UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 24, 2024
Inhibrx Biosciences, Inc.
(Exact name of registrant as specified in its charter)
Delaware | 001-42031 | 99-0613523 |
(State or other jurisdiction of incorporation) | (Commission File Number) | (IRS Employer Identification No.) |
11025 N. Torrey Pines Road, Suite 140
La Jolla, CA 92037
(Address of principal executive offices, including zip code)
(858) 795-4220
(Registrant’s telephone number, including area code)
Not applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of each class | Trading symbol | Name of each exchange on which registered |
Common Stock, par value $0.0001 per share | INXB | The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company x
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. x
Item 7.01. Regulation FD Disclosure.
Inhibrx Biosciences, Inc., a Delaware corporation (the “Company”), previously filed with the U.S. Securities and Exchange Commission (the “SEC”) a registration statement on Form 10, as amended (the “Registration Statement”), relating to the distribution of 92% of the issued and outstanding shares of the Company’s common stock by Inhibrx, Inc. (“RemainCo”) to holders of shares of RemainCo’s common stock as of the distribution record date, on a pro rata basis (the “Distribution”), at a ratio of one share of the Company’s common stock for every four shares of RemainCo’s issued and outstanding common stock held on May 17, 2024, the distribution record date.
On May 24, 2024, the Registration Statement was declared effective by the SEC. The Registration Statement includes a preliminary information statement that describes the Distribution and provides important information regarding the Company’s business and management. The final information statement, dated May 24, 2024 (the “Information Statement”), is attached hereto as Exhibit 99.1.
As further described in the Information Statement, subject to the satisfaction or waiver of certain conditions, the Distribution is expected to be effective as of 11:59 p.m., New York City time, on May 29, 2024 (the “Distribution Time”), and the closing of the previously announced merger of RemainCo with and into a wholly owned indirect subsidiary of Sanofi (the “Merger”) is expected to occur on May 30, 2024, subject to the satisfaction or waiver of customary closing conditions.
Beginning on May 28, 2024 and through the Distribution Time, shares of the Company’s common stock are expected to begin trading on a “when-issued” basis on The Nasdaq Global Market (“Nasdaq”) under the symbol “INXBV”. On May 30, 2024, the first trading day following the consummation of the Distribution, shares of the Company’s common stock are expected to begin trading on a “regular-way” basis on Nasdaq under the symbol “INXB.” On May 31, 2024, the first trading day following the closing of the Merger, shares of the Company’s common stock are expected to begin trading on Nasdaq under the symbol “INBX”, which is currently the symbol for RemainCo’s shares of common stock.
The information furnished pursuant to this Item 7.01, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities under that Section and shall not be deemed to be incorporated by reference into any filing of the Company under the Securities Act of 1933 or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. |
Description |
99.1 | Information Statement of Inhibrx Biosciences, Inc., dated May 24, 2024. |
104 | The cover page of this Current Report on Form 8-K formatted as Inline XBRL. |
2
Cautionary Statement Regarding Forward-Looking Statements
This communication contains forward-looking statements about Sanofi’s proposed acquisition of RemainCo and INBRX-101, and RemainCo’s related spin-off of the assets and liabilities associated with INBRX-105, INBRX-106 and INBRX-109, its existing pipeline and corporate infrastructure, which involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Such risks and uncertainties include, among other things, risks related to the satisfaction or waiver of the conditions to closing the proposed acquisition (including the failure to obtain necessary regulatory approvals) in the anticipated timeframe or at all, including the possibility that the proposed acquisition does not close; the possibility that competing offers may be made; risks and costs relating to the separation of the assets and liabilities associated with INBRX-105, INBRX-106 and INBRX-109 and the consummation of the spin-off in the anticipated timeframe or at all; changes to the configuration of the INBRX-105, INBRX-106 and INBRX-109 businesses included in the separation if implemented; disruption from the transaction making it more difficult to maintain business and operational relationships; risks related to diverting management’s attention from the Company’s ongoing business operation; negative effects of this announcement or the consummation of the proposed transaction on the market price of the Company’s shares of common stock and/or operating results; significant transaction costs; risks associated with the discovery of unknown liabilities prior to or after the closing of the proposed transactions; the risk of litigation and/or regulatory actions related to the proposed transactions or the Company’s business; other business effects