ROCKVILLE, MD, May 06, 2025 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (Nasdaq: MGNX), a biopharmaceutical company focused on developing, manufacturing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that the Company will release its financial results for the first quarter of 2025 after the market closes on Tuesday, May 13, 2025.  The Company will not be hosting a conference call to discuss its financial results or corporate progress for the quar ...

Core Viewpoint - MacroGenics (MGNX) has experienced a significant decline of 48.7% over the past four weeks, but it is now positioned for a potential trend reversal as it is in oversold territory, with analysts predicting better earnings than previously expected [1]. Group 1: Technical Indicators - The Relative Strength Index (RSI) is a key technical indicator used to identify oversold stocks, with a reading below 30 typically indicating oversold conditions [2]. - MGNX has an RSI reading of 15.85, suggesting that the heavy selling pressure may be exhausting, indicating a potential bounce back towards equilibrium [5]. Group 2: Fundamental Analysis - There is strong consensus among sell-side analysts that earnings estimates for MGNX have increased by 10.2% over the last 30 days, which often correlates with price appreciation [7]. - MGNX holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises, further supporting the potential for a turnaround [8].

MacroGenics (MGNX) reported $19.35 million in revenue for the quarter ended December 2024, representing a year-over-year increase of 80.5%. EPS of -$0.25 for the same period compares to -$0.75 a year ago.The reported revenue compares to the Zacks Consensus Estimate of $45.26 million, representing a surprise of -57.24%. The company delivered an EPS surprise of -8.70%, with the consensus EPS estimate being -$0.23.While investors scrutinize revenue and earnings changes year-over-year and how they compare with ...

Financial Performance - MacroGenics reported a quarterly loss of $0.25 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.23, but an improvement from a loss of $0.75 per share a year ago [1] - The company posted revenues of $19.35 million for the quarter ended December 2024, missing the Zacks Consensus Estimate by 57.24%, compared to revenues of $10.72 million a year ago [2] - Over the last four quarters, MacroGenics has surpassed consensus EPS estimates only once [2] Stock Performance - MacroGenics shares have declined approximately 32.9% since the beginning of the year, while the S&P 500 has decreased by 3.5% [3] - The current Zacks Rank for MacroGenics is 3 (Hold), indicating that the shares are expected to perform in line with the market in the near future [6] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is -$0.70 on revenues of $21.5 million, and for the current fiscal year, it is -$2.46 on revenues of $91.14 million [7] - The estimate revisions trend for MacroGenics is mixed, and future stock movements will depend on management's commentary during the earnings call [3][4] Industry Context - The Medical - Products industry, to which MacroGenics belongs, is currently ranked in the bottom 49% of over 250 Zacks industries, which may impact the stock's performance [8] - Another company in the same industry, Abbott, is expected to report quarterly earnings of $1.07 per share, reflecting a year-over-year change of +9.2% [9]

MacroGenics (MGNX) Q4 2024 Earnings Call March 21, 2025 03:12 AM ET Company Participants James Karrels - Senior VP, CFO & Corporate SecretaryScott Koenig - President and CEOStephen Eck - Senior VP of Clinical Development & Chief Medical OfficerJonathan Chang - Senior Managing DirectorNick Lorusso - Vice PresidentJonathan Miller - Managing DirectorSilvan Türkcan - Managing DirectorMayank Mamtani - Senior Managing Director Conference Call Participants Peter Lawson - AnalystStephen Willey - Analyst Operator Go ...

