    Forward-Looking Statements

    Certain statements set forth in this press release constitute "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements can be identified by terms such as "believes," "expects," "plans," "potential," "would" or similar expressions and the negative of those terms. Such forward-looking statements involve substantial risks and uncertainties that could cause Fusion's research and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including Fusions' programs' early stage of development, the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, Fusion's ability to successfully establish, protect and defend its intellectual property, risks relating to business interruptions resulting from the coronavirus (COVID-19) disease outbreak or similar public health crises and other matters that could affect the sufficiency of existing cash to fund operations. Fusion undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the company in general, see Fusion's quarterly report on Form 10-Q for the quarter ended June 30, 2020 which is available on the Securities and Exchange Commission's website at www.sec.gov and Fusions website at www.fusionpharma.com

     

    FUSION PHARMACEUTICALS INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (In thousands, except share amounts)

    (Unaudited)







    September 30,

    2020



    December 31,

    2019

    Assets









    Current assets:









    Cash and cash equivalents



    $                 248,793



    $                   65,344

    Restricted cash



    280



    280

    Short-term investments



    43,159



    Prepaid expenses and other current assets



    4,652



    929

    Total current assets



    296,884



    66,553

    Property and equipment, net



    1,981



    1,272

    Deferred tax assets



    106



    78

    Restricted cash



    1,465



    1,497

    Long-term investments



    11,102



    Other non-current assets



    521



    Total assets



    $                 312,059



    $                   69,400

    Liabilities, Non-Controlling Interest, Convertible Preferred Shares and

       Shareholders' Equity (Deficit)









    Current liabilities:









    Accounts payable



    $                        956



    $                        830

    Accrued expenses



    4,353



    3,326

    Income taxes payable





    117

    Total current liabilities



    5,309



    4,273

    Deferred rent, net of current portion



    3



    28

    Preferred share tranche right liability





    5,741

    Income taxes payable, net of current portion



    293



    293

    Special voting shares redemption right liability (Notes 2 and 7)





    Total liabilities



    5,605



    10,335

    Commitments and contingencies (Note 12)









    Non-controlling interest in Fusion Pharmaceuticals (Ireland) Limited (Notes 2 and 7)





    20,961

    Convertible preferred shares, no par value; 0 shares and 132,207,290 shares

       authorized as of September 30, 2020 and December 31, 2019, respectively; 0 shares

       and 73,125,790 shares issued and outstanding as of September 30, 2020 and December 31,

       2019, respectively; aggregate liquidation preference of $0 and $77,965 as of

       September 30, 2020 and December 31, 2019, respectively





    71,592

    Shareholders' equity (deficit):









    Common shares, no par value, unlimited shares authorized

       as of September 30, 2020 and December 31, 2019; 41,702,384 and 1,929,555 shares issued and

       outstanding as of September 30, 2020 and December 31, 2019, respectively





    Additional paid-in capital



    406,273



    1,286

    Accumulated other comprehensive income



    (1)



    Accumulated deficit



    (99,818)



    (34,774)

    Total shareholders' equity (deficit)



    306,454



    (33,488)

    Total liabilities, non-controlling interest, convertible preferred shares and

       shareholders' equity (deficit)



    $                 312,059



    $                   69,400

     

     

    FUSION PHARMACEUTICALS INC.

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

    (In thousands, except share and per share amounts)

    (Unaudited)







    Three Months Ended

    September 30,



    Nine Months Ended

    September 30,





    2020



    2019



    2020



    2019

    Operating expenses:

















    Research and development



    $           4,529



    $       2,238



    $     12,231



    $       7,216

    General and administrative



    5,790



    1,922



    14,105



    4,864

    Total operating expenses



    10,319



    4,160



    26,336



    12,080

    Loss from operations



    (10,319)



    (4,160)



    (26,336)



    (12,080)

    Other income (expense):

















    Change in fair value of preferred share tranche right liability





    3,485



    (32,722)



    3,707

    Change in fair value of preferred share warrant liability







    (6,399)



    Interest income (expense), net



    80



    247



    249



    395

    Refundable investment tax credits



    41



    44



    139



    132

    Other income (expense), net



    20



    (29)



    148



    76

    Total other income (expense), net



    141



    3,747



    (38,585)



    4,310

    Loss before (provision) benefit for income taxes



    (10,178)



    (413)



    (64,921)



    (7,770)

    Income tax (provision) benefit



    185



    (181)



    (27)



