Savara Inc

Previous wording

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, molgramostim, is an inhaled biologic, specifically, inhaled granulocyte-macrophage colony-stimulating factor in Phase 3 development for aPAP. 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 as of March 31, 2024, though a majority of our employees work remotely.

Current wording

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, molgramostim, is an inhaled biologic, specifically, inhaled granulocyte-macrophage colony-stimulating factor in Phase 3 development for aPAP. 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.

Previous wording

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 March 31, 2024, we have raised net cash proceeds of approximately $476.7 million, primarily from public offerings of our common stock, private placements of convertible preferred stock, and debt financings.

Current wording

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 June 30, 2024, we have raised net cash proceeds of approximately $476.7 million, primarily from underwritten offerings of our common stock, private placements of common stock, and debt financings.

Previous wording

We have never been profitable and have incurred operating losses every year since inception. Our net losses for the three months ended March 31, 2024 and 2023 were $20.3 million and $10.6 million, respectively, and the net loss for the year ended December 31, 2023 was $54.7 million. As of March 31, 2024, we had an accumulated deficit of approximately $413.7 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.

Current wording

We have never been profitable and have incurred operating losses every year since inception. Our net losses for the three months ended June 30, 2024 and 2023 were $22.2 million and $11.4 million, respectively, and the net loss for the year ended December 31, 2023 was $54.7 million. As of June 30, 2024, we had an accumulated deficit of approximately $436.0 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.

Previous wording

As of March 31, 2024, we had cash and cash equivalents of $16.8 million and short-term investments of $126.3 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. 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.

Current wording

As of June 30, 2024, we had cash and cash equivalents of $23.9 million and short-term investments of $97.7 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. 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.

Previous wording

There have not been any material changes during the three months ended March 31, 2024, 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, 2023. 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, 2023, for further description of our critical accounting policies.

Current wording

There have not been any material changes during the six months ended June 30, 2024, 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, 2023. 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, 2023, for further description of our critical accounting policies.

Previous wording

Research and development expenses increased by $8.1 million, or 92.3%, to $16.8 million for the three months ended March 31, 2024 from $8.7 million for the three months ended March 31, 2023. This increase is primarily due to the performance of tasks related to our molgramostim program, which includes approximately $4.3 million of costs related to our chemistry, manufacturing, and controls activities, primarily driven by initiatives at our second drug substance manufacturers, $1.0 million of costs related to our IMPALA-2 trial, including CRO-related activities, $0.6 million of costs related to regulatory affairs and quality assurance, and $2.2 million due to an increase in personnel and related costs.

Current wording

Research and development expenses increased by $8.7 million, or 97.7%, to $17.6 million for the three months ended June 30, 2024 from $8.9 million for the three months ended June 30, 2023. This increase is primarily due to the performance of tasks related to our molgramostim program, which includes approximately $4.8 million of costs related to our chemistry, manufacturing, and controls activities, primarily driven by initiatives to establish our second drug substance manufacturer, $1.2 million of costs related to our IMPALA-2 trial and Pediatric Study, including CRO-related activities, $1.3 million of costs related to regulatory affairs and quality assurance, and $1.4 million due to an increase in personnel including related costs and other departmental overhead.

Previous wording

General and administrative expenses increased by $2.3 million, or 67.4%, to $5.6 million for the three months ended March 31, 2024 from $3.4 million for the three months ended March 31, 2023. The increase is due to personnel and related costs of $0.6 million, certain commercial activities of $1.1 million, and other overhead of $0.6 million primarily driven by patient advocacy activities.

Current wording

General and administrative expenses increased by $2.2 million, or 67.8%, to $5.5 million for the three months ended June 30, 2024 from $3.3 million for the three months ended June 30, 2023. The increase is due to personnel and related costs of $1.1 million, certain commercial activities of $0.8 million, and other overhead of $0.3 million primarily driven by consultant costs.

