QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) |
Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered | ||
Large accelerated filer | ☐ | Accelerated filer | ☐ | |||
Non-accelerated filer |
☒ | Smaller reporting company | ||||
Emerging growth company |
Artiva Biotherapeutics, Inc.
Table of Contents
3
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains forward-looking statements about us and our industry that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this Quarterly Report on Form 10-Q, including statements regarding future events, our business strategy, and the plans and objectives of management for future operations, are forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections. In some cases, you can identify forward-looking statements because they contain words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would,” or the negative of these words or other similar terms or expressions.
These statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Forward-looking statements include, but are not limited to, statements about:
• | the success, cost, timing and potential indications of our product development activities and clinical trials, including the ongoing clinical trials of AlloNK; |
• | the timing of our planned Investigational New Drug application (IND) submissions to the United States Food and Drug Administration (FDA) for our product candidates, including AlloNK; |
• | the timing of the initiation, enrollment and completion of planned clinical trials; |
• | the ability to obtain regulatory approval for our manufacturing facility in San Diego, California and the cost and timing associated therewith; |
• | our ability to obtain and maintain regulatory approval of our product candidates, including AlloNK, in any of the indications for which we plan to develop them, and any related restrictions, limitations and/or warnings in the label of an approved product candidate; |
• | our ability to obtain funding for our operations, including funding necessary to complete the clinical trials of any of our product candidates, including AlloNK; |
• | our plans to research and develop our product candidates, including AlloNK; |
• | our ability to attract and retain collaborators with development, regulatory and commercialization expertise; |
• | the size of the markets for our product candidates, and our ability to serve those markets; |
• | our ability to successfully commercialize our product candidates, including AlloNK; |
• | the rate and degree of market acceptance of our product candidates, including AlloNK; |
• | our ability to develop and maintain sales and marketing capabilities, whether alone or with potential future collaborators; |
• | the performance of our third-party suppliers and manufacturers; |
• | the success of competing therapies that are or become available; |
• | existing regulations and regulatory developments in the United States and other jurisdictions; |
• | the implementation of our business model and strategic plans for our business and operations; |
• | our ability to attract and retain key scientific or management personnel; |
• | the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for additional financing; |
• | our expectations regarding the impact of global health pandemics, geopolitical conflicts and economic uncertainty, including rising interest rates and inflation on our business and operations, including clinical trials, collaborators, contract research organizations (CROs) and employees; |
• | our expectations regarding the period during which we will qualify as an emerging growth company under the Jumpstart Our Business Startups Act (JOBS Act); and |
• | our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates and our ability to operate our business without infringing on the intellectual property rights of others. |
4
These forward-looking statements reflect our management’s beliefs and views with respect to future events and are based on estimates and assumptions as of the date of this Quarterly Report on Form 10-Q and are subject to risks and uncertainties. In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this Quarterly Report on Form 10-Q, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and investors are cautioned not to unduly rely upon these statements. We discuss many of the risks associated with the forward-looking statements in greater detail under the heading “Risk Factors” and elsewhere in this Quarterly Report on Form 10-Q. Moreover, we operate in a very competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Except as required by law, we undertake no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in any forward-looking statements, whether as a result of new information, future events or otherwise.
We may use our website as a means of disclosing material non-public information and for complying with our disclosure obligations under Regulation Fair Disclosure promulgated by the U.S. Securities and Exchange Commission. These disclosures will be included on our website under the “Investors” section.
