SVRA 10-K & 10-Q changes, risk factors and insider trading

The success of our business is dependent on our ability to advance the clinical development of our sole product candidate, MOLBREEVI, an investigational inhaled GM-CSF for the treatment of aPAP.autoimmune PAP. To date, we have never obtained regulatory approvals for or commercialized a product candidate, and we may never be able to develop a marketable product. We are devoting, and expect to continue to devote, substantially all our efforts and financial resources to the development of MOLBREEVI for aPAP,autoimmune PAP, including clinical trials, regulatory approval, and, if approved, commercialization. Our business depends heavily on the successful completion of clinical development and subsequent regulatory approval of MOLBREEVI for aPAP.autoimmune PAP.

We are conducting IMPALA-2, a global Phase 3 pivotal trial designed to compare the efficacy and safety of MOLBREEVI 300 µg administered once daily by inhalation with matching placebo in patients with aPAP.autoimmune PAP. Although we may believe the trial demonstrates promising results, regulatory authorities may analyze or weigh trial data differently, resulting in delay or failure to obtain marketing approval or a requirement to conduct confirmatory studies.

Many of these clinical, regulatory, and commercial matters are beyond our control and are subject to other risks described elsewhere in this Item 1A, Risk Factors section. Accordingly, we cannot assure that we will be able to advance our product candidate further through final clinical development, or obtain regulatory approval of,approval, commercialize, or generate significant revenue. If we cannot do so, or are significantly delayed in doing so, our business will be materially harmed.

delays in reaching agreements on acceptable terms with prospective CMOs or other vendors for the production and supply of clinical trial material and, if necessary, drug administrationdelivery devices, which agreements can be subject to extensive negotiation;

invalidation of clinical data caused by premature unblinding or integrity issues or by mixing up of the active drug and placebo through randomization or manufacturing errors;

delays on the part of ourby CROs, CMOs, and other third-party contractors in developing procedures and protocols or otherwise conducting activities in accordance with applicable policies and procedures and in accordance with agreed upon timelines;

Changes in governmental regulations and guidance relating to clinical trials may occuroccur, and we may need to amend clinical trial protocols to reflect these changes, or we may amend trial protocols for other reasons. Amendments may require us to resubmit protocols to IRBs for re-examination and approval or renegotiate terms with CROs, clinical trial sites, and investigators, all of which may adversely impact the costs or timing of or our ability to successfully complete a trial.

Even if our clinical trials are completed, the results may not be sufficient to obtain regulatory approval for our product candidate. There are significant risks that ongoing and future clinical trials of our product candidate will not be successful. The results of preclinical and early clinical trials may not be predictive of the results of later-stage clinical trials, and the possible lack of standardization across multiple investigative sites may induce variability in the results which can interfere with the evaluation of treatment effects. A number of companies in the pharmaceutical industry have suffered significant setbacks in advanced clinical trials due to lack of efficacy or adverse safety profiles, notwithstanding promising results in earlier clinical trials, and we cannot be certain that we will not face similar setbacks. For example, the top line results from our IMPALA trial were released by us on June 12, 2019 and did not meet all of the statistical goals and protocol end points. On October 1, 2019, we received a written response from the FDA in connection with a Type C meeting regarding the MOLBREEVI development program for aPAPautoimmune PAP and results from IMPALA in which the FDA indicated that the data provided did not provide sufficient evidence of efficacy and safety for the treatment of aPAP.autoimmune Negative or inconclusive results could cause the FDA and other regulatory authorities to require us to repeat or conduct additional clinical trials, which could significantly increase the time and expense associated with development of that product candidate or cause us to elect to discontinue one or more clinical programs.PAP.

Significant uncertainty exists with respect to the regulatory approval process for any investigational new drug, including MOLBREEVI. Regardless of any guidance the FDA or foreign regulatory agencies may provide a drug’s sponsor during its development, the FDA or foreign regulatory agencies retain complete discretion in deciding whether to accept a BLA, or the equivalent foreign regulatory approval submission for filing or, if accepted, whether to approve a BLA. There are many components to a BLA or marketing authorization application submission in addition to clinical trial data. For example, the FDA or foreign regulatory agencies will review the sponsor’s internal systems and processes, as well as those of its CROs, CMOs, and other vendors, related to development of its product candidates, including those pertaining to its clinical studies and manufacturing processes. Before accepting a regulatory approval submission for review or before approving such submission, the FDA or foreign regulatory agencies may request that we provide additional information that may require significant resources and time to generate,generate. For example, in May 2025 we received the RTF requesting the Company provide additional data related to Chemistry, Manufacturing, and there is no guarantee that our product candidate will be approved for any indication for which we may apply.Controls. The FDA or foreign regulatory agencies may choose not to approve a BLA or its equivalent for a variety of reasons, including a decision related to the safety or efficacy data, manufacturing controls or systems, or for any other issues that the agency may identify related to the development of its product candidates. Even if one or more Phase 3 clinical trials are successful in providing statistically significant evidence of the efficacy and safety of the investigational drug, the FDA or foreign regulatory agencies may not consider efficacy and safety data from the submitted trials adequate scientific support for a conclusion of effectiveness and/or safety and may require one or more additional Phase 3 or other trials prior to granting marketing approval. If this were to occur, the overall development cost for the product candidate would be substantially greater and competitors may bring products to market before us, which could impair our ability to generate revenues from the product candidate, or even seek approval, if blocked by a competitor’s Orphan Drug exclusivity, which would have a material adverse effect on our business, financial condition, and results of operations.

