MACROGENICS INC
For the period ended Jun 30, 2026. Filed Aug 14, 2026.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2026 · Filed Aug 14, 2026
MGNX$2.34+0.4%Stored close · as of Nov 9, 2026
What changed in Risk Factors?
Read the current filingPrevious report: 10-Q
Period ended 2026-03-31; filed 2026-05-13.
0001125345-26-000038
Item 1A. Risk FactorsOther InformationCurrent report: 10-Q
Period ended 2026-06-30; filed 2026-08-14.
0001125345-26-000056
Item 1A. Risk FactorsOther InformationThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 27 previous paragraphs and 25 current paragraphs.
6 unchanged; 11 reworded; 8 added; 10 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 2 previous and 2 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
The current filing states there were no material changes to risk factors.
This is the filer’s own statement, not a conclusion from the comparison. Read its qualifications and the report it references.
Current filing’s statement
Our business is subject to risks and events that, if they occur, could adversely affect our financial condition and results of operations and trading price of our securities. In addition to the other information set forth in this Quarterly Report on Form 10-Q, you should carefully consider the factors described in Part I, Item 1A. “Risk Factors” of our Annual Report on Form 10-K for the fiscal year ended December 31, 2025. There have been no material changes in the risk factors described in Item 1A. "Risk Factors” of our Annual Report on Form 10-K for the fiscal year ended December 31, 2025, aside from the risk factors included below:
Added paragraphs (8)
Current report
In addition, as a result of the sale of our CDMO Operations, certain of the risks related to our manufacturing business as reported in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025 are no longer applicable to our business.
Current report
We intend to rely on third parties to conduct a significant portion of our existing clinical trials and potential future clinical trials for product candidates, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials.
Current report
We are in the process of transitioning more of our clinical and development operations to CROs. We expect to rely on these CROs and other third parties, including clinical data management organizations, medical institutions and clinical investigators, to conduct those clinical trials, although we plan to lead the clinical development strategy and intend to play on active role in oversight of CROs and other third parties performing work on our behalf. Any of these third parties may terminate their engagements with us, some in the event of an uncured material breach and some at any time for convenience. If any of our relationships with these third parties terminate, we may not be able to timely enter into arrangements with alternative third parties or to do so on commercially reasonable terms, if at all. Switching or adding CROs involves substantial cost and requires management time and focus.
Current report
In addition, there is a natural transition period when a new CRO commences work. As a result, delays occur, which can materially impact our ability to meet our desired clinical development timelines. Though we intend to carefully manage our relationships with our CROs, there can be no assurance that we will not encounter challenges or delays in the future or that these delays or challenges will not have a material adverse impact on our business, financial condition and prospects. Further, the performance of our CROs may also be interrupted by health epidemics, including due to travel restrictions, quarantine policies, heightened exposure of CRO staff who are healthcare providers to health epidemics or prioritization of resources toward a health epidemic.
Current report
We intend to rely on these parties for execution of our preclinical studies and clinical trials, and generally do not control their activities. Our reliance on these third parties for development activities will reduce our control over these activities but will not relieve us of our responsibilities. For example, we will remain responsible for ensuring that each of our clinical trials is conducted in accordance with the general investigational plan and protocols for the trial. Moreover, the FDA and comparable foreign regulatory authorities require us to comply with standards, commonly referred to as GCPs, for conducting, recording and reporting the results of clinical trials to assure that data and reported results are credible and accurate and that the rights, integrity and confidentiality of trial participants are protected. We also are required to register ongoing clinical trials and post the results of completed clinical trials on government-sponsored databases, such as ClinicalTrials.gov, within specified timeframes. Failure to do so can result in fines, adverse publicity and civil and criminal sanctions. If we or any of our CROs or other third parties, including trial sites, fail to comply with applicable GCPs, the clinical data generated in our clinical trials may be deemed unreliable and the FDA, European Commission or comparable foreign regulatory authorities may require us to perform additional clinical trials before approving our marketing applications. We cannot assure you that upon inspection by a given regulatory authority, such regulatory authority will determine that any of our clinical trials complies with GCP regulations. In addition, our clinical trials must be conducted with product produced under cGMP conditions. Our failure to comply with these regulations may require us to repeat clinical trials, which would delay the regulatory approval process.