Financial Data and Key Metrics Changes - MacroGenics reported total revenue of $150 million for the year ended December 31, 2024, compared to $58.7 million for the year ended December 31, 2023, representing a significant increase primarily due to a net increase of $85 million in revenue recognized from milestones achieved under the Incyte License Agreement [24][25] - Research and development expenses were $177.2 million for the year ending December 31, 2024, compared to $166.6 million for the year ending December 31, 2023, reflecting increased costs related to MGC028 and lorigerlimab [25][26] - The net loss was $67 million for the year ended December 31, 2024, compared to a net loss of $9.1 million for the year ended December 31, 2023 [27] - Cash, cash equivalents, and marketable securities balance as of December 31, 2024, was $201.7 million, down from $229.8 million as of December 31, 2023, with an anticipated cash runway extending into the second half of 2026 [27][28] Business Line Data and Key Metrics Changes - Revenue from collaborative and other agreements was $118.9 million, with net sales contributing $16.4 million and contract manufacturing revenue at $13.1 million for the year ended December 31, 2024 [25] - The company plans to initiate the LINNET Phase 2 study for lorigerlimab, targeting unmet needs in platinum-resistant ovarian cancer and clear cell gynecologic cancer, with enrollment expected to commence by mid-2025 [11][12] Market Data and Key Metrics Changes - The ongoing LORIKEET Phase 2 trial for lorigerlimab has completed enrollment, with a primary endpoint of radiographic progression-free survival (rPFS) [10] - The TAMARACK Phase 2 study results for vobramitamab duocarmazine (vobra duo) showed a median rPFS of 9.5 months for the 2.0 mg/kg cohort and 10.0 months for the 2.7 mg/kg cohort in patients with metastatic castration-resistant prostate cancer (mCRPC) [21][22] Company Strategy and Development Direction - MacroGenics aims to advance its diverse clinical portfolio, focusing on antibody-based cancer treatments, with significant milestones achieved in 2024 and plans for continued progress in 2025 [7][29] - The company is exploring potential alternatives for partnering the vobra duo program while continuing to develop the anti-B7-H3 ADC MGC026 [22][31] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the company's innovative pipeline and the potential for lorigerlimab in previously untreated areas of ovarian cancer and clear cell gynecologic cancers [42][44] - The board is actively searching for a successor to the CEO, with a commitment to support the company during the transition [31] Other Important Information - The company completed the sale of MARGENZA to TerSera Therapeutics in the fourth quarter, providing non-dilutive capital to support clinical pipeline investments [31] - The anticipated funding requirements reflect expected expenditures related to ongoing clinical studies, including the LORIKEET study [28] Q&A Session Summary Question: What are the gating factors to starting the LINNET study? - Management indicated that the standard-of-care for later-line ovarian cancer is low, with overall response rates of 10% to 15% for anti-PD-1 therapies, and they are optimistic about the potential of lorigerlimab in this setting [35] Question: Can you discuss the rationale behind developing lorigerlimab in ovarian and clear cell gynecologic cancers? - The management highlighted that lorigerlimab targets T-cells in the tumor microenvironment, which may lead to better outcomes compared to existing checkpoint inhibitors [42][44] Question: How does the rPFS data for vobra duo clarify the path forward for MGC026? - Management noted that MGC026 is different from vobra duo, with a different linker and payload, and they believe it has the potential for activity beyond what was observed with vobra duo [49][50] Question: What are the expectations for the discontinuation rate in the LORIKEET study? - Management expects better tolerability with lorigerlimab compared to prior checkpoint inhibitors, anticipating a lower discontinuation rate [82] Question: How far along is the Phase 1 study for MGC028? - The Phase 1 study for MGC028 has just begun, and while they are not pre-selecting patients based on ADAM9 expression, they are focusing on tumor types known for upregulation [87][88]