and uncertainties, including the effects of industry, market, business, economic, political or regulatory conditions; the conflicts in the Ukraine and the Middle East; future exchange and interest rates; changes in tax and other laws, regulations, rates and policies; and future business combinations or disposals. Important factors, risks and uncertainties that could cause actual results to differ materially from such forward looking statements also include but are not limited to the initiation, timing, progress and results of the Company’s research and development programs as well as the Company’s preclinical studies and clinical trials; the Company’s ability to advance therapeutic candidates into, and successfully complete, clinical trials; the Company’s interpretation of initial, interim or preliminary data from the Company’s clinical trials, including interpretations regarding disease control and disease response; the timing or likelihood of regulatory filings and approvals, including whether any product candidate, receives approval from the FDA, or similar regulatory authority, for an accelerated approval process; the commercialization of the Company’s therapeutic candidates, if approved; the pricing, coverage and reimbursement of the Company’s therapeutic candidates, if approved; the Company’s ability to utilize its technology platform to generate and advance additional therapeutic candidates; the implementation of the Company’s business model and strategic plans for the Company’s business and therapeutic candidates; the Company’s ability to successfully manufacture its therapeutic candidates for clinical trials and commercial use, if approved; the Company’s ability to contract with third-party suppliers and manufacturers and their ability to perform adequately; the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates; the Company’s ability to enter into strategic partnerships and the potential benefits of such partnerships; the Company’s estimates regarding expenses, capital requirements and needs for additional financing; the ability to raise funds needed to satisfy its capital requirements, which may depend on financial, economic and market conditions and other factors, over which the Company may have no or limited control; the Company’s financial performance; the Company’s and its third party partners’ and service providers’ ability to continue operations and advance the Company’s therapeutic candidates through clinical trials and the ability of the Company’s third party manufacturers to provide the required raw materials, antibodies and other biologics for the Company’s preclinical research and clinical trials in light of current market conditions or any pandemics, regional conflicts, sanctions, labor conditions, geopolitical events, natural disasters or extreme weather events; the ability to retain the continued service of the Company’s key professionals and to identify, hire and retain additional qualified professionals; and developments relating to the Company’s competitors and its industry; and other risks described from time to time in the “Risk Factors” section of its filings with the U.S. Securities and Exchange Commission, including those described in its Information Statement attached to this Current Report on Form 8-K. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and the Company undertakes no obligation to update these statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
3
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Date: May 24, 2024
INHIBRX BIOSCIENCES, INC. | ||
By: | /s/ Kelly Deck | |
Name: Kelly Deck | ||
Title: Chief Financial Officer and Treasurer |
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| | | | F-1 | | |
| | |
Pro Forma
|
| |
Historical
|
| ||||||||||||||||||||||||||||||
| | |
Three Months
Ended March 31, 2024 |
| |
Year Ended
December 31, 2023 |
| |
Three Months Ended
March 31, |
| |
Years Ended
December 31, |
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|
2024
|
| |
2023
|
| |
2023
|
| |
2022
|
| ||||||||||||||||||||||||||
| | |
(Unaudited)
|
| |
(Unaudited)
|
| | | | | | | | | | | | | ||||||||||||||||||
| | |
(In thousands, except per share amounts)
|
| |||||||||||||||||||||||||||||||||
Revenue: | | | | | | | | | | | | | | | | | | | | | | | |||||||||||||||
License fee revenue
|
| | | $ | — | | | | | $ | 1,634 | | | | | $ | — | | | | | $ | 17 | | | | | $ | 1,800 | | | | | $ | 2,178 | | |
Grant revenue
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 14 | | |
Total revenue
|
| | | | — | | | | | | 1,634 | | | | | | — | | | | | | 17 | | | | | | 1,800 | | | | | | 2,192 | | |
Operating expenses: | | | | | | | | | | | | | | | | | | | | | | | |||||||||||||||
Research and development
|
| | | | 43,898 | | | | | | 172,926 | | | | | | 63,851 | | | | | | 37,386 | | | | | | 191,640 | | | | | | 110,186 | | |
General and administrative
|
| | | | 9,606 | | | | | | 111,357 | | | | | | 9,974 | | | | | | 6,397 | | | | | | 29,381 | | | | | | 21,123 | | |
Total operating expenses
|
| | | | 53,504 | | | | | | 284,283 | | | | | | 73,825 | | | | | | 43,783 | | | | | | 221,021 | | | | | | 131,309 | | |
Loss from operations
|
| | | | (53,504) | | | | | | (282,649) | | | | | | (73,825) | | | | | | (43,766) | | | | | | (219,221) | | | | | | (129,117) | | |