5
AS OF |
||||||||
JUNE 30, 2024 |
DECEMBER 31, 2023 |
|||||||
Assets |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | $ | ||||||
Short-term investments |
||||||||
Accounts receivable (including related party amounts of $ |
||||||||
Other receivables (including related party amounts of $ |
||||||||
Prepaid expenses and other current assets |
||||||||
|
|
|
|
|||||
Total current assets |
||||||||
Restricted cash |
||||||||
Property and equipment, net |
||||||||
Operating lease right-of-use |
||||||||
Financing lease right-of-use |
— | |||||||
Deferred offering costs |
— | |||||||
Other long-term assets |
||||||||
|
|
|
|
|||||
Total assets |
$ | $ | ||||||
|
|
|
|
|||||
Liabilities, convertible preferred stock, and stockholders’ deficit |
||||||||
Current liabilities: |
||||||||
Accounts payable (including related party amounts of $ |
$ | $ | ||||||
Accrued expenses (including related party amounts of $ |
||||||||
Current portion of operating lease liabilities |
||||||||
Current portion of financing lease liability |
— | |||||||
|
|
|
|
|||||
Total current liabilities |
||||||||
Operating lease liabilities, net of current portion |
||||||||
Financing lease liability, net of current portion |
— | |||||||
Simple agreements for future equity (“SAFEs”) (including related party amounts of $ |
||||||||
Other non-current liabilities |
||||||||
|
|
|
|
|||||
Total liabilities |
||||||||
Commitments and contingencies (Note 11) |
||||||||
Series A convertible preferred stock, $ |
||||||||
Series B convertible preferred stock, $ |
||||||||
Stockholders’ deficit: |
||||||||
Common stock, $ |
||||||||
Additional paid-in capital |
||||||||
Accumulated other comprehensive income |
||||||||
Accumulated deficit |
( |
) | ( |
) | ||||
|
|
|
|
|||||
Total stockholders’ deficit |
( |
) | ( |
) | ||||
|
|
|
|
|||||
Total liabilities, convertible preferred stock and stockholders’ deficit |
$ | $ | ||||||
|
|
|
|
THREE MONTHS ENDED JUNE 30, |
SIX MONTHS ENDED JUNE 30, |
|||||||||||||||
2024 |
2023 |
2024 |
2023 |
|||||||||||||
Revenue: |
||||||||||||||||
Collaboration revenue |
$ | — | $ | $ | — | $ | ||||||||||
License and development support revenue (including related party amounts of $ $ |
— | — | — | |||||||||||||
Total revenue |
— | |||||||||||||||
Operating expenses: |
||||||||||||||||
Research and development (including related party amounts of $ , respectively) |
||||||||||||||||
General and administrative |
||||||||||||||||
Total operating expenses |
||||||||||||||||
Loss from operations |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
Other income (expense), net: |
||||||||||||||||
Interest income |
||||||||||||||||
Change in fair value of SAFEs (including related party amounts of $ |
( |
) | — | ( |
) | — | ||||||||||
Other income (expense), net |
( |
) | ||||||||||||||
Total other income (expense), net |
( |
) | ( |
) | ||||||||||||
Net loss |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
Net loss per share, basic and diluted |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
Weighted-average common shares outstanding, basic and diluted |
||||||||||||||||
Comprehensive loss: |
||||||||||||||||
Net loss |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
Other comprehensive income (loss): |
||||||||||||||||
Unrealized gain ( loss) on short-term investments |
( |
) | ( |
) | ||||||||||||
Comprehensive loss |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
SERIES A CONVERTIBLE PREFERRED STOCK |
SERIES B CONVERTIBLE PREFERRED STOCK |
COMMON STOCK |
ADDITIONAL PAID-IN CAPITAL |
ACCUMULATED OTHER COMPREHENSIVE INCOME |
ACCUMULATED DEFICIT |
TOTAL STOCKHOLDERS’ DEFICIT |
||||||||||||||||||||||||||||||||||
SHARES |
AMOUNT |
SHARES |
AMOUNT |
SHARES |
AMOUNT |
|||||||||||||||||||||||||||||||||||
Balance at December 31, 2022 |
$ |
$ |
$ |
— |
$ |
$ |
— |
$ |
( |
) |
$ |
( |
) | |||||||||||||||||||||||||||
Vesting of shares of common stock subject to repurchase, including early exercise |
— | — | — | — | — | — | ||||||||||||||||||||||||||||||||||
Stock-based compensation expense |
— | — | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||
Net loss |