Current report
•James Karrels, Senior Vice President and Chief Financial Officer, adopted a new trading plan on June 4, 2026 (with the first trade possible under the new plan no sooner than September 2, 2026). The trading plan will be effective until September 15, 2027 and covers the potential sale of up to 613,207 shares of common stock.
Current report
•Jeffrey Peters, Senior Vice President, General Counsel and Corporate Secretary, adopted a new trading plan on May 20, 2026 (with the first trade possible under the new plan no sooner than August 19, 2026). The trading plan will be effective until August 31, 2027 and covers the potential sale of up to 587,875 shares of common stock.
Current report
•Beth Smith, Vice President, Controller and Treasurer, adopted a new trading plan on June 5, 2026 (with the first trade possible under the new plan no sooner than September 4, 2026). The trading plan will be effective until December 31, 2027 and covers the potential sale of up to 44,000 shares of common stock.
Removed paragraphs (10)
Previous report
In May 2026, we entered into the Asset Purchase Agreement (the “Purchase Agreement”) with Bora Pharmaceuticals Co., Ltd., a company organized under the laws of Taiwan, and Bora Biologics USA, LLC, a Delaware limited liability company (collectively, the “Purchaser”), pursuant to which we agreed to sell to the Purchaser assets and current liabilities related to our GMP manufacturing operations, including our CDMO business (the “CDMO Operations”). In connection with the sale of the CDMO Operations, the Purchaser also intends to extend offers of employment to approximately 140 of our employees currently employed in our manufacturing and related functions.
Previous report
•the impairment of our ability to attract, retain, and motivate key personnel, including our senior management, and particularly those employees to whom employment offers will be extended by the Purchaser;
Previous report
•the inability to pursue alternative business opportunities or make appropriate changes to our business because of requirements in the Purchase Agreement that we conduct our business in the ordinary course and not engage in certain kinds of transactions prior to the completion of the transaction; and
Previous report
The sale of our CDMO Operations may not be completed within the expected timeframe, or at all, and the failure to complete the transaction could adversely affect our business and the market price of our common stock.
Previous report
The completion of the sale of our CDMO Operations is subject to a number of closing conditions as set forth in the Purchase Agreement, including the consent of our landlord to the assignment of the lease of the 9704 Medical Center Drive headquarters, which is the site of our manufacturing operations, and the warehouse operations located at 4735 Arcadia Drive, Frederick, Maryland. We cannot predict when or if these conditions will be satisfied.
Previous report
There can be no assurance that our business, our relationships or our financial condition will not be adversely affected, as compared to the condition prior to the announcement of the transaction, if the transaction is not consummated. Failure to complete the sale of our CDMO Operations could adversely affect our business and the market price of our common stock in a number of ways, including the following:
Previous report
•if the sale of our CDMO Operations is not completed, the share price of our common stock will change to the extent that the current market price of our stock reflects an assumption that the transaction will be completed;
Previous report
•we have incurred, and will continue to incur, significant costs, expenses and fees for professional services and other costs in connection with the sale of the CDMO Operations, including with respect to the transfer of our manufacturing services contracts, for which we may receive little or no benefit if the transaction is not completed. Many of these fees and costs will be payable by us even if the transaction is not completed and may relate to activities that we would not have undertaken other than to complete the transaction; and
Previous report
•a failed sale of our CDMO Operations may result in negative publicity and a negative impression of us in the investment community.
Previous report
The transaction may also be subject to additional governmental reviews, approvals or clearances. Any such review, approval process or clearance could delay the consummation of the transaction, require the parties to agree to conditions or mitigation measures that increase costs or limit the anticipated benefits of the transaction, or result in the inability of the parties to complete the transaction on the anticipated terms or at all..