Further, development of our product candidate and/or regulatory approval may be delayed for reasons beyond our control. Regulations or policies may be changed prior to submission of a marketing application that result in delays or require higher hurdles than currently anticipated. These may occur as a result of drug scandals, recalls, or a political environment unrelated to our products. For example, the FDA has granted MOLBREEVI for aPAPautoimmune PAP Fast Track and BTD, which are each designed to expedite the development and review of certain drugs. If there were a change in FDA policies and we were to lose those designations, it could cause delays in the regulatory review process. Additionally, changes in FDA priorities due to a new administration, layoffs, or U.S. federal government shut-downs or budget sequestrations, such as onesthe shut-down that occurred duringfrom JanuaryOctober 20181, and2025 Decemberuntil 2018November through12, January 2019,2025, may result in significant reductions to the FDA’s budget, employees, and operations, which may lead to slower response times and longer review periods, potentially affecting our ability to progress development of our product candidate or obtain regulatory approval for our product candidate.

Even if we receive regulatory approval for our product candidate,MOLBREEVI, we may face regulatory difficultiesrequirements that could materially and adversely affect our business, financial condition, and results of operations.

If our product candidateMOLBREEVI receives regulatory approval but fails to achieve significant market acceptance among the medical community, patients, or third-party payers, the revenue we generate from its sales will be limited and our business may never achieve profitability.

claims or other information (including limitations or warnings) in athe product’s approved labeling;

If we determine that aour product candidate may not achieve adequate market acceptance or that the potential market size does not justify additional expenditures on the program, we may reduce our expenditures on the development and/or the process of seeking regulatory approval of the product candidate while we evaluate whether and on what timeline to move the program forward.

We may require additional financing to obtainsupport regulatoryour approval for MOLBREEVIoperations and a failure to obtain this necessary capital when needed on acceptable terms, or at all, could force us to delay, limit, reduce, or terminate our product development efforts or other operations.

Since our Aravas subsidiary was formed in 2007, most of our resources have been dedicated to the development and acquisition of our product candidates, primarily MOLBREEVI. Our priority remains the continued development of MOLBREEVI for the treatment of aPAP.autoimmune PAP. We cannot estimate with reasonable certainty the actual amounts necessary to successfully complete the development and commercialization of our product candidate, and there is no certainty that we will be able to raise the necessary capital on reasonable terms or at all. If adequate funds are not available to us on a timely basis, we may be required to delay, limit, reduce, or terminate our establishment of sales and marketing, manufacturing or distribution capabilities, development activities, other activities that may be necessary to commercialize our product candidate, or conduct preclinical or clinical trials.

OurThe loanHercules agreementLoan Agreement contains covenants which may adversely impact our business; and the failure to comply with such covenants could cause our outstanding debt to become immediately payable or accelerate principal payments.

We are a party to an Amended and Restateda Loan and Security AgreementAgreement, dated March 26, 2025, with Siliconthe Valleylenders Bank,party now a division of First Citizens Bankthereto (the “AmendedLenders”) and Hercules Capital, Inc., as administrative agent and collateral agent, which was amended by the First Amendment dated January 26, 2026 (the “First Amendment”) (the loan agreement as amended, the “Hercules Loan Agreement”), pursuant to which we have borrowed $30 million of term loans and may borrow up to an additional $75 million of term loans if we are able to satisfy the conditions precedent described under Note 7. Debt Facility of the consolidated financial statements in this annual report on Form 10-K. As security for our borrowings under the Hercules Loan Agreement, we pledged substantially all of our assets, other than our intellectual property (which is subject to a negative pledge).assets. The AmendedHercules Loan Agreement includes a number of restrictive covenants, including restrictions on incurring additional debt, making investments, granting liens, disposing of assets, paying dividends, and redeeming or repurchasing capital stock, subjectand toa certainnumber exceptions.of affirmative covenants, including the Cash Requirement and the Conditional Minimum Revenue Covenant (as such terms are defined in Note 7. Debt Facility and Note 16. Subsequent Events of the consolidated financial statements in this annual report on Form 10-K). Collectively, these restrictive covenants could constrain our ability to grow our business through acquisitions or engage in other transactions. The AmendedHercules Loan Agreement includes customary events of default, such as our failure to pay amounts due, our failure to comply with covenants, or the occurrence of an event that would reasonably be expected to have a material adverse event on our business. Upon the occurrence and during the continuation of an event of default, Siliconthe Valley BankLenders could declare all outstanding loans under the AmendedHercules Loan Agreement immediately due and payable and exercise remedies against us and the collateral. Such an event would have a material adverse effect on our liquidity, financial condition, operating results, business, and prospects and cause the price of our common stock to decline. Refer to Note 7. Debt Facility of the consolidated financial statements in this annual report on Form 10-K for additional discussion.