    (213)

    Net loss



    (9,993)



    (594)



    (64,948)



    (7,983)

    Unrealized loss on investments



    (1)





    (1)



    Comprehensive loss



    (9,994)



    (594)



    (64,949)



    (7,983)

    Reconciliation of net loss to net loss attributable to common shareholders:

















    Net loss



    (9,993)



    (594)



    (64,948)



    (7,983)

    Dividends paid to preferred shareholders in the form of

       warrants issued







    (1,382)



    Net loss attributable to common shareholders



    $         (9,993)



    $        (594)



    $   (66,330)



    $     (7,983)

    Net loss per share attributable to common shareholders—basic and

       diluted



    $           (0.24)



    $       (0.31)



    $       (4.30)



    $       (4.18)

    Weighted-average common shares outstanding—basic and diluted



    41,682,797



    1,929,555



    15,422,375



    1,910,695



















     

     

    FUSION PHARMACEUTICALS INC.

    CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

    (In thousands)

    (Unaudited)







    Nine Months Ended September 30,





    2020



    2019

    Cash flows from operating activities:









    Net loss



    $                (64,948)



    $                  (7,983)

    Adjustments to reconcile net loss to net cash used in operating activities:









    Share-based compensation expense



    2,025



    328

    Depreciation and amortization expense



    373



    213

    Non-cash rent expense



    3



    (2)

    Change in fair value of preferred share tranche right liability



    32,722



    (3,707)

    Change in fair value of preferred share warrant liability



    6,399



    Amortization of premiums (accretion of discounts) on investments, net



    24



    Deferred tax benefit



    (28)



    Changes in operating assets and liabilities:









    Prepaid expenses and other current assets



    (3,792)



    16

    Other non-current assets



    (521)



    Accounts payable



    150



    408

    Accrued expenses



    1,025



    719

    Income taxes payable



    (117)



    151

    Net cash used in operating activities



    (26,685)



    (9,857)

    Cash flows from investing activities:









    Purchases of investments



    (54,286)



    Purchases of property and equipment



    (1,063)



    (340)

    Net cash used in investing activities



    (55,349)



    (340)

    Cash flows from financing activities:









    Proceeds from issuance of Class B convertible preferred shares and Class B preferred

       share tranche right, net of issuance costs



    65,676



    45,476

    Proceeds from issuance of Class B preferred exchangeable shares of Fusion

       Pharmaceuticals (Ireland) Limited and Class B preferred share tranche right,

       net of issuance costs



    6,722



    6,711

    Proceeds from the issuance of common shares upon closing of initial public offering, 

         net of underwriter fees



    197,625



    Payment of offering costs



    (4,572)



    Net cash provided by financing activities



    265,451



    52,187

    Net increase in cash, cash equivalents and restricted cash



    183,417



    41,990

    Cash, cash equivalents and restricted cash at beginning of period



    67,121



    29,080

    Cash, cash equivalents and restricted cash at end of period



    $                250,538



    $                  71,070

    Supplemental disclosure of cash flow information:









    Cash paid for income taxes



    $                       280



    $                         40

    Supplemental disclosure of non-cash investing and financing activities:









    Purchases of property and equipment included in accounts payable and accrued expenses



    $                         —



    $                           4

    Issuance of common shares upon net settlement of stock option exercise



    $                         —



    $                         57

    Issuance of warrants to purchase Class B preferred shares and Class B preferred

       exchangeable shares as a non-cash dividend to preferred shareholders



    $                    1,382



    $                         —











     

     

    FUSION PHARMACEUTICALS INC.

    RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL RESULTS

    (In thousands)

    (Unaudited)























    Three Months Ended

    September 30,



    Nine Months Ended

    September 30,





    2020



    2019



    2020



    2019

    GAAP Net loss



    $          (9,993)



    $            (594)



    $      (64,948)



    $        (7,983)

    Less: Adjustments

















    Change in fair value of preferred share tranche right liability





    3,485



    (32,722)



    3,707

    Change in fair value of preferred share warrant liability







    (6,399)



    Non-GAAP Net loss



    $          (9,993)



    $         (4,079)



    $      (25,827)



    $      (11,690)





















     

     

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  27. HAMILTON, ON and BOSTON, Nov. 2, 2020 /PRNewswire/ -- Fusion Pharmaceuticals Inc. (NASDAQ:FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced the appointment of Barbara Duncan, former chief financial officer of Intercept Pharmaceuticals, Inc. and member of several boards of directors within the biotechnology industry, as chairperson of the Fusion Board of Directors. Ms. Duncan brings to the board more than 25 years' experience in the biopharmaceutical industry. She replaces Damian Lamb as Fusion's chairperson.