Other income (expense): | | | | | | | | | | | | | | | | | | | | | | | |||||||||||||||
Interest income (expense), net
|
| | | | 3,304 | | | | | | 11,917 | | | | | | (4,826) | | | | | | (5,080) | | | | | | (19,923) | | | | | | (16,107) | | |
Other income (expense), net
|
| | | | (59) | | | | | | 1,690,020 | | | | | | (59) | | | | | | (70) | | | | | | (580) | | | | | | 1 | | |
Total other expense
|
| | | | 3,245 | | | | | | 1,701,937 | | | | | | (4,885) | | | | | | (5,150) | | | | | | (20,503) | | | | | | (16,106) | | |
Income (loss) before provision for income taxes
|
| | | | (50,259) | | | | | | 1,419,288 | | | | | | (78,710) | | | | | | (48,916) | | | | | | (239,724) | | | | | | (145,223) | | |
Provision for income taxes
|
| | | | 1,814 | | | | | | (17,774) | | | | | | — | | | | | | — | | | | | | 3 | | | | | | 3 | | |
Loss on equity method
investment |
| | | | — | | | | | | 1,634 | | | | | | — | | | | | | — | | | | | | 1,634 | | | | | | — | | |
Net income (loss)
|
| | | | (52,073) | | | | | | 1,435,428 | | | | | | (78,710) | | | | | | (48,916) | | | | | | (241,361) | | | | | | (145,226) | | |
Net loss per share, basic and diluted
|
| | | $ | (3.46) | | | | | $ | 98.64 | | | | | $ | (1.44) | | | | | $ | (1.12) | | | | | $ | (5.12) | | | | | $ | (3.62) | | |
Weighted-average shares of common stock outstanding, basic and diluted
|
| | | | 15,060 | | | | | | 14,553 | | | | | | 54,544 | | | | | | 43,575 | | | | | | 47,130 | | | | | | 40,108 | | |
| | |
Pro Forma
|
| |
Historical
|
| ||||||||||||||||||
| | |
As of March 31,
2024 |
| |
As of March 31,
2024 |
| |
As of December 31,
|
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2023
|
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2022
|
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| | |
(Unaudited)
|
| |
(Unaudited)
|
| | | | | | | | | | | | | ||||||
| | |
(In thousands)
|
| |||||||||||||||||||||
Cash and cash equivalents
|
| | | $ | 252,483 | | | | | $ | 252,483 | | | | | $ | 277,924 | | | | | $ | 273,865 | | |
Current portion of long-term debt, net of discount
|
| | | | — | | | | | | 3,632 | | | | | | — | | | | | | — | | |
Long-term debt, including final fee payment
|
| | | | — | | | | | | 204,578 | | | | | | 206,968 | | | | | | 202,069 | | |
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Jurisdiction
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Patent Number
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Expected
Expiration Date |
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Type
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Title
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US
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| | 10,526,397 | | | 2/24/2036 | | | Composition | | | NON-IMMUNOGENIC SINGLE DOMAIN ANTIBODIES | |
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AU
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| | 2016209247 | | | 2/7/2036 | | | Composition | | | NON-IMMUNOGENIC SINGLE DOMAIN ANTIBODIES | |
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JP
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| | 7001474 | | | 2/7/2036 | | | Composition | | | NON-IMMUNOGENIC SINGLE DOMAIN ANTIBODIES | |
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Jurisdiction
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Patent Number
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Expected
Expiration Date |
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Type
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Title
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US
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| | 10,308,720 | | | 7/18/2036 | | | Composition | | | MULTIVALENT AND MULTISPECIFIC DR5-BINDING FUSION PROTEINS | |
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US
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| | 11,117,973 | | | 11/22/2036 | | | Method | | | MULTIVALENT AND MULTISPECIFIC DR5-BINDING FUSION PROTEINS AND METHODS OF TREATING NEOPLASMS | |
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AU
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| | 2016291701 | | | 7/18/2036 | | | Composition and use | | | MULTIVALENT AND MULTISPECIFIC DR5-BINDING FUSION PROTEINS | |
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CN
|
| | ZL201680041274.2 | | | 7/18/2036 | | | Composition and use | | | MULTIVALENT AND MULTISPECIFIC DR5-BINDING FUSION PROTEINS | |
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EP (Validated in: AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LI, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR)
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| | 3322734 | | | 7/18/2036 | | | Composition and use | | | MULTIVALENT AND MULTISPECIFIC DR5-BINDING FUSION PROTEINS | |
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HK
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| | 1254433 | | | 7/18/2036 | | | Composition and use | | | MULTIVALENT AND MULTISPECIFIC DR5-BINDING FUSION PROTEINS | |
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Patent Number
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Expected
Expiration Date |
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Type
|
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Title