We outsource the manufacture of our MOLBREEVI product candidate and do not plan to establish our own manufacturing facilities. To manufacture our product candidate, we have made numerous custom modifications at CMOs, making us highly dependent on these CMOs. For clinical and commercial supplies, if approved, we have supply agreements with third party CMOs for drug substance, finished drug product, drug delivery devices and other necessary components of our MOLBREEVI product candidate. While we have secured long-term commercial supply agreements with many of the third party CMOs, we would need to negotiate agreements for commercial supply with several important CMOs, and we may not be able to reach agreement on acceptable terms. In addition, we rely on these third parties to conduct or assist us in key manufacturing development activities, including qualification of equipment, developing and validating methods, defining critical process parameters, releasing component materials, demonstrating comparability of DSdrug substance and DP,drug product, and conducting stability testing, among other things. If these third parties are unable to perform their tasks successfully in a timely manner, whether for technical, financial, or other reasons, we may be unable to secure clinical trial material, or commercial supply material if approved, which likely would delay the initiation, conduct, or completion of our clinical trials or prevent us from having enough commercial supply material for sale, which would have a material and adverse effect on our business. There have been and could be additional delays in the manufacturing supply chain for our product candidate, including delays in procurement of materials for certain of our clinical trials, potentially resulting in delays in clinical trials and recruitment. Further, we have experienced an increase in costs associated with the supply chain disruption. The extent to which circumstances such as global health threats, global conflicts, and social unrest impact our ability to procure sufficient supplies for the development and commercialization of our product candidate going forward will depend on the severity and duration of such circumstances. For example, one of our primary CMOCMOs for drug substance operates in Argentina, which is experiencing high inflation, a weakening currency, labor strikes and social and political unrest. Those conditions could result in supply chain disruptions or increased costs.

MOLBREEVI has received Orphan Drug Designation from the FDA and the EMA. If a competitor obtains Orphan Drug exclusivity for a product with the same active ingredient and route of delivery as molgramostim for aPAP,autoimmune PAP, we may be unable to market our product candidate until the exclusivity of the competing product expires.

MOLBREEVI has received Orphan Drug Designation in the U.S. by the FDA and in Europe by the EMA for the treatment of aPAP.autoimmune PAP. If approval is received to market MOLBREEVI, the FDA will not approve a similar product, with the same active ingredient,ingredient toas MOLBREEVIMOLBREEVI, for seven years and the EMA will not approve a similar product to MOLBREEVI for ten years, unless we are unable to produce enough supply to meet demand in the marketplace or another similar product,product with the same active ingredient,ingredient is deemed clinically superior. Similar product candidates,candidates with the same active ingredient and route of delivery,delivery may be granted Orphan Drug Designation during the development, but the Orphan Drug exclusivity is granted only to the first of such products approved, which means there is risk that a competitor product candidate may receive approval and Orphan Drug exclusivity before us, thus preventing us from marketing our product candidate until the exclusivity of the competing product expires. Also, the Orphan Drug status will not prevent a competitor with a different active ingredient from competing with our product candidate. If we are prevented from marketing MOLBREEVI for aPAPautoimmune PAP due to a competitor’s Orphan Drug exclusivity, it would have a material adverse effect on our business.

The development and commercialization of new drug products is highly competitive and subject to rapid and significant change. Developments by others may render potential application of our MOLBREEVI product candidate in aPAPautoimmune PAP obsolete or noncompetitive, even prior to completion of its development and approval. If successfully developed and approved, we expect our product candidate will face competition. We may not be able to compete successfully against organizations with competitive products, particularly large pharmaceutical companies. Many of our potential competitors have significantly greater financial, technical, and human resources than us, and may be better equipped to develop, manufacture, market, and distribute products. Many of these companies operate large, well-funded research, development, and commercialization programs, have extensive experience in nonclinical and clinical trials, obtaining FDA and other regulatory approvals, and manufacturing and marketing products, and have multiple products that have been approved or are in late-stage development. These advantages may enable them to receive approval from the FDA or any foreign regulatory agency before us and prevent us from competing due to their orphan drug protections. Smaller companies may also prove to be significant competitors, particularly through collaborative arrangements with large pharmaceutical and biotechnology companies. Furthermore, heightened awareness on the part of academic institutions, government agencies, and other public and private research organizations of the potential commercial value of their inventions have led them to actively seek to commercialize the technologies they develop, which increases competition for investment in our programs. Competitive products may be more effective, easier to dose, or more effectively marketed and sold than ours, which would have a material adverse effect on our ability to generate revenue.