    "Barbara's breadth and depth of industry, director and financial knowledge will be invaluable to Fusion as we solidify our position as a leader in the radiopharmaceutical space and utilize our Targeted Alpha Therapies (TAT) platform to grow our pipeline," said Chief Executive Officer John Valliant. "Additionally, her leadership experience and strategic approach to business development and corporate governance will provide important organizational and operational guidance." 

    Dr. Valliant continued, "We thank Damian for his years of service on the Board. Over his tenure, his direction and strategic guidance have been instrumental to us as we developed our platform and transitioned from a newly established biotech to a publicly traded company."

    Ms. Duncan most recently served as the chief financial officer of Intercept Pharmaceuticals Inc., a biopharmaceutical company, from 2009 to June 2016. Prior to Intercept, Ms. Duncan served as chief financial officer of DOV Pharmaceutical, Inc., another biopharmaceutical company, from 2001 to 2006 and as its chief executive officer and a member of its board of directors from 2007 to 2009.

    Ms. Duncan currently serves on the boards of directors and various committees of Adaptimmune Therapeutics, plc, Atea Pharmaceuticals, Inc., Jounce Therapeutics, Inc., ObsEva SA and Ovid Therapeutics, Inc., all publicly traded biopharmaceutical companies. Ms. Duncan holds an M.B.A. from the Wharton School of Business and a B.S. from Louisiana State University.

    About Fusion

    Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Employing a proprietary Fast-Clear linker technology, Fusion connects alpha particle emitting isotopes to antibodies and other targeting molecules in order to selectively deliver the alpha emitting payloads to tumors. Fusion's lead program, FPI-1434, is currently in a Phase 1 clinical trial.

     

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  28. Collaboration Combines Fusion's Targeted Alpha Therapies (TATs) Platform with AstraZeneca's Antibody and Oncology Portfolio to Create Novel Cancer Therapies

    Fusion to Host a Conference Call at 8:30am ET

    HAMILTON, ON and BOSTON, Nov. 2, 2020 /PRNewswire/ -- Fusion Pharmaceuticals Inc. (NASDAQ:FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced a collaboration with AstraZeneca (NASDAQ:AZN) to develop and commercialize next-generation alpha-emitting radiopharmaceuticals and combination therapies for the treatment of cancer. 

    The collaboration leverages Fusion's Targeted Alpha Therapies (TATs) platform and expertise in radiopharmaceuticals with AstraZeneca's leading portfolio of antibodies and cancer therapeutics, including DNA Damage Response Inhibitors (DDRis).

    Under the terms of the agreement, the companies will discover, develop and commercialize novel TATs, which will utilize Fusion's Fast-Clear™ linker technology platform with antibodies in AstraZeneca's oncology portfolio. In addition, the companies will  exclusively explore certain specified combination strategies between TATs (including Fusion's lead candidate FPI-1434) and AstraZeneca therapeutics, for the treatment of various cancers. Both companies will retain full rights to their respective assets. 

    "This collaboration represents a true partnership that combines the expertise and intellectual property of each collaborator," said Fusion Pharmaceuticals Chief Executive Officer John Valliant, Ph.D. "The agreement will allow us to leverage Fusion's platform and AstraZeneca's industry-leading antibody portfolio, creating new therapies with shared rights on new TATs, while allowing Fusion to retain full ownership of our existing programs. We are excited about AstraZeneca's long-term commitment to our collaboration, including significant support for exploring combination therapies. We believe it is evidence of the growing interest in the use of molecularly-targeted radiation as a next-generation cancer therapy."

    "Radiopharmaceuticals are a promising area of exploration in oncology, with the potential to deliver radiation therapy selectively to tumors. With this collaboration, we will seek to identify synergies between our pipelines to unlock the full potential of our medicines, and also to develop novel targeted radiopharmaceuticals," said Susan Galbraith, Ph.D., Senior Vice President and Head of Research and Early Development, Oncology R&D, AstraZeneca. "We believe that the Fusion team's expertise in next-generation radiopharmaceuticals complements AstraZeneca's extensive research and development portfolio."

    Collaboration Terms

    The agreement includes an upfront payment from AstraZeneca, as well as future development milestone and other payments.