— | — | — | — | — | — | — | — | ( |
) | ( |
) | ||||||||||||||||||||||||||||
Balance at March 31, 2023 |
$ |
$ |
— |
$ |
$ |
— |
$ |
( |
) |
$ |
( |
) | ||||||||||||||||||||||||||||
Exercise of stock options |
— | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||
Vesting of shares of common stock subject to repurchase, including early exercise |
— | — | — | — | — | — | ||||||||||||||||||||||||||||||||||
Stock-based compensation expense |
— | — | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||
Unrealized gain on short-term investments |
— | — | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||
Net loss |
— | — | — | — | — | — | — | — | ( |
) | ( |
) | ||||||||||||||||||||||||||||
Balance at June 30, 2023 |
$ |
$ |
$ |
— |
$ |
$ |
$ |
( |
) |
$ |
( |
) | ||||||||||||||||||||||||||||
Balance at December 31, 2023 |
$ |
$ |
$ |
— |
$ |
$ |
$ |
( |
) |
$ |
( |
) | ||||||||||||||||||||||||||||
Stock-based compensation expense investments |
— | — | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||
Unrealized loss on short-term investments |
— | — | — | — | — | — | — | ( |
) | — | ( |
) | ||||||||||||||||||||||||||||
Net loss |
— | — | — | — | — | — | — | — | ( |
) | ( |
) | ||||||||||||||||||||||||||||
Balance at March 31, 2024 |
$ |
$ |
$ |
— |
$ |
$ |
$ |
( |
) |
$ |
( |
) | ||||||||||||||||||||||||||||
Exercise of stock options |
— | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||
Stock-based compensation expense |
— | — | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||
Unrealized loss on short-term investments |
— | — | — | — | — | — | — | ( |
) | — | ( |
) | ||||||||||||||||||||||||||||
Net loss |
— | — | — | — | — | — | — | — | ( |
) | ( |
) | ||||||||||||||||||||||||||||
Balance at June 30, 2024 |
$ |
$ |
$ |
— |
$ |
$ |
$ |
( |
) |
$ |
( |
) | ||||||||||||||||||||||||||||
SIX MONTHS ENDED JUNE 30, |
||||||||
2024 |
2023 |
|||||||
Operating activities: |
||||||||
Net loss |
$ | ( |
) | $ | ( |
) | ||
Adjustments to reconcile net loss to cash used in operating activities: |
||||||||
Depreciation and amortization |
||||||||
Stock-based compensation |
||||||||
Change in fair value of SAFEs (including related party amounts of $ |
||||||||
Accretion of discounts on short-term investments |
( |
) | ( |
) | ||||
Changes in operating assets and liabilities: |
||||||||
Accounts receivable |
( |
) | ||||||
Other receivables (including related party amounts of $( |
( |
) | ( |
) | ||||
Prepaid expenses and other current assets |
( |
) | ||||||
Other long-term assets |
||||||||
Accounts payable (including related party amounts of $ |
( |
) | ( |
) | ||||
Accrued expenses (including related party amounts of $( |
( |
) | ( |
) | ||||
Operating lease right-of-use |
||||||||
Deferred revenue |
( |
) | ||||||
|
|
|
|
|||||
Net cash used in operating activities |
( |
) | ( |
) | ||||
|
|
|
|
|||||
Investing activities: |
||||||||
Purchases of property and equipment |
( |
) | ( |
) | ||||
Purchases of short-term investments |
( |
) | ( |
) | ||||
Maturities of short-term investments |
||||||||
|
|
|
|
|||||
Net cash provided by (used in) investing activities |
( |
) | ||||||
|
|
|
|
|||||
Financing activities: |
||||||||
Proceeds from exercise of stock options |
||||||||
Payments on finance leases |
( |
) | ||||||
Cash paid in connection with deferred offering costs |
( |
) | ||||||
Repurchase of restricted stock |
( |
) | ||||||
|
|
|
|
|||||
Net cash used in financing activities |
( |
) | ( |
) | ||||
|
|
|
|
|||||
Net decrease in cash, cash equivalents and restricted cash |
( |
) | ( |
) | ||||
|
|
|
|
|||||
Cash, cash equivalents and restricted cash at beginning of period |
||||||||
Cash, cash equivalents and restricted cash at end of period |
$ | $ | ||||||
|
|
|
|
|||||
Reconciliation of cash, cash equivalents and restricted cash to the balance sheet Cash and cash equivalents |
$ | $ | ||||||
Restricted cash |
||||||||
|
|
|
|
|||||
Total cash, cash equivalents and restricted cash |
$ | $ | ||||||
|
|
|
|
|||||
Supplemental disclosures of noncash activities: |
||||||||
Property and equipment purchases in accounts payable and accrued liabilities |
$ | $ | ||||||
|
|
|
|
|||||
