ALX ONCOLOGY HOLDINGS INC

Previous wording

In April 2023, we announced a collaboration with Sanofi who will sponsor and manage a Phase 1/2 trial of SARCLISA® (isatuximab), an anti-cancer antibody, and dexamethasone in combination with evorpacept for the treatment of patients with relapsed or refractory multiple myeloma.

Current wording

In April 2023, we announced a collaboration with Sanofi who will sponsor and manage a Phase 1/2 trial of SARCLISA® (isatuximab), an anti-cancer antibody, and dexamethasone in combination with evorpacept for the treatment of patients with relapsed or refractory multiple myeloma. We announced the dosing of the first patients in September 2024.

Previous wording

In March 2022, we filed a universal shelf registration statement (Shelf Registration Statement), which provides for aggregate offerings of up to $450.0 million of the Company’s securities. In May 2022, we filed an amendment to the Shelf Registration Statement, which was declared effective by the Securities and Exchange Commission (SEC) on May 31, 2022. We believe that our Shelf Registration Statement provides us with flexibility to raise additional capital to finance our operations as needed. In December 2021, we entered into a sales agreement (as amended, Sales Agreement) with Cantor Fitzgerald & Co. and Credit Suisse Securities (USA) LLC (Credit Suisse), under which we may, subject to the effectiveness of the Shelf Registration Statement, offer and sell our common stock, having aggregate gross proceeds of up to $150.0 million, from time to time through them as our sales agents in an at-the-market (ATM) offering. In August 2023, we entered into an amendment to the Sales Agreement to include UBS Securities LLC as an additional sales agent and to remove Credit Suisse as a sales agent. As of June 30, 2024, we had issued approximately 2,005,910 shares of common stock pursuant to the Sales Agreement for net proceeds of $29.2 million. We may terminate this ATM program at any time, pursuant to its terms.

Current wording

In March 2022, we filed a universal shelf registration statement (Shelf Registration Statement), which provides for aggregate offerings of up to $450.0 million of the Company’s securities. In May 2022, we filed an amendment to the Shelf Registration Statement, which was declared effective by the Securities and Exchange Commission (SEC) on May 31, 2022. We believe that our Shelf Registration Statement provides us with flexibility to raise additional capital to finance our operations as needed. In December 2021, we entered into a sales agreement (as amended, Sales Agreement) with Cantor Fitzgerald & Co. and Credit Suisse Securities (USA) LLC (Credit Suisse), under which we may, subject to the effectiveness of the Shelf Registration Statement, offer and sell our common stock, having aggregate gross proceeds of up to $150.0 million, from time to time through them as our sales agents in an at-the-market (ATM) offering. In August 2023, we entered into an amendment to the Sales Agreement to include UBS Securities LLC as an additional sales agent and to remove Credit Suisse as a sales agent. As of September 30, 2024, we had issued approximately 2,005,910 shares of common stock pursuant to the Sales Agreement for net proceeds of $29.3 million. We may terminate this ATM program at any time, pursuant to its terms.

Previous wording

From inception through June 30, 2024, we have raised an aggregate of $642.7 million to fund our operations, of which $175.1 million were net proceeds from sales of our convertible preferred stock, $5.8 million were net proceeds from borrowings under a term loan, $169.5 million were net proceeds from our initial public offering, $194.9 million were net proceeds from our follow-on offering in December 2020, $9.3 million were net proceeds from borrowings under the Loan Agreement, $58.9 million were net proceeds from our follow-on offering in October 2023, and $29.2 million were net proceeds from our ATM offering.

Current wording

From inception through September 30, 2024, we have raised an aggregate of $642.8 million to fund our operations, of which $175.1 million were net proceeds from sales of our convertible preferred stock, $5.8 million were net proceeds from borrowings under a term loan, $169.5 million were net proceeds from our initial public offering, $194.9 million were net proceeds from our follow-on offering in December 2020, $9.3 million were net proceeds from borrowings under the Loan Agreement, $58.9 million were net proceeds from our follow-on offering in October 2023, and $29.3 million were net proceeds from our ATM offering.