    Co-Development and Potential Co-Commercialization of Novel TATs

    Under the terms of the agreement, Fusion and AstraZeneca will jointly discover, develop and have the option to co-commercialize novel TATs in the United States.  The novel TATs will leverage Fusion's Fast-Clear linker technology to bind the alpha-emitting isotope Actinium-225 to antibodies in AstraZeneca's oncology portfolio. Fusion will be responsible for preclinical development through first-time-in-human studies, while AstraZeneca will be responsible for subsequent clinical development. For these novel TATs, the companies will share development costs equally through clinical development. Fusion will have co-promotion rights in the United States and AstraZeneca will have commercialization rights in the rest of the world, unless otherwise agreed. Both companies will have a 50/50 profit and loss share on a worldwide basis.

    Development of Combination Therapies with Fusion and AstraZeneca Products

    The companies will also evaluate potential combination strategies involving existing assets in their respective portfolios. Fusion will conduct preclinical development. AstraZeneca will conduct and fund clinical development of the combination therapies.  Each company retains all rights to their respective assets. 

    Fusion Conference Call Information

    Fusion will host a live conference call and webcast today beginning at 8:30 a.m. ET to discuss the collaboration agreement. To access the live call, please dial 1-877-870-4263 (domestic) or 1-412-317-0790 (international) and refer to the Fusion Pharmaceuticals event. A webcast of the conference call will be available under "Events and Presentations" in the Investors & Media section of Fusion's website at https://ir.fusionpharma.com/overview. The archived webcast will be available on Fusion's website shortly after the conclusion and will be available for 90 days following the event.

    About Fusion

    Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Employing a proprietary Fast-Clear linker technology, Fusion connects alpha particle emitting isotopes to antibodies and other targeting molecules in order to selectively deliver the alpha emitting payloads to tumors. Fusion's lead program, FPI-1434, is currently in a Phase 1 clinical trial.

    About AstraZeneca

    AstraZeneca (NASDAQ:AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Twitter @AstraZeneca.

    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 novel Targeted Alpha Therapies or combination therapies for the treatment of various cancers; the likelihood and success of any future clinical trials involving FPI-1434 or any novel Targeted Alpha Therapies or combination therapies for the treatment of various cancers other drug candidates; and the expected benefits of the collaboration agreement with AstraZeneca. 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 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, 2020 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.

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  29. HAMILTON, ON and BOSTON, Sept. 29, 2020 /PRNewswire/ -- Fusion Pharmaceuticals Inc. (NASDAQ:FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced the appointment of Maria Stahl as chief legal officer.

    "Maria brings to Fusion a breadth of legal and operational experience within the biopharmaceutical industry which will be invaluable during this pivotal phase of our company's growth," said Chief Executive Officer John Valliant, Ph.D. "Maria will provide important strategic guidance and legal counsel as we advance our lead candidate and seek to expand our development pipeline. We are excited to welcome her to Fusion's leadership team."  

    Prior to joining Fusion, Ms. Stahl held executive leadership roles at Tetraphase Pharmaceuticals, including chief business officer and general counsel. Before joining Tetraphase, Ms. Stahl was the senior vice president, general counsel of Idenix Pharmaceuticals. Ms. Stahl began her career with the law firm Wilmer Cutler Pickering Hale and Dorr LLP. Ms. Stahl holds a bachelor of arts from Providence College and a juris doctorate from Yale Law School.

    "Fusion has an opportunity to capitalize on a platform technology and deep radiopharmaceutical expertise during a time of significant momentum in the space," said Ms. Stahl. "I am excited to join the team and look forward to working towards our goal to deliver novel cancer therapies to patients."

    About Fusion

    Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Employing a proprietary Fast-Clear linker technology, Fusion connects alpha particle emitting isotopes to antibodies and other targeting molecules in order to selectively deliver the alpha emitting payloads to tumors. Fusion's lead program, FPI-1434, is currently in a Phase 1 clinical trial.

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  30. HAMILTON, ON and BOSTON, Sept. 10, 2020 /PRNewswire/ -- Fusion Pharmaceuticals Inc. (NASDAQ:FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced that the Company will participate in a "fireside chat" presentation at the Morgan Stanley Virtual 18th Annual Global Healthcare Conference on Thursday, September 17, 2020 at 11:00am EDT. Presenting on behalf of Fusion will be Chief Executive Officer John Valliant, Ph.D., Chief Financial Officer John Crowley, and Chief Medical Officer James O'Leary, M.D.