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ID
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| | P000075513 | | | 7/18/2036 | | | Composition and use | | | MULTIVALENT AND MULTISPECIFIC DR5-BINDING FUSION PROTEINS | |
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IL
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| | 256772 | | | 7/18/2036 | | | Composition and use | | | MULTIVALENT AND MULTISPECIFIC DR5-BINDING FUSION PROTEINS | |
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IN
|
| | 401979 | | | 7/18/2036 | | | Composition and use | | | MULTIVALENT AND MULTISPECIFIC DR5-BINDING FUSION PROTEINS | |
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JP
|
| | 6807606 | | | 7/18/2036 | | | Composition and method | | | MULTIVALENT AND MULTISPECIFIC DR5-BINDING FUSION PROTEINS | |
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JP
|
| | 7244938 | | | 7/18/2036 | | | Composition and method | | | MULTIVALENT AND MULTISPECIFIC DR5-BINDING FUSION PROTEINS | |
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MX
|
| | 400419 | | | 7/18/2036 | | | Composition and use | | | MULTIVALENT AND MULTISPECIFIC DR5-BINDING FUSION PROTEINS | |
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RU
|
| | 2748620 | | | 7/18/2036 | | | Composition and use | | | MULTIVALENT AND MULTISPECIFIC DR5-BINDING FUSION PROTEINS | |
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SG
|
| | 11201800223W | | | 7/18/2036 | | | Composition and use | | | MULTIVALENT AND MULTISPECIFIC DR5-BINDING FUSION PROTEINS | |
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ZA
|
| | 2018/00238 | | | 7/18/2036 | | | | | | MULTIVALENT AND MULTISPECIFIC DR5-BINDING FUSION PROTEINS | |
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US
|
| | 10,093,742 | | | 7/22/2036 | | | Composition and method | | | MULTIVALENT AND MULTISPECIFIC GITR-BINDING FUSION PROTEINS | |
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US
|
| | 10,844,129 | | | 7/22/2036 | | | Composition and method | | | MULTIVALENT AND MULTISPECIFIC GITR-BINDING FUSION PROTEINS | |
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AU
|
| | 2,016,297,249 | | | 7/22/2036 | | | Composition, method and use | | | MULTIVALENT AND MULTISPECIFIC GITR-BINDING FUSION PROTEINS | |
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Jurisdiction
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Patent Number
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Expected
Expiration Date |
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Type
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Title
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NZ
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| | 739130 | | | 7/22/2036 | | | Composition, method and use | | | MULTIVALENT AND MULTISPECIFIC GITR-BINDING FUSION PROTEINS | |
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US
|
| | 11,117,972 | | | 5/4/2037 | | | Composition | | | MULTIVALENT AND MULTISPECIFIC OX40- BINDING FUSION PROTEINS | |
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ID
|
| | P000085528 | | | 1/11/2037 | | | Composition | | | MULTIVALENT AND MULTISPECIFIC OX40- BINDING FUSION PROTEINS | |
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IL
|
| | 260531 | | | 1/11/2037 | | | Composition and use | | | MULTIVALENT AND MULTISPECIFIC OX40- BINDING FUSION PROTEINS | |
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JP
|
| | 7,328,761 | | | 1/11/2037 | | | Composition and use | | | MULTIVALENT AND MULTISPECIFIC OX40- BINDING FUSION PROTEINS | |
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RU
|
| | 2,773,052 | | | 7/22/2036 | | | Composition and use | | | MULTIVALENT AND MULTISPECIFIC OX40- BINDING FUSION PROTEINS | |
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US
|
| | 11,447,556 | | | 2/8/2040 | | | Composition | | | MULTIVALENT AND MULTISPECIFIC OX40- BINDING FUSION PROTEINS | |
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RU
|
| | 2,802,070 | | | 8/12/2039 | | | Composition, method and use | | | OX40-BINDING POLYPEPTIDES AND USES THEREOF | |
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US
|
| | 10,501,551 | | | 8/14/2037 | | | Composition and method | | | MULTIVALENT AND MULTISPECIFIC 41BB-BINDING FUSION PROTEINS | |
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US
|
| | 11,566,078 | | | 2/23/2038 | | | Composition | | | PDL1-BINDING PROTEINS (AS AMENDED) | |
|
AU
|
| | 2,017,207,742 | | | 1/11/2037 | | | Composition and method | | | MULTIVALENT AND MULTISPECIFIC 41BB-BINDING FUSION PROTEINS | |
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ID
|
| | P000089844 | | | 1/11/2037 | | | Composition method and use | | | MULTIVALENT AND MULTISPECIFIC 41BB-BINDING FUSION PROTEINS | |
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Jurisdiction
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Patent Number
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Expected
Expiration Date |
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Type
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Title
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IL
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| | 260530 | | | 1/11/2037 | | | Composition and use | | | MULTIVALENT AND MULTISPECIFIC 41BB-BINDING FUSION PROTEINS | |