Previous wording

We have incurred net losses in each year since inception. Our net losses were $39.4 million and $34.2 million for the three months ended June 30, 2024 and 2023, respectively. As of June 30, 2024, we had an accumulated deficit of $561.3 million. Substantially all of our operating losses are a result of expenses incurred in connection with our research and development programs, primarily evorpacept, and from general and administrative expenses associated with our operations.

Current wording

We have incurred net losses in each year since inception. Our net losses were $30.7 million and $51.0 million for the three months ended September 30, 2024 and 2023, respectively. As of September 30, 2024, we had an accumulated deficit of $592.0 million. Substantially all of our operating losses are a result of expenses incurred in connection with our research and development programs, primarily evorpacept, and from general and administrative expenses associated with our operations.

Previous wording

The following table summarizes our results of operations for the three months and six months ended June 30, 2024 and 2023 (in thousands):

Current wording

The following table summarizes our results of operations for the three months and nine months ended September 30, 2024 and 2023 (in thousands):

Previous wording

The following table summarizes our research and development (R&D) expenses incurred for the three months and six months ended June 30, 2024 and 2023 (in thousands):

Current wording

The following table summarizes our research and development (R&D) expenses incurred for the three months and nine months ended September 30, 2024 and 2023 (in thousands):

Previous wording

R&D expenses increased by $5.2 million during the three months ended June 30, 2024 compared to the three months ended June 30, 2023. The increase was primarily attributable to (i) an increase of $1.7 million in preclinical costs for development of new targets, (ii) an increase of $1.2 million in personnel and related costs primarily driven by headcount growth, (iii) an increase of $1.8 million in stock-based compensation expense of which $1.2 million was due to a change in classification from the comparative periods of stock-based compensation from G&A to R&D as a result of the change in roles for our former Chief Executive Officer who transitioned to Chief Scientific Officer in September 2023 and the remaining amount was due to additional awards granted since June 30, 2023, and (iv) an increase of $0.7 million in other research costs primarily due to absence of VAT refunds in the current quarter compared to prior year quarter. These increases were offset by a decrease of $0.3 million in clinical and development costs primarily due to reaching the Jazz Collaboration agreement maximum spending limit.

Current wording

R&D expenses decreased by $19.3 million during the three months ended September 30, 2024 compared to the three months ended September 30, 2023. The decrease was primarily attributable to a decrease of $22.2 million in clinical and development costs primarily due to manufacturing of clinical trial materials, the majority of which was completed in early 2024, to support active clinical trials for our lead product candidate, evorpacept. This decrease was offset by (i) an increase of $0.8 million in preclinical costs for development of new targets, (ii) an increase of $1.0 million in personnel and related costs primarily driven by headcount growth, (iii) an increase of $0.9 million in stock-based compensation expense due to additional awards granted since September 30, 2023, and (iv) an increase of $0.1 million in other research costs.

Previous wording

Research and development expenses increased by $12.1 million during the six months ended June 30, 2024 compared to the six months ended June 30, 2023. The increase was primarily attributable to (i) an increase of $2.5 million in clinical and development costs primarily due to $3.5 million in clinical costs from an increase in the number of active trials and patient enrollment as well as manufacturing of clinical trial materials to support a higher number of active clinical trials and future expected patient enrollment related to the advancement of our lead product candidate, evorpacept, offset by a decrease of $0.6 million related to reaching the maximum spending limit under the Jazz Collaboration and a decrease of $0.3 million related to the Tallac Collaboration for costs related to the IND filing, for which the primary work was completed in the prior years, (ii) an increase of $1.6 million in preclinical costs for development of new targets, (iii) an increase of $2.2 million in personnel and related costs due primarily to an increase driven by headcount growth, (iv) an increase of $3.6 million in stock-based compensation expense of which $2.3 million was due to a change in classification from the comparative periods of stock-based compensation from G&A to R&D as a result of the change in roles for our former Chief Executive Officer who transitioned to Chief Scientific Officer in September 2023 and the remaining amount was due to additional awards granted since June 30, 2023, and (v) an increase of $2.1 million in other research costs of which $1.0 million was due to a development milestone payment to ScalmiBio stockholders and of which $0.7 million was due to VAT refunds received in prior year that were not present in the current year.