    A live webcast of the event will be available on the "Events and Presentations" page in the "Investors & Media" section of the Company's website at https://ir.fusionpharma.com/events-webcasts. A replay of the webcast will be archived on the Company's website for 90 days following the presentation.  

    About Fusion

    Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Employing a proprietary Fast-Clear linker technology, Fusion connects alpha particle emitting isotopes to antibodies and other targeting molecules in order to selectively deliver the alpha emitting payloads to tumors. Fusion's lead program, FPI-1434, is currently in a Phase 1 clinical trial.

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  31. - Following Fusion's June 2020 initial public offering, cash runway extended into 2024

    HAMILTON, ON and BOSTON, Aug. 11, 2020 /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 second quarter ended June 30, 2020 and provided an update on clinical and corporate developments.

    "By developing targeted alpha therapies (TATs), Fusion is taking a precision medicine approach to radiation therapy," said Chief Executive Officer John Valliant, Ph.D. "In addition to our lead program, FPI-1434, which is currently in a Phase 1 clinical trial, Fusion's research and development capabilities, manufacturing and supply chain expertise, and our Fast-Clear™ linker technology provide a platform for creating new TATs and growing our pipeline."

    Dr. Valliant continued, "Following a successful initial public offering in June, and achieving a regulatory milestone that triggered the second tranche of our Series B financing in May, we are well-positioned to reach significant inflection points in our clinical programs, expand our pipeline, and invest in our platform to create potent TATs."

    "Our near-term priority is to initiate the multi-dosing portion of our Phase 1 trial of FPI-1434, and we are pleased to have received notice from both Health Canada and the U.S. Food and Drug Administration (FDA) that we are able to move forward with these plans," Dr. Valliant concluded.

    Recent Highlights and Future Milestones

    FPI-1434 Monotherapy

    • Fusion has completed enrollment, dosing and the dose-limiting toxicity (DLT) evaluation period for the third patient cohort in the ongoing Phase 1 clinical trial of FPI-1434. Fusion plans to convene a Safety Review Committee (SRC) meeting in the third quarter of 2020 to evaluate the safety of the third patient single-dose cohort of 40kBq/kg (cohort three). Fusion anticipates Phase 1 single-dose safety and imaging data to be available in the fourth quarter of 2020.
    • Fusion received notice from the FDA in May 2020 and a "No Objection Letter" from Health Canada in July 2020 indicating that investigation of the multiple-dose administration in the Phase 1 clinical trial of FPI-1434 may begin.
    • Fusion anticipates reporting Phase 1 multiple-dose safety and imaging data, and the recommended Phase 2 dose/schedule, approximately nine to eighteen months after the commencement of this portion of the study.

    FPI-1434 Combination Therapy

    • Fusion is currently evaluating FPI-1434 in preclinical studies in combination with approved checkpoint and DNA damage response inhibitors, including PARP inhibitors, and believes the synergies observed could expand the addressable patient populations for FPI-1434 and allow for potential use in earlier lines of treatment.
    • Fusion anticipates initiating Phase 1 combination studies six to nine months following determination of the recommended Phase 2 dose of FPI-1434 monotherapy.

    FPI-1966

    • FPI-1966 is designed to target and deliver Actinium to tumor sites expressing FGFR3, a protein that is overexpressed in head and neck and bladder cancers. Following the completion of pre-clinical studies, the Company expects to submit an IND for FPI-1966 approximately six to twelve months after the Company fully resumes preclinical activities following interruptions caused by COVID-19.

    Corporate Updates

    • In June 2020, Fusion completed an initial public offering of 12,500,000 common shares at a public offering price of $17.00 per share. Gross proceeds of the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Fusion, were $212.5 million.
    • In May 2020, upon acceptance of the clinical trial protocol amendment to move from the single- to multiple-dose regimen of FPI-1434, the Company achieved a regulatory milestone associated with the Class B financing which triggered the closing of the second tranche of $62.5 million in gross proceeds.

    Impact of COVID-19

    Fusion is closely monitoring how the spread of COVID-19 is affecting the Company's employees, business, preclinical studies and clinical trials. In response to the COVID-19 pandemic, most employees have transitioned to working remotely and travel has been restricted.

