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Xencor(XNCR) - 2021 Q2 - Quarterly Report
2021-08-04 21:23
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2021 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to ________ Commission file number: 001-36182 Xencor, Inc. (Exact name of registrant as specified in its charter) Delaware 20-162250 ...
Xencor (XNCR) Investor Presentation - Slideshow
2021-05-21 19:46
| --- | --- | --- | --- | --- | |-------|----------------------------------|-------|-------|-------| | | | | | | | | Proteins by Design | ® | | | | | Antibody & Cytokine Therapeutics | | | | Forward-Looking Statements Certain statements contained in this presentation, other than statements of historical fact, may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements regarding Xencor's deve ...
Xencor(XNCR) - 2021 Q1 - Earnings Call Transcript
2021-05-08 22:42
Xencor, Inc. (NASDAQ:XNCR) Q1 2021 Results Conference Call May 5, 2021 4:30 PM ET Company Participants Charles Liles - Head of Investor Relations Bassil Dahiyat - President and Chief Executive Officer Allen Yang - Chief Medical Officer John Kuch - Chief Financial Officer John Desjarlais - Chief Scientific Officer Conference Call Participants Ted Tenthoff - Piper Sandler Mara Goldstein - Mizuho Securities Peter Lawson - Barclays Li Wang Watsek - Cantor Etzer Darout - Guggenheim Tom Shrader - BTIG Zhiqiang Sh ...
Xencor(XNCR) - 2021 Q1 - Quarterly Report
2021-05-05 21:26
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2021 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to ________ Commission file number: 001-36182 Xencor, Inc. (Exact name of registrant as specified in its charter) Delaware 20-16225 ...
Xencor(XNCR) - 2020 Q4 - Earnings Call Transcript
2021-02-24 05:21
Financial Data and Key Metrics Changes - Total revenues on a GAAP basis for the year ended December 31, 2020, were $122.7 million, compared to $156.7 million for the same period in 2019, reflecting a decrease due to lower collaboration and licensing revenue [46] - Total research and development expenses in 2020 were $169.8 million, an increase from $118.6 million in 2019, primarily due to increased spending on bispecific antibody and cytokine candidate technologies [47] - The net loss for the year was $13.7 million or $0.24 on a fully diluted per share basis, compared to net income of $26.9 million or $0.46 on a fully diluted share basis for 2019 [49] Business Line Data and Key Metrics Changes - The company is focusing on the expansion of its XmAb bispecific platform, currently running six Phase I clinical studies evaluating such antibodies [9] - The partnership with Genentech for XmAb306 initiated dose escalation in combination with atezolizumab, highlighting the collaborative approach to clinical development [15] - The company reported no significant COVID-19 disruptions to operations during the last quarter, indicating stable operational performance [16] Market Data and Key Metrics Changes - The company ended the year with cash, cash equivalents, and marketable securities totaling $604 million, compared to $601.3 million at the end of 2019, indicating stable financial health [45] - The company expects to end 2021 with between $425 million and $475 million in cash and cash equivalents, reflecting a strong cash position to support ongoing R&D [45] Company Strategy and Development Direction - The company aims to grow its pipeline with new programs and is focused on advancing candidates based on data-driven decisions, allowing for outlicensing or termination of non-core assets [66] - The strategy includes leveraging partnerships to enhance clinical development and expand the use of XmAb technology, with 13 ongoing partnerships resulting in two marketed products to date [36][39] - The collaboration with MD Anderson Cancer Center aims to execute additional clinical studies and generate new clinical insights across the oncology portfolio [41] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the early data from XmAb717 in prostate cancer and plans to initiate a Phase 1b study for patients with certain molecular subtypes [25] - The management team emphasized the importance of adapting to the pandemic's challenges, noting that enrollment in clinical trials has not been significantly affected [78] - The company is optimistic about the potential of its bispecific antibody programs and the strategic partnerships that enhance its clinical development capabilities [66] Other Important Information - The company has renamed its programs for clarity, shortening names to the final three digits [7] - The company is actively pursuing new partnerships to expand its pipeline and enhance clinical development programs [38] Q&A Session Summary Question: What will be presented at AACR this year? - Management indicated that they cannot disclose specific presentations until abstracts are published, but they plan to highlight both preclinical progress and clinical programs [53] Question: Can you provide more details on the molecular subtypes in the CRPC study? - Management stated that details will be shared once the trial is up and running, emphasizing the importance of understanding the patient demographics and populations involved [59] Question: What is the status of the collaboration with Roche? - The collaboration involves a 55:45 P&L split, with shared clinical development costs and decision-making, but specific data cannot be disclosed until a publication plan is agreed upon [72] Question: When can we expect additional clinical data for plamotamab? - Management expects to have more plamotamab data later this year, with updates anticipated at a medical conference [85] Question: How does the company view its position relative to other emerging technologies? - Management expressed confidence in their avidity approach, noting its proven effectiveness in antibody engineering compared to newer technologies [111]
Xencor(XNCR) - 2020 Q4 - Annual Report
2021-02-24 01:20