Previous wording

Other income, net increased by $0.6 million to $2.1 million for the three months ended March 31, 2024 from $1.6 million for the three months ended March 31, 2023. The increase is primarily related to the increase in Interest income during the three months ended March 31, 2024 as a result of both an increase in our short-term investments following various equity financings and an increase in market interest rates.

Current wording

Other income, net increased by approximately $0.7 million to $3.1 million for the six months ended June 30, 2024 from $2.3 million for the six months ended June 30, 2023. The increase is primarily related to the increase in Interest income during the six months ended June 30, 2024 as a result of both an increase in our short-term investments following various equity financings and an increase in market interest rates.

Previous wording

As of March 31, 2024, we had $16.8 million of cash and cash equivalents, $126.3 million in short-term investments, and an accumulated deficit of approximately $413.7 million. As discussed in Note 6. Long-term Debt in the notes to the condensed consolidated financial statements included in this Quarterly Report, during April 2022, we entered into an Amended Loan Agreement with Silicon Valley Bank that provided for a $26.5 million term loan facility, the proceeds of which were used to refinance all outstanding obligations under our pre-existing loan agreement with Silicon Valley Bank.

Current wording

As of June 30, 2024, we had $23.9 million of cash and cash equivalents, $97.7 million in short-term investments, and an accumulated deficit of approximately $436.0 million. As discussed in Note 6. Long-term Debt in the notes to the condensed consolidated financial statements included in this Quarterly Report, during April 2022, we entered into an Amended Loan Agreement with Silicon Valley Bank that provided for a $26.5 million term loan facility, the proceeds of which were used to refinance all outstanding obligations under our pre-existing loan agreement with Silicon Valley Bank.

Previous wording

We have used and intend to use our liquidity and capital for working capital and general corporate purposes, which include, but are not limited to, the funding of clinical development of and pursuing regulatory approval for our product candidate and general and administrative expenses. As we continue to progress on the IMPALA-2 trial, we will continue to monitor our liquidity and capital requirements.

Current wording

We have used and intend to use our liquidity and capital for working capital and general corporate purposes, which include, but are not limited to, the funding of clinical development of and pursuing regulatory approval for our product candidate and general and administrative expenses. As we continue to progress on the IMPALA-2 trial, pursue regulatory approval, and invest in pre-commercial activities, we will continue to monitor our liquidity and capital requirements.

Previous wording

Cash used in operating activities for the three months ended March 31, 2024 was $20.6 million, consisting of a net loss of $20.3 million and net $1.3 million in changes due to operating assets and liabilities. This was partially offset by approximately $1.0 million of net noncash charges (comprised of depreciation and amortization including right-of-use assets, accretion on premium to short-term investments, amortization of debt issuance costs, foreign currency, and stock-based compensation).

Current wording

Cash used in operating activities for the six months ended June 30, 2024 was $43.1 million, consisting of a net loss of $42.6 million and net $2.9 million in changes due to operating assets and liabilities. This was partially offset by approximately $2.4 million of net noncash charges (comprised of depreciation and amortization including right-of-use assets, accretion on premium to short-term investments, amortization of debt issuance costs, foreign currency, and stock-based compensation).

Previous wording

Cash provided by investing activities of $10.8 million for the three months ended March 31, 2024 was primarily associated with proceeds from the maturities of short-term investments partially offset by cash used for purchases of short-term investments.

Current wording

Cash provided by investing activities of $40.3 million for the six months ended June 30, 2024 was primarily associated with proceeds from the maturities of short-term investments partially offset by cash used for purchases of short-term investments.

Previous wording

Cash provided by financing activities was minimal for the three months ended March 31, 2024.

Current wording

Cash provided by financing activities was minimal for the six months ended June 30, 2024.

Previous wording

As of March 31, 2024, we had cash, cash equivalents, and short-term investments of approximately $143.0 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 continue 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. 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.

Current wording

As of June 30, 2024, we had cash, cash equivalents, and short-term investments of approximately $121.5 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 continue 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. 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.