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JP
|
| | 7,022,993 | | | 1/11/2037 | | | Composition and method | | | MULTIVALENT AND MULTISPECIFIC 41BB-BINDING FUSION PROTEINS | |
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RU
|
| | 2,789,648 | | | 1/11/2037 | | | Composition, method and use | | | MULTIVALENT AND MULTISPECIFIC 41BB-BINDING FUSION PROTEINS | |
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US
|
| | 11,434,297 | | | 12/24/2040 | | | Composition, method and use | | | CD123-BINDING POLYPEPTIDES AND USES THEREOF | |
|
US
|
| | 11,560,428 | | | 12/4/2040 | | | Composition and use | | | CD33-BINDING POLYPEPTIDES AND USES THEREOF | |
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ID
|
| | P000090304 | | | 12/4/2040 | | | Composition and use | | | CD33-BINDING POLYPEPTIDES AND USES THEREOF | |
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JP
|
| | 7,164,544 | | | 4/11/2038 | | | Composition, method and use | | | MULTISPECIFIC POLYPEPTIDE CONSTRUCTS HAVING CONSTRAINED CD3 BINDING AND METHODS OF USING THE SAME | |
|
NZ
|
| | 758264 | | | 4/11/2038 | | | Composition, method and use | | | MULTISPECIFIC POLYPEPTIDE CONSTRUCTS HAVING CONSTRAINED CD3 BINDING AND METHODS OF USING THE SAME | |
|
Jurisdiction
|
| |
Patent Number
|
| |
Expected
Expiration Date |
| |
Type
|
| |
Title
|
|
|
US
|
| | 9,045,541 | | | 2/6/2033 | | | Composition | | | CD47 ANTIBODIES AND METHODS OF USE THEREOF | |
|
US
|
| | 9,663,575 | | | 2/6/2033 | | | Method | | | CD47 ANTIBODIES AND METHODS OF USE THEREOF | |
|
Jurisdiction
|
| |
Patent Number
|
| |
Expected
Expiration Date |
| |
Type
|
| |
Title
|
|
|
Australia
|
| | 2013217114 | | | 2/6/2033 | | | Composition and method | | | CD47 ANTIBODIES AND METHODS OF USE THEREOF | |
|
Chile
|
| | 60943 | | | 2/6/2033 | | | | | | CD47 ANTIBODIES AND METHODS OF USE THEREOF | |
|
China
|
| |
ZL201380017900.0
|
| | 2/6/2033 | | | Composition and use | | | CD47 ANTIBODIES AND METHODS OF USE THEREOF | |
|
Colombia
|
| | 14171778 | | | 2/6/2033 | | | | | | CD47 ANTIBODIES AND METHODS OF USE THEREOF | |
|
Costa Rica
|
| | 4109 | | | 2/6/2033 | | | | | | CD47 ANTIBODIES AND METHODS OF USE THEREOF | |
|
Eurasia
(validated in Russia) |
| | 34778 | | | 2/6/2033 | | | | | | CD47 ANTIBODIES AND METHODS OF USE THEREOF | |
|
Europe
(validated in AL, AT, BA, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LI, LU, LV, MC, ME, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR) |
| | 2812443 | | | 2/6/2033 | | | Composition and use | | | CD47 ANTIBODIES AND METHODS OF USE THEREOF | |
|
Hong Kong
|
| | 1205195 | | | 2/6/2033 | | | | | | CD47 ANTIBODIES AND METHODS OF USE THEREOF | |
|
Indonesia
|
| | IDP00005873 | | | 2/6/2033 | | | | | | CD47 ANTIBODIES AND METHODS OF USE THEREOF | |
|
Israel
|
| | 233934 | | | 2/6/2033 | | | Composition and use | | | CD47 ANTIBODIES AND METHODS OF USE THEREOF | |
|
India
|
| | 395453 | | | 2/6/2033 | | | | | | CD47 ANTIBODIES AND METHODS OF USE THEREOF | |
|
Japan
|
| | 6273212 | | | 2/6/2033 | | | Composition and use | | | CD47 ANTIBODIES AND METHODS OF USE THEREOF | |
|
Korea
|
| | 10-2100388 | | | 2/6/2033 | | | Composition and use | | | CD47 ANTIBODIES AND METHODS OF USE THEREOF | |
|
Korea
|
| | 10-2338833 | | | 2/6/2033 | | | | | | CD47 ANTIBODIES AND METHODS OF USE THEREOF | |
|
Jurisdiction
|
| |
Patent Number
|
| |
Expected
Expiration Date |
| |
Type
|
| |
Title
|
|
|
Mexico
|
| | 360772 | | | 2/6/2033 | | | Composition and use | | | CD47 ANTIBODIES AND METHODS OF USE THEREOF | |
|
Malaysia
|
| | MY-169341-A | | | 2/6/2033 | | | | | | CD47 ANTIBODIES AND METHODS OF USE THEREOF | |
|
New Zealand
|
| | 628314 | | | 2/6/2033 | | | Composition and use | | | CD47 ANTIBODIES AND METHODS OF USE THEREOF | |
|
Philippines
|
| | 1/2014/501758 | | | 2/6/2033 | | | | | | CD47 ANTIBODIES AND METHODS OF USE THEREOF | |
|
Singapore
|
| | 11201404638S | | | 2/6/2033 | | | | | | CD47 ANTIBODIES AND METHODS OF USE THEREOF | |
|
Ukraine
|
| | 116772 | | | 2/6/2033 | | | | | | CD47 ANTIBODIES AND METHODS OF USE THEREOF | |
|
South Africa
|
| | 201405864 | | | 2/6/2033 | | | | | | CD47 ANTIBODIES AND METHODS OF USE THEREOF | |
|
Vietnam
|
| | 10028772 | | | 2/6/2033 | | | | | | CD47 ANTIBODIES AND METHODS OF USE THEREOF | |
|
Australia
|
| | 2013377886 | | | 8/6/2033 | | | Composition, method, and use | | | NON-PLATELET DEPLETING AND NON-RED BLOOD CELL DEPLETING CD47 ANTIBODIES AND METHODS OF USE THEREOF | |
|
Australia
|
| | 2019200942 | | | 8/6/2033 | | | Composition, method, and use | | | NON-PLATELET DEPLETING AND NON-RED BLOOD CELL DEPLETING CD47 ANTIBODIES AND METHODS OF USE THEREOF | |
|
Chile
|
| | CL63005B | | | 2/6/2033 | | | | | | NON-PLATELET DEPLETING AND NON-RED BLOOD CELL DEPLETING CD47 ANTIBODIES AND METHODS OF USE THEREOF | |
|
Jurisdiction
|
| |
Patent Number
|
| |
Expected
Expiration Date |
| |
Type
|
| |
Title
|
|
|
China
(also registered in Macao) |
| |
ZL201380075409.3
|
| | 8/6/2033 | | | Composition and use | | | NON-PLATELET DEPLETING AND NON-RED BLOOD CELL DEPLETING CD47 ANTIBODIES AND METHODS OF USE THEREOF | |
|
Eurasia
(validated in Russia) |
| | 036963 | | | 8/6/2033 | | | | | | NON-PLATELET DEPLETING AND NON-RED BLOOD CELL DEPLETING CD47 ANTIBODIES AND METHODS OF USE THEREOF | |
|
Europe