Current wording

Research and development expenses decreased by $7.2 million during the nine months ended September 30, 2024 compared to the nine months ended September 30, 2023. The decrease was primarily attributable to a decrease of $19.6 million in clinical and development costs primarily due to manufacturing of clinical trial materials, the majority of which was completed in early 2024, to support active clinical trials for our lead product candidate, evorpacept. This decrease was offset by (i) an increase of $2.5 million in preclinical costs for development of new targets, (ii) an increase of $3.3 million in personnel and related costs due primarily to an increase driven by headcount growth, (iii) an increase of $4.5 million in stock-based compensation expense of which $2.4 million was due to a change in classification from the comparative periods of stock-based compensation from G&A to R&D as a result of the change in roles for our former Chief Executive Officer who transitioned to Chief Scientific Officer in September 2023 and the remaining amount was due to additional awards granted since September 30, 2023, and (iv) an increase of $2.2 million in other research costs of which $1.0 million was due to a development milestone payment to ScalmiBio stockholders and of which $0.6 million was due to VAT refunds received in prior year that were not present in the current year.

Previous wording

The following table summarizes our general and administrative (G&A) expenses incurred for the three months and six months ended June 30, 2024 and 2023 (in thousands):

Current wording

The following table summarizes our general and administrative (G&A) expenses incurred for the three months and nine months ended September 30, 2024 and 2023 (in thousands):

Previous wording

G&A expenses decreased by $0.4 million during the three months ended June 30, 2024 compared to the three months ended June 30, 2023. The decrease was primarily attributable to a decrease of $0.8 million in stock-based compensation expense primarily due to a change in classification from the comparative periods of stock-based compensation from G&A to R&D as described above under R&D expenses, offset by an increase of $0.3 million in other G&A costs from accounting consulting costs and an increase of $0.1 million in personnel and related costs primarily driven by headcount growth.

Current wording

G&A expenses decreased by $1.4 million during the three months ended September 30, 2024 compared to the three months ended September 30, 2023. The decrease was primarily attributable to a decrease of $0.9 million in stock-based compensation expense primarily due to a change in classification from the comparative periods of stock-based compensation from G&A to R&D as described above under R&D expenses and a decrease of $0.4 million in other G&A costs from accounting consulting costs.

Previous wording

G&A expenses decreased by $1.8 million during the six months ended June 30, 2024 compared to the six months ended June 30, 2023. The decrease was primarily attributable to a decrease of $1.9 million in stock-based compensation expense primarily due to a change in classification from the comparative periods of stock-based compensation from G&A to R&D as described above under R&D expenses.

Current wording

G&A expenses decreased by $3.2 million during the nine months ended September 30, 2024 compared to the nine months ended September 30, 2023. The decrease was primarily attributable to a decrease of $2.9 million in stock-based compensation expense primarily due to a change in classification from the comparative periods of stock-based compensation from G&A to R&D as described above under R&D expenses and a decrease of $0.3 million in other G&A costs a reduction in corporate insurance due to lower premiums.

Previous wording

Interest income decreased by $0.1 million for the three months ended June 30, 2024 compared to the three months ended June 30, 2023. The decrease was primarily attributable to lower cash and investment balances during the three months ended June 30, 2024 as compared to the three months ended June 30, 2023.