Reworded paragraphs (11)
Previous wording
We may not realize the expected benefits from the sale of our CDMO Operations.
Current wording
We may not realize the expected benefits from the completed sale of our CDMO Operations.
Previous wording
We may not be able to achieve the full strategic and financial benefits expected to result from the sale of our CDMO Operations, or such benefits may be delayed or not occur at all. In particular, we have made the strategic decision to dispose of our manufacturing facilities and related assets in order to focus on the advancement of our core business, the clinical and preclinical pipeline. Following the closing of the transaction, we will no longer operate our own GMP manufacturing facility and must rely on third parties, including the Purchaser for the clinical and, if approved, commercial manufacture of our product candidates. Although upon closing, we intend to enter into an agreement with the Purchaser for manufacturing services, we have not yet executed such agreement and may not realize the anticipated cost savings associated with contracting out our manufacturing requirements. The assumptions we made related to the sale of our CDMO Operations may prove to be inaccurate, including as to the expected benefits of the transaction and anticipated cost savings. Further, the transition activities following closing may disrupt our operations and divert management’s attention from our business. Moreover, the base purchase price of $122.5 million is subject to certain customary adjustments, including for working capital and indebtedness as set forth in the Purchase Agreement, which may result in lower net proceeds than we anticipate. An inability to realize the anticipated benefits of the transaction could have an adverse impact on our business, financial condition and results of operations.
Current wording
In May 2026, we entered into the Bora Agreement, pursuant to which we agreed to sell to Bora the CDMO Operations. Effective as of June 30, 2026, the sale of the CDMO Operations was completed. At closing, Bora paid us $119.6 million, net of customary post-closing adjustments, and Bora assumed responsibility for the CDMO Operations. In connection with the sale of the CDMO Operations, Bora extended offers of employment to approximately 140 of our employees previously employed in our manufacturing and related functions. We may not be able to achieve the full strategic and financial benefits expected to result from the sale of our CDMO Operations, or such benefits may be delayed or not occur at all. In particular, we have made the strategic decision to dispose of our manufacturing facilities and related assets in order to focus on the advancement of our core business, the clinical and preclinical pipeline. Following the closing of the transaction, we no longer operate our own GMP manufacturing facility and must rely on third parties, including Bora, for the clinical and, if approved, commercial manufacture of our product candidates. Although at closing, we entered into an agreement with Bora for manufacturing services, we may not realize the anticipated cost savings associated with contracting out our manufacturing requirements. The assumptions we made related to the sale of our CDMO Operations may prove to be inaccurate, including as to the expected benefits of the transaction and anticipated cost savings. Further, the ongoing post-closing transition activities may disrupt our operations and divert management’s attention from our business. An inability to realize the anticipated benefits of the transaction could have an adverse impact on our business, financial condition and results of operations.
Previous wording
If the sale of the CDMO Operations is consummated, the Purchase Agreement provides that the Purchaser will assume certain liabilities related to the CDMO Operations and that we will retain certain excluded assets and excluded liabilities. However, notwithstanding the consummation of the transaction, we may remain responsible for, and may be required to satisfy, certain liabilities and obligations, including liabilities that are retained by us under the Purchase Agreement, liabilities that are not effectively assumed by the Purchaser, liabilities that arise out of or relate to our ownership and operation of the CDMO Operations and related facilities prior to closing, and liabilities that are not discovered, asserted or quantified until after closing. These liabilities and obligations could include, among other things, liabilities related to employee matters, taxes, environmental health and safety matters, product quality matters, regulatory compliance, and claims by customers, suppliers, counterparties or other third parties (including claims alleging breaches of contract or tort or other claims arising from pre-closing conduct of the CDMO Operations). In addition, the Purchase Agreement may require us to indemnify the Purchaser for certain matters, and disputes may arise between us and the Purchaser regarding whether a particular liability is an assumed liability or a retained liability, the scope of any indemnification obligations, or the allocation of responsibility for certain claims.