Although we are not aware of any companies developing an inhaled form of GM-CSF for the treatment of aPAP,autoimmune PAP, sargramostim (Leukine), a yeast-derived recombinant human granulocyte-macrophage colony stimulating factor, rhu-GM-CSF, which is a product of Partner Therapeutics, Inc., is being pharmacy-compounded and utilized by some patients in the U.S. for the off-label treatment of aPAP.autoimmune PAP. We cannot assess the effectiveness of its off-label administration to patients with aPAPautoimmune PAP or the number of aPAPautoimmune PAP patients in the U.S. using Leukine as a pharmacy-compounded off-label treatment. Additionally, in April 2024, Partner Therapeutics’ partner, Nobelpharma Co. Ltd., received regulatory approval from the PMDA to market sargramostim for the treatment of aPAPautoimmune PAP in Japan. Sargramostim has the potential to present a material competitive threat to the commercial success of MOLBREEVI in Japan which could have a material adverse effect on our business.

We rely on IT systems, including third-party “cloud based” service providers, to keep financial records, maintain laboratory data, clinical data and corporate records, communicate with staff and external parties, and operate other critical functions. This includes critical systems such as email, other communication tools, electronic document repositories, and archives. If any of these third-party IT providers are compromised due to computer viruses, unauthorized access, malware, natural disasters, fire, terrorism, war andwar, telecommunication failures, electrical failures, cyber-attacks, or cyber-intrusions over the internet, then sensitive emails or documents could be exposed or deleted. Similarly, we could incur business disruption if our access to the internet is compromised, and we are unable to connect with third-party IT providers. The risk of a security breach or disruption, particularly through cyber-attacks or cyber-intrusion by computer hackers, foreign governments, or cyber-terrorists, has generally increased as the number, intensity, and sophistication of attempted attacks and intrusions from around the world have increased. In addition, we rely on those third parties to safeguard important confidential personal data regarding our employees and patients enrolled in our clinical trials. If a disruption event were to occur and cause interruptions in a third-party IT provider’s operations, it could result in a disruption of our drug development programs. For example, the loss of clinical trial data from completed, ongoing, or planned clinical trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data. To the extent that any disruption or security breach results in loss or damage to our data or applications or inappropriate disclosure of confidential or proprietary information, we could incur liability and development of our product candidate could be delayed or could fail.

WeIn the ordinary course of business, we collect, receive, use, retain, transfer, and otherwise process, personal data and other sensitive and confidential information. As a result of our data processing activities, we are subject to a number of state, national, and foreign laws and regulations related to the collection, use, retention, protection, disclosure, transfer, and other processing of personal data, including the EU’s General Data Protection Regulation (“GDPR”). in the EU, the UK GDPR and Data Protection Act 2018 in the UK, and numerous federal and state laws in the U.S. The scope of these laws can be broad, and the statutory penalties can be high. For example, the GDPR imposes stringent requirements for the processing of personal data of individuals within the EU and provides for substantial penalties for non-compliance that can be up to the greater of €20 million or 4% of global annual revenues.

The legal landscape in this area is rapidly evolving as different jurisdictions adopt new laws governing data privacy, which can differ in scope and applicability, subject to different interpretations, and be inconsistent among jurisdictions. In 2018,the U.S., California enacted the California Consumer Privacy Act ofin 2018, which requires covered companies to provide new disclosures to California consumers and affords those consumers new rights related to their personal data, including the right to opt-out of certain sales of personal information and a private right of action for certain breaches.data. Since then, a number of otheradditional states have adopted their own comprehensive data privacy laws,laws. whichOutside arethe U.S., in addition to the GDPR and UK statutes referenced above, many jurisdictions either currentlyhave effectivedata protection laws in place or scheduledcontinue to becomeadvance effective.proposals Infor Canada,similar both the federal governmentlegislation and certainregulation. provincesThe haveincreasing alsonumber, proposed new legislation imposing significantcomplexity, and unprecedentedpotential obligations,inconsistency fines,of current and liabilitiesfuture regardinglaws and regulations relating to privacy, data handling. As the applicable laws change, we may be required to implement additional mechanisms to comply, which may be difficult to implementprotection, and may require us to incur additional costs. If we or our vendors fail to comply with applicable data privacy laws, we could be subject to government enforcement actions and significant penalties, and our business could be adversely impacted. A data security breach or change in applicable privacy or security laws or regulations could require us to devote significant management resources to address the problemsU.S. createdand byother thecountries breach or such change in laws or regulations, and, further, to expend significant additional resources to upgrade the security measures that we employ to guard against such breaches or comply with such change in laws or regulations, each of which could disruptmake our business,compliance operations,obligations more difficult and financial condition.costly. Because many of these laws are new, there is little clarity as to their interpretation, as well as a lack of precedent for the scope of enforcement. AlthoughAs the laws to which we planare subject increase and the requirements change, we may be required to continueimplement additional mechanisms to workcomply, which may be difficult and require us to preventincur breachesadditional andcosts. ensureIf compliancewe or our vendors fail to comply with applicable data privacy laws regardingor theexperience protectiona andbreach of security that results in unauthorized disclosure of personal information, ourwe efforts maycould be unsuccessfulsubject to government investigations and resultenforcement inactions, significant costs.penalties, civil litigation, and reputational harm, and our business could be adversely impacted.