Current wording

Interest income decreased by $0.4 million for the three months ended September 30, 2024 compared to the three months ended September 30, 2023 and by $0.2 million for the nine months ended September 30, 2024 compared to the nine months ended September 30, 2023. The decrease was primarily attributable to lower cash and investment balances during 2024 as compared to 2023.

Previous wording

Interest expense increased by $0.1 million for the three months ended June 30, 2024 compared to the three months ended June 30, 2023 and by $0.1 million for the six months ended June 30, 2024 compared to the six months ended June 30, 2023. The increases were primarily attributable to higher interest rates.

Current wording

Interest expense increased by $0.1 million for the three months ended September 30, 2024 compared to the three months ended September 30, 2023 and by $0.2 million for the nine months ended September 30, 2024 compared to the nine months ended September 30, 2023. The increases were primarily attributable to higher interest rates.

Previous wording

Other (expense) income, net decreased by $0.3 million for the three months ended June 30, 2024 compared to the three months ended June 30, 2023. The decrease was primarily attributable to absence in the current period of other income from an immaterial service contract, under which the Company provides R&D services for another company.

Current wording

Other income (expense), net remained flat for the three months ended September 30, 2024 compared to the three months ended September 30, 2023 and decreased by $0.4 million for the nine months ended September 30, 2024 compared to the nine months ended September 30, 2023. The decrease was primarily attributable to absence in the current period of other income from an immaterial service contract, under which the Company provides R&D services for another company.

Previous wording

Since our inception, we have incurred significant operating losses and have not generated any product revenue. We have not yet commercialized any of our product candidates and we do not expect to generate revenue from sales of any product candidates for several years, if at all, subject to regulatory and marketing approval of any of our product candidates. To date, we have funded our operations with proceeds from the sales of shares of our common stock and convertible preferred stock and borrowings under our term loan. As of June 30, 2024, we had cash, cash equivalents and short-term and long-term investments of $186.2 million.

Current wording

Since our inception, we have incurred significant operating losses and have not generated any product revenue. We have not yet commercialized any of our product candidates and we do not expect to generate revenue from sales of any product candidates for several years, if at all, subject to regulatory and marketing approval of any of our product candidates. To date, we have funded our operations with proceeds from the sales of shares of our common stock and convertible preferred stock and borrowings under our term loan. As of September 30, 2024, we had cash, cash equivalents and short-term and long-term investments of $162.6 million.

Previous wording

We have incurred losses and negative cash flows from operations since inception and anticipate that we will continue to incur net losses for the foreseeable future. As of June 30, 2024, we had an accumulated deficit of $561.3 million. We expect our expenses to increase substantially in connection with our ongoing activities, particularly as we advance the preclinical activities and clinical trials for our product candidates in development. In addition, we expect to incur additional costs associated with operating as a public company. Management recognizes the need to raise additional capital to fully implement its business plan. The timing and amount of such future capital requirements are difficult to forecast and will depend on many factors, including:

Current wording

We have incurred losses and negative cash flows from operations since inception and anticipate that we will continue to incur net losses for the foreseeable future. As of September 30, 2024, we had an accumulated deficit of $592.0 million. We expect our expenses to increase substantially in connection with our ongoing activities, particularly as we advance the preclinical activities and clinical trials for our product candidates in development. In addition, we expect to incur additional costs associated with operating as a public company. Management recognizes the need to raise additional capital to fully implement its business plan. The timing and amount of such future capital requirements are difficult to forecast and will depend on many factors, including:

Previous wording

In December 2021, we entered into the Sales Agreement with Cantor Fitzgerald & Co. and Credit Suisse Securities (USA) LLC, under which we may offer and sell our common stock, having aggregate gross proceeds of up to $150.0 million, from time to time through them as our sales agents in our ATM offering program. In March 2022, we filed a Shelf Registration Statement with the SEC. In May 2022, we filed an amended Shelf Registration Statement, which was declared effective by the SEC on May 31, 2022. In August 2023, we entered into an amendment to the Sales Agreement to include UBS Securities LLC as an additional sales agent and to remove Credit Suisse as a sales agent. As of June 30, 2024, we sold an aggregate of 2,005,910 shares of common stock under our Sales Agreement for net proceeds of $29.2 million, after deducting commissions. We may terminate this ATM program and the Sales Agreement at any time, pursuant to its terms.