Drug Development and Clinical Trials - The company has developed two marketed drugs using its XmAb technologies, including Monjuvi® and Ultomiris®, which enhance therapeutic properties through engineered Fc domains[15][16]. - The company is advancing multiple drug candidates into clinical development, with seven candidates currently in Phase 1 studies targeting various cancers and one for autoimmune diseases expected to start Phase 1 in early 2021[23]. - The company is conducting Phase 1 studies for three TME activator candidates designed to promote tumor-selective T-cell activation[30]. - XmAb717 achieved an objective response rate of 19.0% (8/42) across multiple tumor types, with a complete response in one melanoma patient and partial responses in several others[39]. - In the Phase 1 study of vibecotamab, the overall response rate was 15% (8/54), with an increase to 26% (7/27) in patients with low disease burden[42]. - Tidutamab demonstrated a disease control rate of 43% and a median treatment duration of approximately seven months in patients with neuroendocrine tumors[43]. - The company plans to initiate a Phase 1 study for XmAb564, an IL-2-Fc fusion candidate for autoimmune diseases, after receiving FDA IND approval in January 2021[32]. - The Phase 1 study of AMG 509, a bispecific antibody for prostate cancer, is currently enrolling patients[50]. - The company has a diversified portfolio with 20 drug candidates in clinical development, including 10 candidates engineered with its bispecific Fc domain[34][36]. - The company has successfully completed clinical trials with subcutaneous formulations for obexelimab, manufactured by third-party contract manufacturers[118]. Strategic Collaborations and Partnerships - The company has entered into strategic collaborations with Atreca, Inc. and MD Anderson Cancer Center to create novel CD3 bispecific antibody drug candidates and support Investigator Sponsored Trials[21][22]. - The company retains major economic interests in its drug candidates through strategic partnerships, allowing for profit-sharing and co-development options[55]. - Genentech has a worldwide exclusive license for XmAb306, with the company maintaining rights for independent clinical studies[57]. - The company is conducting a two-year joint research program with Genentech to discover additional IL-15 programs[60]. - Catabasis has entered into strategic collaborations with partners like MorphoSys AG and Atreca, Inc. to develop novel therapeutics and share research costs equally[94][95]. Financial Performance and Projections - In 2020, the company generated $165 million in total proceeds from licensing and collaboration arrangements, including upfront payments, milestone payments, and royalties[20]. - The company incurred a net loss of $69.3 million for the year ended December 31, 2020, with an accumulated deficit of $365.7 million as of the same date[186]. - The company expects to continue incurring significant losses for the foreseeable future as it executes its research and development activities[186]. - The company has not yet generated any revenue from product sales and does not anticipate doing so in the foreseeable future[188]. - The company may require additional financing to complete the clinical development of its product candidates, which may not be available on favorable terms[191]. Market and Competitive Landscape - The estimated medical expenditures for cancer in the U.S. were projected to reach at least $158.0 billion in 2020, highlighting the market opportunity for Catabasis's drug candidates[106]. - The company faces intense competition in the bispecific antibody market, with numerous competitors including Amgen, Genmab, and Regeneron[128]. - The company faces significant competition from other biotechnology and pharmaceutical companies, which could adversely affect its operating results[186]. Regulatory Environment - The regulatory process for drug candidates involves extensive preclinical studies and clinical trials, requiring significant time and financial resources[135][136]. - The FDA requires a Biologics License Application (BLA) for marketing approval, which involves multiple phases of clinical trials[137][141]. - The FDA's standard review process for a Biologics License Application (BLA) is 10 months once accepted, but it can take longer[147]. - The company is subject to ongoing regulation by the FDA, including compliance with current Good Manufacturing Practices (cGMP) and reporting of adverse experiences[150]. - The company must obtain requisite approvals from regulatory authorities in foreign countries prior to commencing clinical trials or marketing its products[158]. Intellectual Property and Patent Portfolio - The company continues to expand its patent portfolio to protect its XmAb technologies and drug candidates[25]. - The company has over 1,000 issued patents and pending patent applications worldwide, covering XmAb Fc domains and clinical and preclinical stage product candidates[109]. - The patent expiration for key technologies includes bispecific candidates expiring in 2034 in the U.S. and 2035 Ex-U.S.[110]. - The company may apply for a patent term extension of up to five years under the Hatch-Waxman Amendments for its biologic product candidates[152]. Employee and Operational Considerations - As of December 31, 2020, Catabasis had 202 full-time employees, representing a 22% increase from the previous year, with 156 engaged in research and development[99]. - The company has implemented various employee support policies, including remote work mandates and additional compensation for onsite employees during the COVID-19 pandemic[103]. - The company maintains a commitment to diversity, with 53% of employees being non-white and 55% women as of December 31, 2020[102]. Stock and Ownership Structure - As of December 31, 2020, executive officers, directors, and 5% stockholders beneficially owned approximately 67% of the company's voting stock, allowing them significant control over stockholder matters[201]. - The concentration of ownership may prevent other stockholders from realizing the true value of the common stock and could discourage unsolicited acquisition proposals[202]. - The