Current wording
Under the Bora Agreement, Bora has assumed certain liabilities related to the CDMO Operations and we have retained certain excluded assets and excluded liabilities. Notwithstanding the consummation of the transaction, we may remain responsible for, and may be required to satisfy, certain liabilities and obligations, including liabilities that are retained by us under the Bora Agreement, liabilities that are not effectively assumed by Bora, liabilities that arise out of or relate to our ownership and operation of the CDMO Operations and related facilities prior to closing, and liabilities that are not discovered, asserted or quantified until after closing. These liabilities and obligations could include, among other things, liabilities related to employee matters, taxes, environmental health and safety matters, product quality matters, regulatory compliance, and claims by customers, suppliers, counterparties or other third parties (including claims alleging breaches of contract or tort or other claims arising from pre-closing conduct of the CDMO Operations). In addition, the Bora Agreement may require us to indemnify Bora for certain matters, and disputes may arise between us and Bora regarding whether a particular liability is an assumed liability or a retained liability, the scope of any potential indemnification obligations, or the allocation of responsibility for certain claims.
Previous wording
The announcement and pendency of the sale of our CDMO Operations could adversely affect our business, financial condition, results and operations.
Current wording
The sale of our CDMO Operations could adversely affect our business, financial condition, results and operations.
Previous wording
The May 2026 announcement and pendency of the closing of the sale of our CDMO Operations could cause disruptions in, and create uncertainty surrounding, our business, which could have an adverse effect on our business, financial condition, results and operations, regardless of whether the transaction is completed. These risks to our business include the following, all of which could be exacerbated by a delay in the completion of the transaction:
Current wording
The sale of our CDMO Operations could cause disruptions in, and create uncertainty surrounding, our business, which could have an adverse effect on our business, financial condition, results and operations. These risks to our business include the following:
Previous wording
•the diversion of significant management time and resources towards the completion of the closing of the transaction;
Current wording
•the diversion of significant management time and resources towards the ongoing post-closing transition activities; and
Previous wording
•litigation relating to the transaction and the costs and distractions related thereto, which could impact our ability to close the transaction within the expected timeframe, or at all.
Current wording
•litigation or disputes relating to the transaction and the costs and distractions related thereto.
Previous wording
Following the closing of the sale of our CDMO Operations, we will no longer operate our own cGMP manufacturing facility and instead will rely on third parties, including the Purchaser, for the clinical and, if approved, commercial manufacture of our product candidates. The third-party manufacturing facilities on which we rely may have limited capacity or fail to meet the applicable stringent regulatory requirements.
Current wording
Following the sale of our CDMO Operations, we no longer operate our own cGMP manufacturing facility and instead must rely on third parties, including Bora, for process development and the clinical and, if approved, commercial manufacture of our product candidates. The third-party manufacturing facilities on which we rely may have limited capacity or fail to meet the applicable stringent regulatory requirements.
Previous wording
Upon the completion of the sale of our CDMO Operations, we will not have any proprietary cGMP manufacturing facilities owned or operated by us. We instead will rely on third parties, including Purchaser, for the cGMP manufacture of our product candidates for clinical development and, if approved, commercial supply. We intend to enter into a long-term manufacturing and supply agreement with the Purchaser in connection with the closing of the transaction; however, we have not yet executed such agreement. There is no guarantee that we will or have properly estimated our required manufacturing capacities or that the third parties we rely on to provide required machinery and materials for the manufacturing process, including the Purchaser, will be able to perform on our proposed timelines or meet our manufacturing demands, if at all. Also, if we must increase production capacity for any reason, we may need to make considerable investments that could lead to significant financing needs or require us to enter into subcontracting agreements in order to outsource part of the production.