Current wording

In December 2021, we entered into the Sales Agreement with Cantor Fitzgerald & Co. and Credit Suisse Securities (USA) LLC, under which we may offer and sell our common stock, having aggregate gross proceeds of up to $150.0 million, from time to time through them as our sales agents in our ATM offering program. In March 2022, we filed a Shelf Registration Statement with the SEC. In May 2022, we filed an amended Shelf Registration Statement, which was declared effective by the SEC on May 31, 2022. In August 2023, we entered into an amendment to the Sales Agreement to include UBS Securities LLC as an additional sales agent and to remove Credit Suisse as a sales agent. As of September 30, 2024, we sold an aggregate of 2,005,910 shares of common stock under our Sales Agreement for net proceeds of $29.3 million, after deducting commissions. We may terminate this ATM program and the Sales Agreement at any time, pursuant to its terms.

Previous wording

The following table presents a summary of the net cash flow activity for the six months ended June 30, 2024 and 2023 (in thousands):

Current wording

The following table presents a summary of the net cash flow activity for the nine months ended September 30, 2024 and 2023 (in thousands):

Previous wording

In the six months ended June 30, 2023, net cash used in operating activities of $59.5 million was attributable to a net loss of $64.3 million and a change in net operating assets and liabilities of $6.2 million, offset by non-cash charges of $11.0 million. The change in operating assets and liabilities was primarily due to (i) a decrease in accounts payable and accrued expenses and other current liabilities of $7.1 million primarily due to timing of invoices and payments, (ii) a decrease in other assets of $3.4 million, (iii) an increase in prepaid and other current assets of $2.0 million and (iv) a decrease in other non-current liabilities of $0.5 million. Non-cash charges consisted primarily of stock-based compensation expense of $12.6 million and non-cash lease costs of $0.6 million offset by net amortization of premiums and accretion of discounts on investments of $2.8 million.

Current wording

In the nine months ended September 30, 2024, net cash used in operating activities of $89.9 million was attributable to a net loss of $105.7 million and a change in our net operating assets and liabilities of $3.7 million, offset by non-cash charges of $19.5 million. The change in operating assets and liabilities was primarily due to (i) a decrease in accounts payable and accrued expenses and other current liabilities of $2.8 million primarily due to timing of invoices and payments, (ii) a decrease in other assets of $2.2 million, (iii) an increase in prepaid and other current assets of $1.4 million and (iv) a decrease in other non-current liabilities of $1.6 million. Non-cash charges consisted primarily of stock-based compensation expense of $21.2 million, non-cash lease costs of $1.3 million, and depreciation and amortization costs of $0.7 million offset by net amortization of premiums and accretion of discounts on investments of $3.9 million.

Previous wording

In the six months ended June 30, 2024, net cash used in operating activities of $64.5 million was attributable to a net loss of $75.0 million and a change in our net operating assets and liabilities of $2.3 million, offset by non-cash charges of $12.8 million. The change in operating assets and liabilities was primarily due to (i) an increase in accounts payable and accrued expenses and other current liabilities of $2.9 million primarily due to timing of invoices and payments, (ii) a decrease in other assets of $1.9 million, (iii) an increase in prepaid and other current assets of $6.1 million and (iv) a decrease in other non-current liabilities of $1.1 million. Non-cash charges consisted primarily of stock-based compensation expense of $14.3 million, non-cash lease costs of $0.9 million, and depreciation and amortization costs of $0.4 million offset by net amortization of premiums and accretion of discounts on investments of $2.9 million.