WeOur havecommercial nosuccess issueddepends patentson forour ability to adequately protect our intellectual property rights related to MOLBREEVI for the treatment of aPAPautoimmune andPAP. primarilyWe intend to rely on theregulatory exclusivity, such as through Orphan Drug exclusivityexclusivity, as our primary barrier to competition. Additionally, we have an exclusive supply agreement for the proprietary delivery device used for MOLBREEVI and a proprietary cell bank used in the production of the drug substance. Our success will depend on our ability to:

WeIn addition to regulatory exclusivity, we have filedsought to protect our intellectual property rights by filing patent applications related to our MOLBREEVI product candidate; however, there is no guarantee that patents will issue from any pending or future applications or that claims allowed will be sufficient to protect the technology we develop or that is used by us, our CMOs, or our other service providers. The patent prosecution process is expensive and time-consuming; we may not be able to file or prosecute patents on certain aspects of our product candidate at a reasonable cost, in a timely fashion, or at all, and we may fail to identify patentable aspects of inventions made during development activities before it is too late to obtain patent protection. Further, defects of form in the preparation or filing of our patent applications may exist, or may arise in the future, which may cause them to be invalid or unenforceable.

Our ability to successfully commercialize our product will depend on the extent to which governmental authorities, private health insurers, and other organizations establish what we believe are appropriate coverage and reimbursement for our product. The containment of healthcare costs has become a priority of federal and state governments worldwideworldwide, and the prices of drug products have been a focus in this effort. For example, therePresident haveTrump beenhas severalsigned recentmultiple U.S.executive Congressionalorders inquiriesaddressing and proposed bills designed to, among other things, bring more transparency toprescription drug pricing, review the relationship between pricing and manufactureraccess, patientincluding programs,one in May 2025 aiming to establish a “most favored nation” (“MFN”) drug pricing policy, which would tie U.S. drug prices to the lowest prices paid for drugs in other countries. Certain manufacturers have entered into voluntary agreements with the Trump Administration on MFN pricing, and reformthe government program reimbursement methodologiesCenters for drugs,Medicare & Medicaid Services has announced initiatives that would take steps to implement MFN pricing for Medicaid and thenMedicare PresidentParts TrumpB signedand fourD executiveprograms. ordersAdoption or expansion of MFN pricing policies could result in downward pressure on JulyU.S. 24,pricing 2020and aimedmay atimpact bringingour downdecision pharmaceuticalabout prices.when or whether to launch MOLBREEVI in markets outside of the U.S., if approved. We expect that federal, state, and local governments in the U.S., as well as in other countries, will continue to consider legislation directed at lowering the total cost of healthcare. In addition, in certain foreign markets, the pricing of drug products is subject to government controlcontrol, and reimbursement may in some cases be unavailable or insufficient. It is uncertain whether and how future legislation, whether domestic or abroad, could affect prospects for our product candidate or what actions federal, state, or private payers for healthcare treatment and services may take in response to any such healthcare reform proposals or legislation.

Furthermore, we expect that healthcare reform measures that may be adopted in the future are unpredictable, and the potential impact on our operations and financial position is uncertain, but may result in more rigorous coverage criteria, lower reimbursement, and additional downward pressure on the price we may receive for approved products. Any reduction in reimbursement from Medicare or other government-funded programs may result in a similar reduction in payments from private payers. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize our products, if approved.

adverse publicity relating to the aPAPautoimmune PAP market generally, including with respect to other products and potential products in such market;

In the past, following periods of volatility in the market price of a company’s securities, such as the decline in our stock price, stockholders have often instituted class action securities litigation against those companies. For example, in September 2025, a putative class action complaint was filed against the Company and certain of our executive officers asserting violations of federal securities laws, as further described in Note 10. Commitments in the notes to our consolidated financial statements in this annual report on Form 10-K. Such litigation, if instituted, could result in substantial costs and diversion of management attention and resources, which could significantly harm our profitability and reputation.

Savara Inc. (together with its subsidiaries “Savara,” the “Company,” “we,” “our” or “us”) is a clinical-stage biopharmaceutical company focused on rare respiratory diseases. Our sole program, MOLBREEVI, is an inhaled biologic, specifically,is inhaleda granulocyte-macrophage colony-stimulating factor ("GM-CSF") in Phase 3 development for aPAP.autoimmune pulmonary alveolar proteinosis ("autoimmune PAP"). Savara previously announced positive top-linetopline results from IMPALA-2, the Phase 3 clinical trial of MOLBREEVI in autoimmune PAP and plansthe tosubmission completeof athe BiologicalBiologics License Application submission("BLA") withto the FDA for MOLBREEVI in autoimmune PAP. In May 2025, Savara announced the firstCompany quarterhad ofreceived 2025.a Refusal to File letter ("RTF") from the FDA. The Company resubmitted the BLA in December 2025 and requested Priority Review, and the FDA formally filed the BLA for MOLBREEVI in February 2026 and granted Priority Review. MOLBREEVI in autoimmune PAP has been granted Fast Track and Breakthrough Therapy Designations by the FDA, Orphan Drug Designation by the FDA and the European Medicines Agency ("EMA"), as well as Innovation Passport ("IP") and Promising Innovative Medicine ("PIM") designations by the UK’s Medicines and Healthcare Products Regulatory Agency ("MHRA"). Savara, together with its wholly-owned subsidiaries, which include Aravas Inc. and Savara ApS, operate in one segment with its principal office in Langhorne, Pennsylvania, though a majority of our employees work remotely.

