SEPN — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-08-10

• SEP-631: Oral Small Molecule MRGPRX2 Negative Allosteric Modulator for Mast Cell-Driven Diseases

• We had previously planned to initiate a Phase 2b global, randomized, double-blind, placebo-controlled clinical trial to evaluate safety and exploratory efficacy of SEP-631 in chronic spontaneous urticaria (“CSU”) in the second half of 2026. Based on emerging clinical data in the MRGPRX2 field, in li…

• During the three and six months ended June 30, 2026, we sold 380,172 shares of common stock under the ATM Program at a weighted average price of $36.34 per share, generating net proceeds of $13.8 million. Subsequently, in July 2026, the Company sold an additional 935,730 shares of common stock under…

• We believe our cash, cash equivalents, and marketable securities of $516.5 million as of June 30, 2026 will be sufficient to fund our operations and capital expenditure requirements at least into 2029.

• the U.S. and foreign countries, and military conflicts, such as the ongoing conflicts in Iran, Ukraine and the Middle East. While we believe such factors have had no significant impact on our business or financial results during the periods presented, future developments and potential impacts on our…

Text removed vs the prior filing · source: 10-Q · 2026-05-11

• We believe our cash, cash equivalents, and marketable securities of $522.1 million as of March 31, 2026 will be sufficient to fund our operations and capital expenditure requirements at least into 2029.

• Collaboration, Research Services, and Asset Purchase Agreements

• In May 2025, we entered into a global Collaboration and License Agreement with Novo (the "Novo Collaboration Agreement"). Under the Novo Collaboration Agreement, we and Novo are exclusively collaborating to leverage our proprietary Native Complex Platform® to discover, develop and commercialize mult…

• preclinical studies and other research and development activities on our behalf, costs incurred in connection with laboratory operations, materials and supplies, and other preclinical studies; and

• Research and development expenses were $29.5 million and $19.3 million for the three months ended March 31, 2026 and 2025, respectively. The increase was primarily due to (i) $5.0 million of higher direct costs associated with our clinical, preclinical and research programs, which includes $0.3 mill…

Text added vs the prior filing · source: 10-Q · 2026-08-10

• Since our inception, we have incurred losses and we may never achieve profitability. As of December 31, 2025, we had $45.8 million of federal net operating loss (“NOL”) carryforwards and $77.9 million of state NOL carryforwards, available to reduce future taxable income. To the extent that we contin…

• day-to-day operations of our business and the business of the strategic partner or entity. Furthermore, to the extent that our directors and officers serve on the boards of our strategic partners, such directors may be required to abstain from board decision-making in the event of a conflict of inte…

• Cyberattacks, malicious internet-based activity, online and offline fraud, and other similar activities could result in the theft or destruction of intellectual property, personal data, or other misappropriation of assets, or otherwise threaten to compromise our confidential or proprietary informati…

• to a heightened risk of these attacks, including retaliatory cyber-attacks, that could materially disrupt our systems and operations, supply chain, and ability to produce, sell and distribute our services.

• While we maintain insurance coverage, we cannot assure that such coverage will be adequate or otherwise protect us from or adequately mitigate liabilities or damages with respect to claims, costs, expenses, litigation, fines, penalties, business loss, data loss, regulatory actions or material advers…

Text removed vs the prior filing · source: 10-Q · 2026-05-11

• of our common stock and impair our ability to raise capital, maintain our research and development efforts, expand our business or continue our operations.

• Since our inception, we have incurred losses and we may never achieve profitability. As of December 31, 2025, we had $45.8 million of federal net operating loss (“NOL”) carryforwards and $77.9 million of state NOL carryforwards, available to reduce future

• Cyberattacks, malicious internet-based activity, online and offline fraud, and other similar activities could result in the theft or destruction of intellectual property, personal data, or other misappropriation of assets, or otherwise threaten to compromise our confidential or proprietary informati…

• changing tactics, which may be enhanced or facilitated by artificial intelligence (“AI”). Such threats are increasing in their frequency, sophistication, and intensity, have become increasingly difficult to detect, and come from a variety of sources, including traditional computer “hackers,” threat …

• Portability and Accountability Act of 1996), and foreign (e.g., the GDPR) laws, and may cause a material adverse impact to our reputation, affect our ability to conduct new studies and potentially disrupt our business, results of operations and financial condition.

Text added vs the prior filing · source: 10-Q · 2026-08-10

• During the three months ended June 30, 2026, no directors or officers (as defined in Rule 16a-1(f) of the Exchange Act) of the Company adopted, modified, or terminated a “Rule 10b5-1 trading arrangement” or a “non-Rule 10b5-1 trading arrangement” as each term is defined in Item 408 of Regulation S-K…

Text removed vs the prior filing · source: 10-Q · 2026-05-11

• On March 20, 2026, Daniel Long, D.Phil., our Senior Vice President, Drug Discovery, adopted a pre-arranged trading plan for the sale, at the times and prices specified in the plan, of up to an aggregate of 45,000 shares of our common stock (comprised of shares issuable upon the exercise of option aw…

• During the three months ended March 31, 2026, no other directors or officers (as defined in Rule 16a-1(f) of the Exchange Act) of the Company adopted, modified, or terminated a “Rule 10b5-1 trading arrangement” or a “non-Rule 10b5-1 trading arrangement” as each term is defined in Item 408 of Regulat…