Current wording
Following the sale of our CDMO Operations, we do not have any proprietary cGMP manufacturing facilities owned or operated by us. We instead must rely on third parties, including Bora, for CDMO related activities, including the cGMP manufacture of our product candidates for clinical development and, if approved, commercial supply. We have entered into a long-term manufacturing and supply agreement with Bora in connection with the closing of the transaction, pursuant to which we may reserve manufacturing slots. There is no guarantee that we have properly estimated our required process development and manufacturing capacities or that the third parties we rely on to provide required machinery and materials for the manufacturing process, including Bora, will be able to perform on our proposed timelines or meet our demands, if at all. Also, if we must increase production capacity for any reason, our third-party partners, including Bora, may not be able to fulfill our additional capacity needs on our proposed timelines, or we may need to make considerable investments that could lead to significant financing needs or require us to enter into subcontracting agreements in order to outsource part of the production. Transitioning to an alternative contract development and manufacturing organization could require significant time and expense, require regulatory approvals, and result in delays to our clinical trials or commercial supply, any of which could have a material adverse effect on our business, financial condition and results of operations.
Previous wording
If the Purchaser or any other third-party contract manufacturing organization on which we rely experiences capacity constraints, other disruptions, or delays in manufacturing our product candidates, our planned clinical trials and necessary manufacturing capabilities will be disrupted or delayed. Third-party manufacturers may not be able to meet our needs concerning timing, quantity, or quality. If we are unable to contract for a sufficient supply of needed materials on acceptable terms, or if we should encounter delays or difficulties in our relationships with manufacturers, our clinical trials may be delayed, thereby delaying the submission of product candidates for regulatory approval or the market introduction and subsequent sales of any approved products. Any such delay may lower our revenues and potential profitability. If any third party breaches or terminates its agreement with us or fails to conduct its activities in a timely manner, the commercialization of our product candidates could be slowed down or blocked completely. It is possible that third parties relied upon by us will change their strategic focus, pursue alternative technologies, or develop alternative product candidates, either on their own or in collaboration with others, as a means for developing treatments for the diseases targeted by our collaborative programs, or for other reasons. The effectiveness of these third parties in marketing their own products may also affect our revenues and earnings. We intend to continue to enter into additional third-party agreements in the future. However, we may not be able to negotiate any additional agreements successfully. Even if established, these relationships may not be scientifically or commercially successful.
Current wording
If Bora or any other third-party contract manufacturing organization on which we rely experiences capacity constraints, other disruptions, or delays in manufacturing our product candidates, our planned clinical trials and necessary manufacturing capabilities will be disrupted or delayed. Third-party manufacturers may not be able to meet our needs concerning timing, quantity, or quality. If we are unable to contract for a sufficient supply of needed materials on acceptable terms, or if we should encounter delays or difficulties in our relationships with manufacturers, our clinical trials may be delayed, thereby delaying the submission of product candidates for regulatory approval or the market introduction and subsequent sales of any approved products. Any such delay may lower our revenues and potential profitability. If any third party breaches or terminates its agreement with us or fails to conduct its activities in a timely manner, the commercialization of our product candidates could be slowed down or blocked completely. It is possible that third parties relied upon by us will change their strategic focus, pursue alternative technologies, or develop alternative product candidates, either on their own or in collaboration with others, as a means for developing treatments for the diseases targeted by our collaborative programs, or for other reasons. The effectiveness of these third parties in marketing their own products may also affect our revenues and earnings. We intend to continue to enter into additional third-party agreements in the future. However, we may not be able to negotiate any additional agreements successfully. Even if established, these relationships may not be scientifically or commercially successful.
Previous wording
During the three months ended March 31, 2026, none of the Company's directors or officers adopted, modified, orterminated a "Rule 10b5-1 trading arrangement" or "non-Rule 10b5-1 trading arrangement," as each term is defined in Item 408(a) of Regulation S-K.
Current wording
During the three months ended June 30, 2026, the following Section 16 directors or officers adopted, modified, orterminated a "Rule 10b5-1 trading arrangement" or "non-Rule 10b5-1 trading arrangement," as each term is defined in Item 408(a) of Regulation S-K.