Deferred offering costs in accounts payable and accrued liabilities |
$ | $ | ||||||
|
|
|
|
|||||
Non-cash additions to financing leases |
$ | $ | ||||||
|
|
|
|
AS OF JUNE 30, |
AS OF DECEMBER 31, |
|||||||
2024 |
2023 |
|||||||
Convertible preferred stock |
||||||||
Unvested restricted stock units |
||||||||
Options to purchase common stock |
||||||||
SAFEs (1) |
||||||||
Total |
||||||||
(1) | The contingently convertible SAFEs were not included for purposes of calculating the number of diluted shares outstanding as of June 30, 2024, as the number of dilutive shares is based on a conversion ratio associated with the pricing of a future financing or liquidation event. Therefore, the contingently convertible SAFEs’ conversion ratio, and the resulting number of dilutive shares, is not determinable until the contingency is resolved. If the contingency were to have been resolved as of June 30, 2024, the number of anti-dilutive shares that would have been excluded in the calculation of dilutive net loss per share, when applying the respective conversion ratio, is estimated as |
AS OF JUNE 30, 2024 |
||||||||||||||||||
CLASSIFICATION |
TOTAL |
LEVEL 1 |
LEVEL 2 |
LEVEL 3 |
||||||||||||||
Assets |
||||||||||||||||||
Money market funds |
Cash and cash equivalents | $ | $ | $ | — | $ | — | |||||||||||
Government and government agency bonds |
Short-term investments | — | — | |||||||||||||||
Total assets |
$ | $ | $ | $ | — | |||||||||||||
Liabilities |
||||||||||||||||||
SAFEs |
Liabilities | $ | $ | — | $ | — | $ | |||||||||||
Total liabilities |
$ | $ | — | $ | — | $ | ||||||||||||
AS OF DECEMBER 31, 2023 |
||||||||||||||||||
CLASSIFICATION |
TOTAL |
LEVEL 1 |
LEVEL 2 |
LEVEL 3 |
||||||||||||||
Assets |
||||||||||||||||||
Money market funds |
Cash and cash equivalents | $ | $ | $ | — | $ | — | |||||||||||
Commercial paper |
Short-term investments | — | — | |||||||||||||||
Government and government agency bonds |
Short-term investments | — | — | |||||||||||||||
Corporate bonds |
Short-term investments | — | — | |||||||||||||||
Total assets |
$ | $ | $ | $ | — | |||||||||||||
Liabilities |
||||||||||||||||||
SAFEs |
Liabilities | $ | $ | — | $ | — | $ | |||||||||||
Total liabilities |
$ | $ | — | $ | — | $ | ||||||||||||
VALUATION TECHNIQUE |
UNOBSERVABLE INPUT |
AS OF JUNE 30, 2024 |
||||||||||
Liabilities |
||||||||||||
SAFEs |
Scenario-based approach |
Probability weighting | % | |||||||||
Discount rate | % | |||||||||||
Remaining term to event (in years) |
VALUATION TECHNIQUE |
UNOBSERVABLE INPUT |
AS OF DECEMBER 31, 2023 |
||||||||||
Liabilities |
||||||||||||
SAFEs |
Scenario-based approach |
Probability weighting | % | |||||||||
Discount rate | % | |||||||||||
Remaining term to event (in years) |
SAFEs |
||||
Balance at December 31, 2023 |
$ | |||
Changes in fair value of SAFEs |
||||
|
|
|||
Balance at June 30, 2024 |
$ | |||
|
|
AS OF JUNE 30, 2024 |
||||||||||||||||||
CLASSIFICATION |
AMORTIZED COST |
GROSS UNREALIZED GAINS |
GROSS UNREALIZED LOSSES |
FAIR MARKET VALU E |
||||||||||||||
Cash and money market funds |
Cash and cash equivalents | $ | $ | — | $ | — | $ | |||||||||||
Government and government agency bonds |
Short-term investments | — | ||||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||
Total cash, cash equivalents and short-term investments |
$ | $ | $ | — | $ | |||||||||||||
|
|
|
|
|
|
|
|
AS OF DECEMBER 31, 2023 |
||||||||||||||||||
CLASSIFICATION |
AMORTIZED COST |
GROSS UNREALIZED GAINS |
GROSS UNREALIZED LOSSES |
FAIR MARKET VALUE |
||||||||||||||
Cash and money market funds |
Cash and cash equivalents | $ | $ | — | $ | — | $ | |||||||||||
Commercial paper |
Short-term investments | — | ||||||||||||||||
Government and government agency bonds |
Short-term investments | — | ||||||||||||||||
Corporate bonds |
Short-term investments | — | ||||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||
Total cash, cash equivalents and short-term investments |
$ | $ | $ | — | $ | |||||||||||||
|
|
|
|
|
|
|
|
AS OF |
||||||||
JUNE 30, |
DECEMBER 31, |
|||||||
2024 |
2023 |
|||||||
Lab equipment |
$ | $ | ||||||
Furniture and fixtures |
|
|||||||