(validated in DE, ES, FR, GB, IT) |
| | 2953643 | | | 8/6/2033 | | | | | | NON-PLATELET DEPLETING AND NON-RED BLOOD CELL DEPLETING CD47 ANTIBODIES AND METHODS OF USE THEREOF | |
|
Hong Kong
|
| | 1218863 | | | 8/6/2033 | | | | | | NON-PLATELET DEPLETING AND NON-RED BLOOD CELL DEPLETING CD47 ANTIBODIES AND METHODS OF USE THEREOF | |
|
Indonesia
|
| | IDP000058855 | | | 8/6/2033 | | | | | | NON-PLATELET DEPLETING AND NON-RED BLOOD CELL DEPLETING CD47 ANTIBODIES AND METHODS OF USE THEREOF | |
|
Israel
|
| | 240390 | | | 8/6/2033 | | | | | | NON-PLATELET DEPLETING AND NON-RED BLOOD CELL DEPLETING CD47 ANTIBODIES AND METHODS OF USE THEREOF | |
|
Israel
|
| | 274566 | | | 8/6/2033 | | | | | | NON-PLATELET DEPLETING AND NON-RED BLOOD CELL DEPLETING CD47 ANTIBODIES AND METHODS OF USE THEREOF | |
|
Jurisdiction
|
| |
Patent Number
|
| |
Expected
Expiration Date |
| |
Type
|
| |
Title
|
|
|
Japan
|
| | 6726238 | | | 8/6/2033 | | | | | | NON-PLATELET DEPLETING AND NON-RED BLOOD CELL DEPLETING CD47 ANTIBODIES AND METHODS OF USE THEREOF | |
|
Korea
|
| | 10-2170196 | | | 8/6/2033 | | | | | | NON-PLATELET DEPLETING AND NON-RED BLOOD CELL DEPLETING CD47 ANTIBODIES AND METHODS OF USE THEREOF | |
|
Korea
|
| | 10-2276974 | | | 8/6/2033 | | | | | | NON-PLATELET DEPLETING AND NON-RED BLOOD CELL DEPLETING CD47 ANTIBODIES AND METHODS OF USE THEREOF | |
|
Macao
|
| | J/003573 | | | 8/6/2033 | | | | | | NON-PLATELET DEPLETING AND NON-RED BLOOD CELL DEPLETING CD47 ANTIBODIES AND METHODS OF USE THEREOF | |
|
Mexico
|
| | MX393557 | | | 8/6/2033 | | | | | | NON-PLATELET DEPLETING AND NON-RED BLOOD CELL DEPLETING CD47 ANTIBODIES AND METHODS OF USE THEREOF | |
|
New Zealand
|
| | 710695 | | | 8/6/2033 | | | | | | NON-PLATELET DEPLETING AND NON-RED BLOOD CELL DEPLETING CD47 ANTIBODIES AND METHODS OF USE THEREOF | |
|
Peru
|
| | 9897 | | | 8/6/2033 | | | | | | NON-PLATELET DEPLETING AND NON-RED BLOOD CELL DEPLETING CD47 ANTIBODIES AND METHODS OF USE THEREOF | |
|
Jurisdiction
|
| |
Patent Number
|
| |
Expected
Expiration Date |
| |
Type
|
| |
Title
|
|
|
Philippines
|
| | 12015501729 | | | 8/6/2033 | | | | | | NON-PLATELET DEPLETING AND NON-RED BLOOD CELL DEPLETING CD47 ANTIBODIES AND METHODS OF USE THEREOF | |
|
Singapore
|
| | 10201706383X | | | 8/6/2033 | | | | | | NON-PLATELET DEPLETING AND NON-RED BLOOD CELL DEPLETING CD47 ANTIBODIES AND METHODS OF USE THEREOF | |
|
South Africa
|
| | 2015/05745 | | | 8/6/2033 | | | | | | NON-PLATELET DEPLETING AND NON-RED BLOOD CELL DEPLETING CD47 ANTIBODIES AND METHODS OF USE THEREOF | |
|
South Africa
|
| | 201905292 | | | 8/6/2033 | | | | | | NON-PLATELET DEPLETING AND NON-RED BLOOD CELL DEPLETING CD47 ANTIBODIES AND METHODS OF USE THEREOF | |
|
Vietnam
|
| | 10029478 | | | 8/6/2033 | | | | | | NON-PLATELET DEPLETING AND NON-RED BLOOD CELL DEPLETING CD47 ANTIBODIES AND METHODS OF USE THEREOF | |
| | |
As of March 31, 2024
|
| |||||||||
| | |
Historical
Inhibrx, Inc. |
| |
Pro Forma
SpinCo |
| ||||||
| | |
(In thousands, except
for share amounts) |
| |||||||||
Cash and cash equivalents
|
| | | $ | 252,483 | | | | | $ | 252,483 | | |
Debt, including current and long-term: | | | | | | | | | | | | | |
Current portion of long-term debt, net of discount
|
| | | | 3,632 | | | | | | — | | |
Long-term debt, including final payment fee
|
| | | | 204,578 | | | | | | — | | |
Total debt
|
| | | | 208,210 | | | | | | — | | |
Stockholders’ equity: | | | | | | | | | | | | | |
Preferred stock, $0.0001 par value, 15,000,000 shares authorized and no shares
outstanding as of March 31, 2024 (historical Inhibrx, Inc.); 15,000,000 shares authorized and no shares outstanding as of March 31, 2024 (pro forma SpinCo) |
| | | | — | | | | | | — | | |
Common stock, $0.0001 par value, 120,000,000 shares authorized and
49,234,225 shares issued and outstanding as of March 31, 2024 (historical Inhibrx, Inc.); 120,000,000 shares authorized and 13,380,864 shares issued and outstanding as of March 31, 2024 (pro forma SpinCo) |
| | | | 5 | | | | | | 1 | | |
Additional paid-in-capital
|
| | | | 704,007 | | | | | | 241,712 | | |
Accumulated deficit earnings
|
| | | | (692,444) | | | | | | — | | |
Total stockholders’ equity
|
| | | | 11,568 | | | | | | 241,713 | | |
Total capitalization
|
| | | $ | 219,778 | | | | | $ | 241,713 | | |
| | |
Historical
Inhibrx, Inc. (Note 1) |
| |
Separation
of the RemainCo Business (Note 2) |
| |
Transaction
Accounting Adjustments (Note 3) |
| | | | | | | |
Autonomous
Entity Adjustments (Note 4) |
| | | | | | | |
Pro Forma
|
| |||||||||||||||
| | |
(In thousands, except per share amounts)
|
| |||||||||||||||||||||||||||||||||||||||
Revenue: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
License fee revenue
|
| | | $ | — | | | | | $ | — | | | | | $ | — | | | | | | | | | | | $ | — | | | | | | | | | | | $ | — | | |
Grant revenue
|
| | | | — | | | | | | — | | | | | | — | | | | | | | | | | | | — | | | | | | | | | | | | — | | |
Total revenue
|
| | | | — | | | | | | — | | | | | | — | | | | | | | | | | | | — | | | | | | | | | | | | — | | |
Operating expenses: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Research and development
|
| | | | 63,851 | | | | | | (19,953) | | | | | | — | | | | | | | | | | | | — | | | | | | | | | | | | 43,898 | | |
General and administrative
|