On MarchJanuary 26, 2025,2026, the Company announced that it hadwe entered into a Loan and Security Agreement (the “First Amendment to the Hercules Loan Agreement”)Agreement. withAs amended, the lenders party thereto (the “Lenders”) and Hercules Capital, Inc., as administrative agent and collateral agent (the “Agent”). The Hercules Loan Agreement provides for the Company to borrow up to $200an aggregate of $105 million of term loans (the “Term Loan”) that may be advanced in multiple tranches.loans.

SubjectPursuant to approvalthe byFirst Amendment, upon achievement of the Lenders’Approval investment committees,Milestone, the Company may drawborrow up to $70$75 million of additional funds.term loans under the Loan Agreement, as follows:

Research and development expenses increased $33.8$3.4 million, or 76.3%,4.3%, to $81.4 million for the year ended December 31, 2025 from $78.0 million for the year ended December 31, 2024 from $44.3 million for the year ended December 31, 2023.2024. This increase is primarily due to the performance of tasks related to our MOLBREEVI programprogram, which includes approximately$5.7 $19.9million of costs related to regulatory affairs and quality assurance, primarily driven by the BLA submission; $0.5 million of costs related to our chemistry, manufacturing, and controls activities,activities; primarily driven by initiatives to establish our second drug substance manufacturer, $2.8$1.0 million of costs related to our IMPALA-2 trial, IMPACT trial, and Savara EAP, including CRO-related activities, $4.1 million of costs related to regulatory affairs and quality assurance, and $7.0 million due to an increase in personnel and related costs and other departmental overhead.overhead; partially offset by a decrease of $3.8 million in clinical costs.

General and administrative expenses increased $9.4$17.0 million, or 59.8%,68.0%, to $42.1 million for the year ended December 31, 2025 from $25.0 million for the year ended December 31, 2024 from $15.7 million for the year ended December 31, 2023.2024. The increase is due to higher personnel and related costscosts, in terms of $4.3compensation million,and an increase in valuation and stock awards, driven by strategic workforce expansion to support and scale operations of $11.2 million; certain commercial activities of $3.8$3.1 million,million; and other overhead of $1.3$2.7 million primarily driven by expanded patient advocacy activities and consultantmedical costs.affairs activities.

Other income, net increaseddecreased $2.0$2.6 million to $4.7 million for the year ended December 31, 2025 from $7.3 million for the year ended December 31, 2024 from $5.3 million for the year ended December 31, 2023.2024. The increasedecrease is primarily related to an increase inlower interest income as a result of higherreduced balances and moreless favorable rates and returns on our short-term investmentsinvestments, followingin various equity financings. Referaddition to Notea 9.loss Stockholders’on Equityextinguishment of the consolidated financial statements in this annual report on Form 10-K for additional discussion of the July 2024 Offering.debt.

As discussed in Note 7. Debt Facility and Note 16. Subsequent Events in the notes to the consolidated financial statements in this annual report on Form 10-K, on March 26, 2025, we entered into the Hercules Loan Agreement which was amended by the First Amendment on January 26, 2026. As amended, the Hercules Loan Agreement provides for athe loanCompany facilityto ofborrow up to $200an million.aggregate of $105 million of term loans. Proceeds from the initial $30 million tranche drawn under the Hercules Loan Agreement were used to repay all outstanding obligations under the Amended Loan Agreement with Silicon Valley Bank, a division of First Citizens BancShares, with a carrying value of $26.6$29.9 million as described in Note 16. Subsequent Events,million, to pay certain expenses incurred in connection with the financing, and for general corporate purposes. SubjectThe First Amendment reset the timing and conditions to satisfactionthe Company’s ability to draw up to $75 million of certainadditional conditions,term including attainment of FDA approval of MOLBREEVI for the treatment of aPAP, we may draw future tranchesloans under the Hercules Loan AgreementAgreement, subject in each case to fund our ongoing business operations including the development,Approval regulatory approval, marketing and commercialization of MOLBREEVI.Milestone.