Funding and Collaborations - MacroGenics has received over $1.4 billion in non-dilutive funding since its inception in 2000 through strategic collaborations with global biopharmaceutical companies[23]. - The company has entered into collaborations that provide significant non-dilutive funding and rights to royalties upon achieving development milestones[74]. - Gilead paid MacroGenics a non-refundable upfront payment of $60.0 million under the Gilead Agreement for the development of MGD024, with potential total payments of up to $1.7 billion in fees and milestones[55]. - MacroGenics entered into an agreement with TerSera Therapeutics for the global rights to MARGENZA®, receiving $40.0 million upfront and potential sales milestone payments of up to $35.0 million[43]. - The company has entered into agreements with Incyte and Emergent BioSolutions for contract manufacturing services, receiving upfront payments and annual fixed payments totaling $14.4 million and $9.1 million respectively[60][61]. Clinical Development and Product Candidates - The company is advancing three proprietary product candidates in clinical development: lorigerlimab, MGC026, and MGC028, with lorigerlimab currently in a Phase 2 study expected to commence by mid-2025[24][26]. - The LORIKEET study for lorigerlimab has enrolled 150 patients, with the primary endpoint being radiographic progression-free survival (rPFS)[28]. - MGC026 is in a Phase 1 dose escalation study, with plans to initiate dose expansion in selected indications in 2025[31]. - MGC028 has shown specific, dose-dependent in vivo antitumor activity in preclinical studies across multiple cancer types[34]. - MacroGenics continues to enroll patients in a Phase 1 study of MGD024 for CD123-positive neoplasms, including acute myeloid leukemia[53]. - The company is currently enrolling patients in clinical trials for multiple product candidates, including lorigerlimab and retifanlimab[168]. Safety and Efficacy Concerns - The TAMARACK study for vobramitamab duocarmazine reported an aggregate of 11 treatment-related deaths (6.1%) among 180 patients treated[38]. - The company has decided not to pursue further internal development of vobramitamab duocarmazine due to its safety and efficacy profile[40]. - The company announced the discontinuation of its Phase 2 trial of enoblituzumab due to safety data concerns, with 11 treatment-related deaths reported (6.1% of 180 patients) in the TAMARACK study[182]. Manufacturing and Facilities - MacroGenics operates a 5 × 2,000 liter commercial-scale cGMP antibody manufacturing facility to support clinical programs and provide outsourced services[23]. - Manufacturing is conducted at the company's facility in Rockville, Maryland, with reliance on contract manufacturers for ADC components[86]. - The company has limited experience in large-scale commercial manufacturing, which may lead to production difficulties and supply disruptions[190]. Regulatory and Compliance Issues - The FDA has a 60-day period to determine if a BLA is accepted for filing, with a standard review period of 10 months for non-priority BLAs[108]. - The company is required to submit periodic reports and adverse event reports following FDA approval of a Biologics License Application (BLA)[119]. - The company must comply with the Drug Supply Chain Security Act, which regulates drug distributors[121]. - The company is subject to various federal and state laws related to healthcare fraud and abuse, which may lead to significant penalties for noncompliance[123]. - Regulatory compliance is critical, as failure to meet FDA requirements could result in sanctions and hinder product commercialization[210]. Financial Performance and Projections - As of December 31, 2024, the company's accumulated deficit was approximately $1.2 billion, and it anticipates continuing to incur losses for the foreseeable future[155]. - The company expects its cash, cash equivalents, and marketable securities, combined with anticipated collaboration payments, should enable it to fund operations into the second half of 2026[151]. - The company will require substantial additional funding to complete the development and commercialization of its product candidates, which may not be available on acceptable terms due to current economic conditions[151]. - The company has federal and state net operating loss (NOL) carryforwards of approximately $554.0 million and federal research and development tax credits of approximately $109.0 million available[160]. - The company is subject to Section 382 limitations due to acquisitions made in 2002 and 2008, which may further restrict the utilization of NOL carryforwards and tax credits[160]. Competitive Landscape - The competitive landscape includes numerous companies developing treatments for cancer, utilizing both small molecule drugs and biologic therapeutics[92]. - The company faces significant competition from major pharmaceutical companies with greater resources, which may impact its commercial opportunities[185]. - Competitors are also developing therapeutics targeting multiple specificities using single recombinant molecules, including Amgen and BioNTech, which may impact the company's market position[95]. - The company faces competition in the CDMO service market from full-service contract manufacturers and large pharmaceutical companies, which have greater financial and technical resources[96]. - Mergers and acquisitions in the pharmaceutical and biotechnology industries may further concentrate resources among competitors, increasing competitive pressure[97]. Employee and Organizational Aspects - The company had 341 full-time employees as of December 31, 2024, with 273 engaged in research, development, and manufacturing activities[136]. - The company emphasizes competitive employee wages and links annual compensation changes to overall company performance[138]. - The company maintains an Employee Stock Purchase Plan allowing employees to purchase stock at 85% of fair market value[139]. - 95% of the workforce participated in the employee engagement survey conducted in 2024[142]. - The company invests in employee learning and development, providing resources for leadership and technical skill training[144]. Market and Pricing Challenges - The company anticipates pricing pressures due to managed healthcare trends and evolving payor models, which may affect product sales[198]. - Reimbursement decisions by third-party payors significantly impact market acceptance and pricing of the company's products[199]. - There is uncertainty regarding coverage and reimbursement for newly approved products, as decisions are primarily made by CMS[200]. - The lack of uniform reimbursement policies in the U.S. can lead to significant delays and costs in obtaining coverage for products[201]. - Health reform actions may exert downward pressure on pharmaceutical pricing, potentially affecting revenue and competitiveness[202]. Risks and Uncertainties - The company may experience delays in clinical trials or regulatory approvals, which could increase costs and delay commercialization of its product candidates[149]. - The company may face adverse effects from economic downturns, inflation, and geopolitical events, which could negatively impact its financial performance[158]. - Raising additional capital may cause dilution to stockholders and restrict the company's operations or require relinquishing substantial rights[159]. - The company depends substantially on the successful clinical development of its product candidates, with significant investment in their development[161]. - Clinical drug development is lengthy and expensive, with uncertain outcomes, potentially leading to significant additional costs and delays[163].