| | | | 9,974 | | | | | | (368) | | | | | | — | | | | | | | | | | | | — | | | | | | | | | | | | 9,606 | | |
Total operating expenses
|
| | | | 73,825 | | | | | | (20,231) | | | | | | — | | | | | | | | | | | | — | | | | | | | | | | | | 53,504 | | |
Loss from operations
|
| | | | (73,825) | | | | | | 20,321 | | | | | | — | | | | | | | | | | | | | | | | | | | | | | | | (53,504) | | |
Other income (expense): | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Interest expense
|
| | | | (8,130) | | | | | | — | | | | | | 8,130 | | | | | | (E) | | | | | | — | | | | | | | | | | | | — | | |
Interest income
|
| | | | 3,304 | | | | | | — | | | | | | — | | | | | | | | | | | | — | | | | | | | | | | | | 3,304 | | |
Other expense, net
|
| | | | (59) | | | | | | — | | | | | | — | | | | | | | | | | | | — | | | | | | | | | | | | (59) | | |
Total other expense
|
| | | | (4,885) | | | | | | — | | | | | | 8,130 | | | | | | | | | | | | — | | | | | | | | | | | | 3,245 | | |
Income (loss) before provision for income taxes
|
| | | | (78,710) | | | | | | 20,321 | | | | | | 8,130 | | | | | | | | | | | | — | | | | | | | | | | | | (50,259) | | |
Provision for income taxes
|
| | | | — | | | | | | — | | | | | | 1,814 | | | | | | (F) | | | | | | — | | | | | | | | | | | | 1,814 | | |
Loss on equity method investment
|
| | | | — | | | | | | — | | | | | | — | | | | | | | | | | | | — | | | | | | | | | | | | — | | |
Net income (loss)
|
| | | $ | (78,710) | | | | | $ | 20,321 | | | | | $ | 6,316 | | | | | | | | | | | $ | — | | | | | | | | | | | $ | (52,073) | | |
Net income (loss) per share, basic and
diluted |
| | | $ | (1.44) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | (H) | | | | | $ | (3.46) | | |
Weighted-average shares of common stock outstanding, basic and diluted
|
| | | | 54,544 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | (H) | | | | | | 15,060 | | |
| | |
Historical
Inhibrx, Inc. (Note 1) |
| |
Separation
of the RemainCo Business (Note 2) |
| |
Transaction
Accounting Adjustments (Note 3) |
| | | | |
Autonomous
Entity Adjustments (Note 4) |
| | | | |
Pro Forma
|
| | | | | | | |||||||||||||||
| | |
(In thousands, except per share amounts)
|
| | | |||||||||||||||||||||||||||||||||||||
Revenue: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | ||||
License fee revenue
|
| | | $ | 1,800 | | | | | $ | (166) | | | | | $ | — | | | | | | | | $ | — | | | | | | | | $ | 1,634 | | | | | ||||
Grant revenue
|
| | | | — | | | | | | — | | | | | | — | | | | | | | | | — | | | | | | | | | — | | | | | ||||
Total revenue
|
| | | | 1,800 | | | | | | (166) | | | | | | — | | | | | | | | | — | | | | | | | | | 1,634 | | | | | ||||
Operating expenses: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | ||||
Research and development
|
| | | | 191,640 | | | | | | (54,320) | | | | | | 28,690 | | | |
(B)
|
| | | | 6,916 | | | |
(I)
|
| | | | 172,926 | | | | | ||||
General and administrative
|
| | | | 29,381 | | | | | | (1,377) | | | | | | 83,353 | | | |
(A), (B)
|
| | | | — | | | | | | | | | 111,357 | | | | | ||||
Total operating expenses
|
| | | | 221,021 | | | | | | (55,697) | | | | | | 112,043 | | | | | | | | | 6,916 | | | | | | | | | 284,283 | | | | | ||||
Loss from operations
|
| | | | (219,221) | | | | | | 55,531 | | | | | | (112,043) | | | | | | | | | (6,916) | | | | | | | | | (282,649) | | | | | ||||
Other income (expense): | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | ||||
Interest expense
|
| | | | (31,840) | | | | | | — | | | | | | 31,840 | | | |
(E)
|
| | | | — | | | | | | | | | — | | | | | ||||
Interest income
|
| | | | 11,917 | | | | | | — | | | | | | — | | | | | | | | | — | | | | | | | | | 11,917 | | | | | ||||
Other expense, net
|
| | | | (580) | | | | | | (9,790) | | | | | | 1,692,954 | | | |
(C)
|
| | | | 7,436 | | | |
(I)
|
| | | | 1,690,020 | | | | | ||||
Total other expense
|
| | | | (20,503) | | | | | | (9,790) | | | | | | 1,724,794 | | | | | | | | | 7,436 | | | | | | | | | 1,701,937 | | | | | ||||
Income (loss) before provision for income taxes
|
| | | | (239,724) | | | | | | 45,741 | | | | | | 1,612,751 | | | | | | | | | 520 | | | | | | | | | 1,419,288 | | | | | ||||
Provision for income taxes
|
| | | | 3 | | | | | | — | | | | | | (17,893) | | | |
(F)
|
| | | | 116 | | | |
(J)
|
| | | | (17,774) | | | | | ||||
Loss on equity method investment
|
| | | | 1,634 | | | | | | — | | | | | | — | | | | | | | | | — | | | | | | | | | 1,634 | | | | | ||||
Net income (loss)
|
| | | $ | (241,361) | | | | | $ | 45,741 | | | | | $ | 1,630,644 | | | | | | | | $ | 404 | | | | | | | | $ | 1,435,428 | | | | | ||||
Net income (loss) per share, basic
and diluted |
| | | $ | (5.12) | | | | | | | | | | | | | | | | | | | | | | | | |
(H)
|
| | | $ | 98.64 | | | | | ||||
Weighted-average shares of common stock outstanding, basic and diluted
|
| | | | 47,130 | | | | | | | | | | | | | | | | | | | | | | | | |
(H)
|
| | | | 14,553 | | | | |
| | |
Historical
Inhibrx, Inc. (Note 1) |
| |
Separation
of the RemainCo Business (Note 2) |
| |
Transaction
Accounting Adjustments (Note 3) |
| | | | |
Autonomous
Entity Adjustments (Note 4) |
| |
Pro Forma
|
| |||||||||||||||
| | |
(In thousands, except share and per share amounts)
|
| ||||||||||||||||||||||||||||||
Assets | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Current assets: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Cash and cash equivalents