As of December 31, 2024,2025, we had cash, cash equivalents, and short-term investments of $196.3$235.7 million. Although we have sufficient capital to fund our planned activities, including those discussed in Note 10. Commitments – Manufacturing and Other of the consolidated financial statements in this annual report on Form 10-K, we may need to raise additional capital to further fund the development of,of and seek regulatory approvals for our product candidate and to begin commercialization of any approved product. The amount and timing of our future funding requirements will depend on many factors, including the pace and results of our clinical development efforts. Failure to raise capital as and when needed, on favorable terms or at all, would have a negative impact on our financial condition and our ability to develop our product candidate.

Refer to Note 2. Summary of Significant Accounting Policies – Recent Accounting Pronouncements, of the consolidated financial statements in this annual report on Form 10-K milestone for a discussion of recent accounting pronouncements and their effect, if any, on us.

Savara Inc. (together with its subsidiaries “Savara,” the “Company,” “we,” “our” or “us”) is a clinical-stage biopharmaceutical company focused on rare respiratory diseases. Our sole program, MOLBREEVI,MOLBREEVI[1], an inhaled biologic, is a granulocyte-macrophage colony-stimulating factor (“GM-CSF”) in development for autoimmune pulmonary alveolar proteinosis ("autoimmune PAP"). Savara previously announced positive topline results from IMPALA-2, the Phase 3 clinical trial of MOLBREEVI for the treatment of autoimmune PAP and the submission of the Biologics License Application ("BLA") to the FDA for MOLBREEVI in autoimmune PAP. In February 2026, the FDA formally filed the BLA for MOLBREEVI and granted Priority Review. In March 2026, the European Medicines Agency (“EMA”) validated the submission of the MOLBREEVI marketing authorization application (“MAA”) in autoimmune PAP which will be reviewed by the Committee for Medicinal Products for Human Use. In April 2026, Savara announced that the U.K. Medicines and Healthcare Products Regulatory Agency (“MHRA”) validated the submission of the MOLBREEVI MAA for the treatment of autoimmune PAP in the U.K. subject to Accelerated Review with a 150-day assessment duration. In April 2026, Savara announced that the FDA extended the review period for the MOLBREEVI BLA to allow the FDA additional time to complete their review. The FDA determined that the Company’s responses to recent information requests by the Agency during their review constituted a major amendment to the BLA, resulting in a three-month extension of the Prescription Drug User Fee Act ("PDUFA") target action date to November 22, 2026. MOLBREEVI for the treatment of autoimmune PAP has been granted Fast Track and Breakthrough Therapy Designations by the FDA, Orphan Drug Designation by the FDA and the EMA, as well as Innovation Passport ("IP") and Promising Innovative Medicine ("PIM") designations by the MHRA. Savara, together with its wholly-owned subsidiaries, which include Aravas Inc. and Savara ApS, operate in one segment with its principal office in Langhorne,Yardley, Pennsylvania, though a majority of our employees work remotely.

Since inception, we have devoted our efforts and resources to identifying and developing our product candidates, recruiting personnel, and raising capital. We have incurred operating losses and negative cash flow from operations and have no product revenue from inception to date. From inception to MarchJune 31,30, 2026, we have raised net cash proceeds of approximately $738.1 million, primarily from underwritten offerings of our common stock, private placements of common stock, and debt financings.

We have never been profitable and have incurred operating losses every year since inception. Our net losses for the three months ended MarchJune 31,30, 2026 and 2025 were $37.3$40.2 million and $26.6$30.4 million, respectively. The net loss for the year ended December 31, 2025 was $118.8 million. As of MarchJune 31,30, 2026, we had an accumulated deficit of approximately $645.4$685.6 million. Our operating losses primarily resulted from expenses attributed to our research and development programs and from general and administrative costs associated with our operations.

As of MarchJune 31,30, 2026, we had cash and cash equivalents of $38.8$41.8 million and short-term investments of $164.0$131.2 million. We will continue to require additional capital to continue our clinical development and potential commercialization activities. Although we have sufficient capital to fund many of our planned activities, we may need to continue to raise additional capital to further fund the development of, and seek regulatory approvals for, our product candidate and begin to commercialize any approved product. The amount and timing of our future funding requirements will depend on many factors, including the pace and results of our clinical development efforts and regulatory and commercial variability. Failure to raise capital as and when needed, on favorable terms or at all, would have a negative impact on our financial condition and our ability to develop our product candidate.

General and administrative ("G&A") expenses consist primarily of consist of salaries, benefits and other related costs, including stock-based compensation, for our non-employee directors and personnelemployees primarily serving in our executive, financefinance, and accounting, legal and compliance,legal, commercial and pre-commercial, corporate development, field sales and human resourceresources functions. G&A expenses also include but are not limited to professional fees for legal services, insurance, facility lease, investor relations, business development, board of director fees, consulting services, including information technology and tax and accounting services.

Other income (expense) includes amortization expense related to capitalized debt issuance costs and debt discount under our loan agreements. Refer to Note 6. Debt Facility in the notes to the condensed consolidated financial statements included in this Quarterly Report. Interest expense is typically reported net of interest income which includes interest earned on our cash, cash equivalent,equivalents, and short-term investment balances. Other income (expense) also includes net unrealized and realized gains and losses from foreign currency transactions, loss on extinguishment of debt, refundable tax credits generated by some of our foreign subsidiaries, and securities subject to fair value accounting as well as any other non-operating gains and losses.