company may face substantial dilution for current stockholders if additional capital is raised through equity or convertible debt securities[203]. - Future sales of common stock or rights to purchase common stock could result in additional dilution and potentially cause the stock price to fall[204]. - As of December 31, 2020, the company had options to purchase 7,751,789 shares outstanding under its equity compensation plans[206]. - The company plans to register shares available for issuance under its equity compensation plans, which could lead to further dilution for existing stockholders[207]. Risks and Challenges - The company has incurred significant losses since its inception and anticipates continuing to incur significant losses for the foreseeable future[164]. - The company has not demonstrated its ability to successfully complete pivotal clinical trials or obtain regulatory approvals for its product candidates[173]. - The COVID-19 pandemic has caused delays in clinical trial enrollment and may continue to impact the company's operations and financial condition[178]. - The company relies on third-party manufacturers for the production of its XmAb engineered antibodies, which can lead to delays if any issues arise[166]. - The company relies on third-party vendors for research supplies and has experienced critical supply shortages that could delay development timelines by three to six months[184]. - Effective internal control over financial reporting is necessary to provide reliable financial reports, and failure to maintain such controls could lead to material misstatements[208].
Xencor(XNCR) - 2020 Q3 - Earnings Call Transcript
2020-11-08 15:01
Financial Data and Key Metrics Changes - As of September 30, 2020, cash, cash equivalents, and marketable securities totaled $582.9 million, down from $601.3 million at December 31, 2019, reflecting cash used for operating activities [31] - Total revenue for Q3 2020 was $35.4 million, compared to $21.8 million for the same period in 2019, driven by milestone revenue from MorphoSys and licensing revenue from Omeros [32] - Total revenue for the nine months ended September 30, 2020, was $80.8 million, down from $153.2 million for the same period in 2019, primarily due to higher collaboration licensing revenue in 2019 [33] - Research and development expenditures for Q3 2020 were $44.5 million, up from $29.8 million in Q3 2019, reflecting increased spending on clinical programs [34] - Net loss for Q3 2020 was $12.6 million, or $0.22 per share, compared to a net loss of $10.2 million, or $0.18 per share, for the same period in 2019 [37] - For the nine months ended September 30, 2020, net loss was $55.6 million, or $0.97 per share, compared to net income of $53.8 million, or $0.92 per share, for the same period in 2019 [38] Business Line Data and Key Metrics Changes - The company is currently running six Phase I clinical studies evaluating XmAb bispecific antibodies, with a focus on oncology treatments [9] - The autoimmune IL-2 Fc program, XmAb27564, is on track for a Phase I study initiation in early 2021 [12][23] - The company has 12 ongoing partnerships for XmAb technology, resulting in two marketed products: Alexion's ULTOMIRIS and MorphoSys' Monjuvi [26] Market Data and Key Metrics Changes - The COVID-19 pandemic did not significantly disrupt patient enrollment in ongoing clinical studies, although there were critical shortages of materials affecting manufacturing processes [11] - Partnerships with companies like Genentech and Omeros continue to generate revenue without significant COVID-19 impacts [24] Company Strategy and Development Direction - The company is focusing on expanding its XmAb bispecific platform to create antibodies that bind multiple targets and engineer cytokines optimized for therapeutic use [9] - Partnerships are a core part of the business model, generating payments from licensing XmAb technologies and royalties from approved products [24] - The company is exploring opportunities to develop vibecotamab in patients with lower baseline leukemic disease burden [14] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the ongoing clinical programs and the potential for advancing multiple assets based on emerging proof-of-concept data [89] - The company expects to have sufficient cash to fund R&D programs and operations into 2024, projecting to end 2020 with between $525 million and $575 million in cash [39] Other Important Information - The company is maintaining remote work requirements for non-laboratory employees while ensuring on-site safety measures for those working in labs [12] - The company is developing a suite of cytokines engineered with XmAb bispecific Fc domains to improve their properties and drug-like characteristics [21] Q&A Session Summary Question: Next steps for CD123 for AML - Management indicated that they have restrictions due to the partnership with Novartis but noted that they observed more activity in patients with lower disease burdens [41][44] Question: Bar for AML in this population - Management stated that the populations possible with the agent vary, and they have good ideas about the bar without disclosing specifics [46] Question: Confidence in tolerability of 20717 - Management discussed the design of the molecule, which requires cooperative binding for strong binding, and noted that the tolerability profile is encouraging [50][54] Question: Planned studies for plamotamab - Management confirmed that Phase II studies are planned for relapsed refractory DLBCL, with more details to come [58] Question: Differences in patient characteristics for vibecotamab - Management indicated that there have not been significant changes to inclusion/exclusion criteria, so no major shifts in demographics are expected [72]
Xencor(XNCR) - 2020 Q3 - Quarterly Report
2020-11-05 23:44
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2020 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to ________ Commission file number: 001-36182 Xencor, Inc. (Exact name of registrant as specified in its charter) Delaware 20-1 ...