Current wording

In the nine months ended September 30, 2023, net cash used in operating activities of $90.7 million was attributable to a net loss of $115.3 million, offset by a change in our net operating assets and liabilities of $8.0 million and non-cash charges of $16.7 million. The change in operating assets and liabilities was primarily due to (i) an increase in accounts payable and accrued expenses and other current liabilities of $10.0 million primarily due to timing of invoices and payments, (ii) a decrease in other assets of $4.2 million, (iii) an increase in prepaid and other current assets of $4.3 million and (iv) a decrease in other non-current liabilities of $2.0 million. Non-cash charges consisted primarily of stock-based compensation expense of $19.6 million, non-cash lease costs of $0.9 million, and depreciation and amortization costs of $0.6 million offset by net amortization of premiums and accretion of discounts on investments of $4.6 million.

Previous wording

In the six months ended June 30, 2024, net cash provided by investing activities of $27.4 million was attributable to cash received for maturities of investments of $121.9 million offset by purchases of short-term and long-term investments of $94.2 million and purchases of property and equipment of $0.2 million.

Current wording

In the nine months ended September 30, 2024, net cash provided by investing activities of $53.1 million was attributable to cash received for maturities of investments of $156.4 million offset by purchases of short-term and long-term investments of $103.0 million and purchases of property and equipment of $0.4 million.

Previous wording

In the six months ended June 30, 2023, net cash provided by investing activities of $48.5 million was attributable to cash received for maturities of investments of $169.7 million offset by purchases of short-term and long-term investments of $118.7 million and purchases of property and equipment of $2.4 million.

Current wording

In the nine months ended September 30, 2023, net cash provided by investing activities of $61.3 million was attributable to cash received for maturities of investments of $234.1 million offset by purchases of short-term and long-term investments of $171.6 million and purchases of property and equipment of $1.1 million.

Previous wording

In the six months ended June 30, 2024, net cash provided by financing activities of $30.2 million was attributable to proceeds from our ATM offering program of $29.2 million, proceeds from the exercise of stock options under equity incentive plans of $1.1 million, and proceeds from issuance of common stock pursuant to employee stock purchase plan of $0.3 million, offset by principal payments on finance leases of $0.4 million.

Current wording

In the nine months ended September 30, 2024, net cash provided by financing activities of $30.5 million was attributable to proceeds from our ATM offering program of $29.3 million, proceeds from the exercise of stock options under equity incentive plans of $1.6 million, and proceeds from issuance of common stock pursuant to employee stock purchase plan of $0.3 million, offset by principal payments on finance leases of $0.8 million.

Previous wording

In the six months ended June 30, 2023, net cash provided by financing activities was $0.2 million, attributable to proceeds from the exercise of stock options under equity incentive plans of $0.1 million and proceeds from issuance of common stock pursuant to employee stock purchase plan of $0.3 million and by principal payments on finance leases of $0.2 million.

Current wording

In the nine months ended September 30, 2023, net cash provided by financing activities of $0.1 million was attributable to proceeds from the exercise of stock options under equity incentive plans of $0.1 million and proceeds from issuance of common stock pursuant to employee stock purchase plan of $0.3 million and by principal payments on finance leases of $0.3 million.

Previous wording

Our significant accounting policies and critical accounting estimates are more fully described in the notes to our audited consolidated financial statements and in the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Estimates,” respectively, in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023. During the six months ended June 30, 2024, there were no material changes to our critical accounting policies and estimates from those discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023 filed with the SEC on March 7, 2024.

Current wording

Our significant accounting policies and critical accounting estimates are more fully described in the notes to our audited consolidated financial statements and in the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Estimates,” respectively, in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023. During the nine months ended September 30, 2024, there were no material changes to our critical accounting policies and estimates from those discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023 filed with the SEC on March 7, 2024.