Core Insights - MacroGenics, Inc. has achieved multiple clinical development milestones in 2024, including the completion of enrollment in the LORIKEET Phase 2 study for lorigerlimab in combination with docetaxel for mCRPC patients [2][5] - The company has decided to discontinue further internal development of vobra duo based on the results of the TAMARACK Phase 2 study, while expressing optimism about the potential of the B7-H3 target and the progress of MGC026 [2][10] Clinical Development Updates - The LORIKEET Phase 2 trial is a randomized study involving 150 patients, evaluating lorigerlimab in combination with docetaxel, with clinical updates expected in the second half of 2025 [5][6] - A new LINNET Phase 2 study will evaluate lorigerlimab as monotherapy in patients with platinum-resistant ovarian cancer or clear cell gynecologic cancer, targeting enrollment of up to 60 patients [6] - MGC026, a TOP1i-based ADC targeting B7-H3, is currently in a Phase 1 dose escalation study, with dose expansion expected to begin in 2025 [6][7] - MGC028, another TOP1i-based ADC targeting ADAM9, has shown promising preclinical results and is currently in a Phase 1 study [7] Financial Performance - As of December 31, 2024, MacroGenics reported cash, cash equivalents, and marketable securities of $201.7 million, down from $229.8 million in 2023, with a cash runway projected into the second half of 2026 [5][10] - Total revenue for the year ended December 31, 2024, was $150.0 million, a significant increase from $58.7 million in 2023, primarily due to milestone payments from the Incyte License Agreement [10][18] - Research and development expenses rose to $177.2 million in 2024 from $166.6 million in 2023, driven by increased costs related to MGC028 and lorigerlimab [10][12] - The net loss for 2024 was $67.0 million, compared to a net loss of $9.1 million in 2023 [10][18] Strategic Collaborations and Partnerships - MacroGenics continues to collaborate with Gilead Sciences on MGD024, a next-generation CD123 × CD3 DART molecule, currently in a Phase 1 study [11] - The company has received $365.0 million in upfront and milestone payments from Incyte for the licensed monoclonal antibody retifanlimab, with potential for an additional $540.0 million in future milestones [11] - MARGENZA's global rights were sold to TerSera Therapeutics for an initial payment of $40.0 million, with additional milestone payments possible [11][18]

Core Viewpoint - MacroGenics, Inc. will release its financial results for Q4 and the full year of 2024 on March 20, 2025, after market close, and will host a conference call to discuss these results and recent corporate developments [1]. Group 1: Financial Results Announcement - The financial results for the fourth quarter and full year of 2024 will be announced after market close on March 20, 2025 [1]. - A conference call to discuss the financial results and corporate progress will take place on the same day at 4:30 pm ET [1]. Group 2: Conference Call Information - Participants can register in advance to join the conference call via a provided link, receiving a confirmation email with details on how to join [2]. - A listen-only webcast of the conference call will be available in the Investor Relations section of the company's website [2]. - A recorded replay of the webcast will be accessible shortly after the call and archived for 30 days [2]. Group 3: Company Overview - MacroGenics is a biopharmaceutical company focused on developing monoclonal antibody-based therapeutics for cancer treatment [3]. - The company utilizes proprietary next-generation antibody-based technology platforms to generate its pipeline of product candidates [3]. - MacroGenics has established several strategic collaborations with global pharmaceutical and biotechnology companies [3].

Group 1 - MacroGenics, Inc. (NASDAQ: MGNX) is a biotech company that has been previously analyzed for its potential amidst market overreactions to negative news [1] - The author has a PhD in biochemistry and extensive experience in analyzing clinical trials and biotech companies, emphasizing the importance of understanding the science behind investments [1] Group 2 - No stock or derivative positions are held by the author in any mentioned companies, nor are there plans to initiate such positions in the near future [2] - The article reflects the author's personal opinions and is not influenced by any business relationships with the companies discussed [2]