Xencor(XNCR) - 2020 Q2 - Earnings Call Presentation
2020-08-10 16:49
Antibodies by Design™ XmAb® Antibody Therapeutics Corporate Overview August 2020 Forward-Looking Statements Certain statements contained in this presentation, other than statements of historical fact, may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements regarding Xencor's development plans and timelines; potential regulatory actions; expected use of cash resources; the timing and resu ...
Xencor(XNCR) - 2020 Q2 - Earnings Call Transcript
2020-08-05 05:50
Financial Data and Key Metrics Changes - For Q2 2020, revenues were $13.1 million, a decrease from $19.5 million in Q2 2019 [48] - For the first six months of 2020, revenues totaled $45.5 million, down from $131.4 million in the same period in 2019 [49] - The net loss for Q2 2020 was $35 million, or $0.61 per share, compared to a net loss of $16 million, or $0.28 per share in Q2 2019 [53] - For the first six months of 2020, the net loss was $43.1 million, or $0.76 per share, compared to net income of $64 million, or $1.10 per share in the same period in 2019 [54] - Cash and cash equivalents as of June 30, 2020, totaled $587.4 million, down from $601.3 million at the end of 2019 [47] Business Line Data and Key Metrics Changes - Research and development expenditures for Q2 2020 were $43.5 million, up from $33.3 million in Q2 2019 [50] - General and administrative expenses for Q2 2020 were $7.2 million, compared to $5.8 million in Q2 2019 [52] - The increase in R&D spending was primarily due to advancements in clinical programs such as plamotamab and XmAb2717 [51] Market Data and Key Metrics Changes - The company has 11 ongoing partnerships for XmAb technology, resulting in two marketed products and seven clinical stage candidates [15] - The partnership with Alexion's Ultomiris continues to receive marketing authorizations worldwide, with the latest approval for atypical hemolytic uremic syndrome [23] Company Strategy and Development Direction - The company is focusing on expanding its XmAb bispecific platform to create antibodies targeting multiple mechanisms simultaneously [10] - Xencor aims to selectively license access to its XmAb technologies for developing antibodies, emphasizing the importance of partnerships to complement its internal portfolio [22] - The recent FDA approval of MorphoSys's Tafasitamab, a product developed under Xencor's technology, highlights the potential of its platform [17] Management's Comments on Operating Environment and Future Outlook - Management noted that the COVID-19 pandemic did not significantly disrupt patient enrollment in ongoing clinical trials, although some trial initiations were delayed [11] - The company expects to have sufficient cash to fund operations into 2024, projecting a year-end cash balance between $525 million and $575 million [56] Other Important Information - The company is advancing its pre-clinical programs, including XmAb30819, which targets ENPP3 and is expected to file an IND in 2021 [31] - The collaboration with Atreca aims to develop bispecific antibodies targeting novel tumor antigens, leveraging Atreca's discovery platform [33] Q&A Session Summary Question: Can you provide details on the royalties and future milestones related to Monjuvi? - The royalties are in the high-single to low-double digit range, with significant milestones for development and sales in oncology [61][62] Question: What data can we expect from Tidutamab? - The upcoming data will focus on safety and efficacy in the neuroendocrine tumor population, with a low standard-of-care response rate around 10% [70][71] Question: What is the development strategy for plamotamab? - The company sees promising activity in late-line lymphoma and plans to announce specific trials for combination and monotherapy approaches later this year [84][85] Question: Can you comment on the adverse events observed with AMG 424? - The adverse events were likely CD38 mediated, and the company is assessing potential next steps for the program [89] Question: What is the status of the Atreca collaboration? - The collaboration utilizes existing antibodies from Atreca's screening work, with ongoing discovery activities to replenish the antibody basket [140][141]