Computers and software |
||||||||
Leasehold improvements |
||||||||
Less accumulated depreciation |
( |
) | ( |
) | ||||
Total property and equipment, net |
$ | $ | ||||||
AS OF |
||||||||
JUNE 30, |
DECEMBER 31, |
|||||||
2024 |
2023 |
|||||||
Accrued research and development expenses |
$ | $ | ||||||
Accrued payroll and other employee benefits |
|
|||||||
Other accrued expenses |
||||||||
Total accrued expenses |
$ | $ | ||||||
AS OF |
||||||||
JUNE 30, 2024 |
DECEMBER 31, 2023 |
|||||||
Convertible preferred stock |
||||||||
Common stock options granted and outstanding |
||||||||
Restricted stock units granted and outstanding |
|
|||||||
Shares available for issuance under the 2020 equity incentive plan |
||||||||
Shares available for issuance under the Pledge 1% commitment |
||||||||
Total common stock reserved for future issuance |
||||||||
TOTAL OPTIONS |
WEIGHTED- AVERAGE EXERCISE PRICE PER SHARE |
WEIGHTED- AVERAGE REMAINING CONTRACTUAL TERM |
AGGREGATE INTRINSIC VALUE |
|||||||||||||
(in years) |
(in thousands) |
|||||||||||||||
Outstanding at December 31, 2023 |
$ | $ | ||||||||||||||
Granted |
— |
— | ||||||||||||||
Exercised |
( |
) | — |
— | ||||||||||||
Cancelled |
( |
) | — |
— | ||||||||||||
Outstanding at June 30, 2024 |
$ | $ | ||||||||||||||
Exercisable as of June 30, 2024 |
$ | $ | ||||||||||||||
THREE MONTHS ENDED JUNE 30, |
SIX MONTHS ENDED JUNE 30, |
|||||||||||||||
2024 |
2023 |
2024 |
2023 |
|||||||||||||
Research and development |
$ | $ | $ | $ | ||||||||||||
General and administrative |
||||||||||||||||
Total |
$ | $ | $ | $ | ||||||||||||
SIX MONTHS ENDED JUNE 30, |
||||||||
2024 |
2023 |
|||||||
Stock price |
$ | $ | ||||||
Risk-free rate of interest |
% | % | ||||||
Expected term (years) |
||||||||
Expected stock price volatility |
% | % | ||||||
Expected dividend yield |
— | — |
THREE MONTHS ENDED JUNE 30, |
SIX MONTHS ENDED JUNE 30, |
|||||||||||||||
2024 |
2023 |
2024 |
2023 |
|||||||||||||
Rent expense |
$ | $ | $ | $ | ||||||||||||
Amount of rent expense related to short-term leases |
PERIOD ENDED JUNE 30, |
||||
2024 (remaining) |
||||
2025 |
||||
2026 |
||||
2027 |
||||
Thereafter |
||||
Total minimum lease payments |
||||
Less: amount representing interest |
( |
) | ||
Present value of operating lease liabilities |
||||
Less: operating lease liabilities, current |
( |
) | ||
Operating lease liabilities, net of current portion |
$ | |||
AS OF |
||||||||
JUNE 30, |
DECEMBER 31, |
|||||||
2024 |
2023 |
|||||||
Weighted-average remaining lease term |
|
|||||||
Weighted-average discount rate |
% | % |
PERIOD ENDED JUNE 3 0 , |
||||
2024 (remaining) |
$ | |||
2025 |
||||
Total |
$ | |||
Item 2. | Management’s Discussion and Analysis of Financial Condition and Results of Operations |
MANAGEMENT’S DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion and analysis of our financial condition and results of operations and the unaudited interim condensed financial statements and related notes included in this Quarterly Report on Form 10-Q should be read in conjunction with the financial statements and related notes thereto as of and for the year ended December 31, 2023 and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations, both of which are contained in the prospectus filed on July 22, 2024, pursuant to Rule 424(b) under the Securities Act of 1933, as amended (the Securities Act), with the Securities and Exchange Commission (the SEC) , or the Prospectus. This discussion and analysis and other parts of this Quarterly Report on Form 10-Q contain forward-looking statements based upon current beliefs, plans and expectations related to future events and our future financial performance that involve risks, uncertainties and assumptions, such as statements regarding our intentions, plans, objectives and expectations for our business. Our actual results and the timing of selected events could differ materially from those described in or implied by these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in the sections of this Quarterly Report on Form 10-Q entitled “Special Note Regarding Forward-Looking Statements” and “Risk Factor,” under Part II, Item 1A.