There have not been any material changes during the threesix months ended MarchJune 31,30, 2026, to the methodology applied by management for critical accounting policies previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2025. Please read Part II, Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations – Critical Accounting Policies and Estimates in our Annual Report on Form 10-K for the year ended December 31, 2025, for further description of our critical accounting policies.

Results of Operations – Comparison of Three Months Ended MarchJune 31,30, 2026 and 2025

Research and development expenses increased by $4.2$1.2 million, or 22.1%,5.8%, to $23.4$22.0 million for the three months ended MarchJune 31,30, 2026 from $19.2$20.8 million for the three months ended MarchJune 31,30, 2025. ThisThe increase iswas primarily due to $2.0 million of higher personnel costs, mainly related to increased stock-based compensation expense; partially offset by the performance of tasks related to our MOLBREEVI program, which includes approximatelya $2.5decrease of $0.2 million of costs related to our chemistry, manufacturing, and controls activities, primarily driven by activity at our drug substance manufacturer;manufacturer, $3.0 million of higher personnel costs, mainly related to increased share based compensation expense; partially offset byand a decrease of $0.7$0.6 million of costs related to regulatory affairs consulting and quality assurance consulting and a decrease of $0.6 million of clinical costs.

General and administrative expenses increased by $6.3$8.3 million, or 68.4%,78.2%, to $15.6$19.0 million for the three months ended MarchJune 31,30, 2026 from $9.2$10.7 million for the three months ended MarchJune 31,30, 2025. The increase iswas primarily attributable to $6.0$7.5 million of higher personnel costs, mainlydriven related toby increased share basedstock-based compensation expense; otheras departmentalwell overheadas increased headcount growth as we build out our commercial team ahead of $0.6and million,in partiallysupport offsetof byour aplanned decreaseproduct launch, in addition to an increase of $0.8 million in certain commercial activitiesactivities. ofThese $0.3investments million.reflect our strategy to establish the commercial infrastructure necessary to support an effective and timely launch.

There waswere no significant changes in Other income, net for the three months ended MarchJune 31,30, 2026 from the three months ended MarchJune 31,30, 2025.

As of MarchJune 31,30, 2026, we had $38.8$41.8 million of cash and cash equivalents, $164.0$131.2 million in short-term investments, and an accumulated deficit of approximately $645.4$685.6 million. As discussed in Note 6. Debt Facility in the notes to the condensed consolidated financial statements included in this Quarterly Report, on March 26, 2025, we entered into the Hercules Loan Agreement, which, as amended, which provides for a loan facility of up to $105 million. Proceeds from the initial $30 million tranche drawn under the Hercules Loan Agreement, with a carrying value of $30.1 million, were used to repay all outstanding obligations under the SVB Loan, pay certain expenses incurred in connection with the financing, and for general corporate purposes. Subject to satisfaction of certain conditions, including attainment of FDA approval of MOLBREEVI for the treatment of autoimmune PAP, we may draw future tranches under the Hercules Loan AgreementAgreement, as amended, and the royalty purchase and sale agreement with RTW Investments, LP, as discussed in Note 9. Commitments and Contingencies, to fund our ongoing business operations including the development, regulatory approval, marketing and commercialization of MOLBREEVI. Refer to Note 6. Debt Facility of the unaudited condensed consolidated financial statements in this quarterly report on Form 10-Q for additional discussion.

Cash used in operating activities for the threesix months ended MarchJune 31,30, 2026 was $33.0$62.8 million, consisting of a net loss of $37.3$77.5 million and net $6.1$3.1 million in changes to operating assets and liabilities, offset by $10.4$17.8 million of net noncash charges. Net noncash charges are comprised primarily of stock-based compensation, accretion on discount to short-term investments, and amortization of debt issuance costs.

Cash provided by investing activities of $38.8$71.4 million for the threesix months ended MarchJune 31,30, 2026 was primarily associated with proceeds from maturities of short-term investments and salepurchases and sales of short-term investments.

As of MarchJune 31,30, 2026, we had cash, cash equivalents, and short-term investments of approximately $202.8$173.0 million. Although we have sufficient capital to fund our planned activities, including those discussed in Note 9. Commitments – Manufacturing and Other Commitments and Contingencies, in the notes to the condensed consolidated financial statements included in this Quarterly Report, we may need to raise additional capital to further fund the development of, and seek regulatory approvals for, our product candidate and to begin commercialization of any approved product.

Except as set forth in Note 2. Summary of Significant Accounting Policies – Recent Accounting Pronouncements of the condensed consolidated financial statements in this Quarterly Report, there have been no material changes in our critical accounting policies and use of estimates during the threesix months ended MarchJune 31,30, 2026 as compared to those disclosed in “Part II, Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Policies and Estimates” in the our Annual Report on Form 10-K for the year ended December 31, 2025.