    While Fusion has completed enrollment, dosing and the DLT evaluation period for the third patient cohort in the ongoing Phase 1 clinical trial of FPI-1434, the Company may not be able to enroll additional patient cohorts on the planned timeline due to disruptions at clinical trial sites. Additionally, while certain preclinical activities have restarted, Fusion is currently unable to predict when the Company will fully resume all preclinical activities.

    Although the single dose Phase 1 clinical trial has not been materially affected by the COVID-19 pandemic as of June 30, 2020, at this time, there is significant uncertainty relating to the trajectory of the pandemic. The impact of related responses and disruptions caused by the COVID-19 pandemic may result in difficulties or delays in initiating, enrolling, conducting or completing the planned and ongoing trials and the incurrence of unforeseen costs as a result of disruptions in clinical supply or preclinical study or clinical trial delays. The impact of COVID-19 on future results will largely depend on future developments, which are highly uncertain and cannot be predicted with confidence.

    Second Quarter 2020 Financial Results

    • Cash Position: As of June 30, 2020, Fusion held cash of $318.9 million, compared to cash of $65.3 million as of December 31, 2019. Fusion expects its cash as of June 30, 2020 will enable the Company to fund its operations into 2024.
    • R&D Expenses: Research and development expenses for the second quarter of 2020 were $3.3 million, compared to $2.1 million for the same period in 2019. The increase was primarily due to costs related to our Phase 1 clinical trial of FPI-1434, as well as other development and personnel-related costs.
    • G&A Expenses: General and administrative expenses for the second quarter of 2020 were $4.0 million, compared to $1.8 million for the same period in 2019. The increase was primarily due to an increase in professional fees, personnel-related costs and other costs including general corporate, insurance and facilities costs.
    • Net Loss: For the second quarter of 2020, Fusion reported a net loss of $44.7 million, or $18.91 per share, compared with a net loss of $3.5 million, or $1.79 per share, for the same period in 2019. During the second quarter of 2020, Fusion recorded a non-cash charge of $31.6 million for the final fair value measurement of the Company's Class B preferred share tranche right liability. The fair value increased in the quarter due primarily to an increase in the fair value of the Class B preferred shares as a result of achieving specified milestones underlying the preferred share tranche rights. Fusion also recorded a non-cash charge of $6.1 million during the second quarter of 2020 for the final fair value measurement of the Company's Class B preferred share warrant liability. The fair value increased in the quarter due primarily to an increase in the fair value of the underlying Class B preferred shares resulting from the IPO. The tranche right liability and the warrant liability were reclassified to shareholders' equity during the second quarter of 2020. Excluding these non-cash charges, for the second quarter of 2020 net loss on a non-GAAP adjusted basis was $7.1 million.

    Upcoming Events

    • Fusion will present at the 2020 Wedbush PacGrow Healthcare Virtual Conference on Wednesday, August 12 at 9:10am EDT.
    • Fusion will participate in a virtual "fireside chat" presentation at Morgan Stanley's 18th Annual Global Healthcare Conference on Thursday, September 17 at 11:00am EDT.

    About Fusion

    Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Employing a proprietary Fast-Clear linker technology, Fusion connects alpha particle emitting isotopes to antibodies and other targeting molecules in order to selectively deliver the alpha emitting payloads to tumors. Fusion's lead program, FPI-1434, is currently in a Phase 1 clinical trial.

    Forward-Looking Statements

    Certain statements set forth in this press release constitute "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements can be identified by terms such as "believes," "expects," "plans," "potential," "would" or similar expressions and the negative of those terms. Such forward-looking statements involve substantial risks and uncertainties that could cause Fusion's research and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including Fusions' programs' early stage of development, the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, Fusion's ability to successfully establish, protect and defend its intellectual property, risks relating to business interruptions resulting from the coronavirus (COVID-19) disease outbreak or similar public health crises and other matters that could affect the sufficiency of existing cash to fund operations. Fusion undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the company in general, see Fusion's quarterly report on Form 10-Q for the quarter ended June 30, 2020 which will be available on the Security and Exchange Commission's website at www.sec.gov and Fusions website at www.fusionpharma.com

    FUSION PHARMACEUTICALS INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (In thousands, except share amounts)

    (Unaudited)







    June 30,

    2020





    December 31,

    2019



    Assets

















    Current assets:

















    Cash



    $

    318,892





    $

    65,344



    Restricted cash





    280







    280



    Prepaid expenses and other current assets





    960







    929



    Total current assets





    320,132







    66,553



    Property and equipment, net





    1,403







    1,272



    Deferred tax assets





    78