Overview
We are a clinical-stage biotechnology company focused on developing natural killer (NK) cell-based therapies for patients suffering from devastating autoimmune diseases and cancers. Our product candidates are derived from donor cells (allogeneic) rather than a patient’s own cells (autologous) and are pre-manufactured, stored frozen and ready to ship to a patient’s treatment location, making them what we believe to be “off-the-shelf.” Our lead product candidate, AlloNK, is a non-genetically modified, cryopreserved NK cell therapy being evaluated in combination with B-cell targeted monoclonal antibodies (mAbs) in an ongoing Phase 1/1b trial in systemic lupus erythematosus (SLE) with or without lupus nephritis (LN) and a basket investigator-initiated trial (IIT) in multiple autoimmune indications. Seminal peer-reviewed clinical studies using autologous CD19 chimeric antigen receptor (CAR) T-cell therapy (auto-CAR-T) for the treatment of autoimmune diseases have demonstrated that deep B-cell depletion in the periphery and in the lymphoid tissue can lead to drug free disease remission. We have already demonstrated that AlloNK in combination with rituximab was able to drive deep B-cell depletion in the periphery and observed complete responses (CRs) in heavily pre-treated patients naïve to auto-CAR-T in our ongoing Phase 1/2 clinical trial in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL). We believe the preliminary results from our Phase 1/2 clinical trial evaluating AlloNK in combination with rituximab in patients with B-NHL provide a readthrough to autoimmune disease because efficacy in both diseases appears to be accomplished with a shared mechanism of action involving B-cell depletion in the periphery and in the lymphoid tissues, followed by an immunological reset and B-cell reconstitution. We expect to report initial data on autoimmune indications from at least one of our Phase 1/1b trial or the basket IIT in the first half of 2025.
We commenced our operations in 2019 and have devoted substantially all of our resources to date to organizing and staffing our company, business planning, raising capital, establishing and engaging in collaborations, conducting research and development, advancing and scaling up product candidate manufacturing, establishing cold chain delivery logistics, establishing and protecting our intellectual property portfolio and providing general and administrative support for these activities. Our operations to date have been funded primarily through the issuance and sale of convertible promissory notes, convertible preferred stock, and simple agreements for future equity (SAFEs). From our inception through June 30, 2024, we have raised aggregate gross proceeds of $8.0 million from the issuance and sale of convertible promissory notes, $70.0 million from our Series A convertible preferred stock financings, $120.0 million from our Series B convertible preferred stock financing and $24.4 million from our SAFEs. Additionally, on July 22, 2024, we closed on our initial public offering (IPO), in which we issued and sold 13,920,000 shares of common stock at a public offering price of $12.00 per share. We also sold an additional 1,000,000 shares of common stock upon the partial exercise of the underwriters’ purchase option. The aggregate net proceeds of the IPO, inclusive of the partial exercise of the underwriters’ purchase option and after deducting underwriting discounts, commissions, and offering expenses, was $161.9 million.
We have incurred significant operating losses since the commencement of our operations. We have never generated any revenue from product sales and do not expect to generate any revenues from product sales unless and until we successfully complete development of and obtain regulatory approval for our product candidates, which will not be for several years, if ever. In addition, if we obtain regulatory approval for any of our product candidates, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution.
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We have incurred a net loss of $31.8 million and $28.0 million during the six months ended June 30, 2024 and 2023, respectively, and $28.7 million and $58.8 million during the years ended December 31, 2023 and 2022, respectively. As of June 30, 2024, we had an accumulated deficit of $213.1 million, and cash, cash equivalents and short term investments of $46.6 million. We expect to continue to incur significant losses for the foreseeable future as we advance our current and future product candidates through preclinical and clinical development, continue to build our operations and transition to operating as a public company. Accordingly, until such time as we can generate significant revenue from sales of our product candidates, if ever, we expect to finance our cash needs through public or private equity or debt financings or other capital sources, which may include our existing and any future strategic collaborations and other strategic arrangements with third parties. However, we may not be able to raise additional funds or enter into such other arrangements when needed or on favorable terms, or at all. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our stockholders will be or could be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Debt financing and equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through collaboration or licensing arrangements with third parties or other strategic transactions, we may have to relinquish rights to our intellectual property, future revenue streams, research programs, or product candidates or grant licenses on terms that may not be favorable