|
| | | $ | 252,483 | | | | | $ | — | | | | | $ | — | | | |
(C), (D)
|
| | | $ | — | | | | | $ | 252,483 | | |
Accounts receivable
|
| | | | 171 | | | | | | — | | | | | | — | | | | | | | | | — | | | | | | 171 | | |
Other receivables
|
| | | | 2,867 | | | | | | (2,734) | | | | | | — | | | | | | | | | — | | | | | | 133 | | |
Prepaid expenses and other current assets
|
| | | | 19,017 | | | | | | (5,138) | | | | | | — | | | | | | | | | — | | | | | | 13,879 | | |
Total current assets
|
| | | | 274,538 | | | | | | (7,872) | | | | | | — | | | | | | | | | — | | | | | | 266,666 | | |
Property and equipment, net
|
| | | | 6,966 | | | | | | — | | | | | | — | | | | | | | | | — | | | | | | 6,966 | | |
Operating right-of-use asset
|
| | | | 2,487 | | | | | | — | | | | | | — | | | | | | | | | — | | | | | | 2,487 | | |
Other non-current assets
|
| | | | 4,586 | | | | | | — | | | | | | — | | | | | | | | | — | | | | | | 4,586 | | |
Total assets
|
| | | $ | 288,577 | | | | | $ | (7,872) | | | | | $ | — | | | | | | | | $ | — | | | | | $ | 280,705 | | |
Liabilities and stockholders’ equity | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Current liabilities: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Accounts payable
|
| | | $ | 14,792 | | | | | $ | (2,425) | | | | | $ | — | | | | | | | | $ | — | | | | | $ | 12,367 | | |
Accrued expenses
|
| | | | 51,329 | | | | | | (94,216) | | | | | | 66,834 | | | |
(A)
|
| | | | — | | | | | | 23,947 | | |
Current portion of long-term debt, net of discount
|
| | | | 3,632 | | | | | | (3,632) | | | | | | — | | | | | | | | | — | | | | | | — | | |
Current portion of lease liability
|
| | | | 2,117 | | | | | | — | | | | | | — | | | | | | | | | — | | | | | | 2,117 | | |
Total current liabilities
|
| | | | 71,870 | | | | | | (100,273) | | | | | | 66,834 | | | | | | | | | — | | | | | | 38,431 | | |
Long-term debt
|
| | | | 204,578 | | | | | | (204,578) | | | | | | — | | | | | | | | | — | | | | | | — | | |
Non-current portion of lease liability
|
| | | | 561 | | | | | | — | | | | | | — | | | | | | | | | — | | | | | | 561 | | |
Total liabilities
|
| | | | 277,009 | | | | | | (304,851) | | | | | | 66,834 | | | | | | | | | — | | | | | | 38,992 | | |
Commitments and contingencies | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Stockholders’ equity | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Preferred stock, $0.0001 par value, 15,000,000 shares authorized and no shares outstanding as of March 31, 2024
|
| | | | — | | | | | | — | | | | | | — | | | | | | | | | — | | | | | | — | | |
Common stock, $0.0001 par value, 120,000,000 shares authorized as of March 31, 2024; 49,234,225 shares issued and outstanding as of March 31, 2024
|
| | | | 5 | | | | | | — | | | | | | (5) | | | |
(G)
|
| | | | — | | | | | | — | | |
Common stock, $0.0001 par value; 120,000,000 shares authorized and 13,380,864 shares issued and outstanding on a pro forma basis
|
| | | | — | | | | | | — | | | | | | 1 | | | |
(G)
|
| | | | — | | | | | | 1 | | |
Additional paid-in-capital
|
| | | | 704,007 | | | | | | — | | | | | | (462,295) | | | |
(B), (C),
(D), (G) |
| | | | — | | | | | | 241,712 | | |
Accumulated deficit
|
| | | | (692,444) | | | | | | 296,979 | | | | | | 395,465 | | | |
(A), (B),
(C), (D) |
| | | | — | | | | | | — | | |
Total stockholders’ equity
|
| | | | 11,568 | | | | | | 296,979 | | | | | | (66,834) | | | | | | | | | — | | | | | | 241,713 | | |
Total liabilities and stockholders’ equity
|
| | | $ | 288,577 | | | | | $ | (7,872) | | | | | $ | — | | | | | | | | $ | — | | | | | $ | 280,705 | | |
| | |
THREE MONTHS
ENDED MARCH 31, |
| |
CHANGE
|
| | | | ||||||||||||||||||
| | |
2024
|
| |
2023
|
| |
($)
|
| |
(%)
|
| | ||||||||||||||
Revenue: | | | | | | | | | | | | | | | | | | | | | | | | | | | ||
License fee revenue
|
| | | $ | — | | | | | $ | 17 | | | | | $ | (17) | | | | | | (100)% | | | | ||
Total revenue
|
| | | | — | | | | | | 17 | | | | | | (17) | | | | | | (100)% | | | | ||
Operating expense: | | | | | | | | | | | | | | | | | | | | | | | | | | | ||
Research and development
|
| | | | 63,851 | | | | | | 37,386 | | | | | | 26,465 | | | | | | 71% | | | | ||
General and administrative
|
| | | | 9,974 | | | | | | 6,397 | | | | | | 3,577 | | | | | | 56% | | | | ||
Total operating expense
|
| | | | 73,825 | | | | | | 43,783 | | | | | | 30,042 | | | | | | 69% | | | | ||
Loss from operations
|
| | | | (73,825) | | | | | | (43,766) | | | | | | (30,059) | | | | | | 69% | | | | ||
Other income (expense) | | | | | | | | | | | | | | | | | | | | | | | | | | | ||
Interest expense
|
| | | | (8,130) | | | | | | (7,563) | | | | | | (567) | | | | | | 7% | | | | ||
Interest income
|
| | | | 3,304 | | | | | | 2,483 | | | | | | 821 | | | | | | 33% | | | | ||
Other expense, net
|
| | | | (59) | | | | | | (70) | | | | | | 11 | | | | | | (16)% | | | | ||
Total other expense
|
| | | | (4,885) | | | | | | (5,150) | | | | | | 265 | | | | | | (5)% | | | | ||
Net loss
|
| | | $ | (78,710) | | | | | $ | (48,916) | | | | | $ | (29,794) | | | | | | 61% | | | |
| | |
THREE MONTHS
ENDED MARCH 31, |
| |
CHANGE
|
| ||||||||||||||||||
| | |
2024
|
| |
2023
|
| |
($)
|
| |
(%)
|
| ||||||||||||
External expenses: | | | | | | | | | | | | | | | | | | | | | | | | | |
Contract manufacturing
|
| | | $ | 25,202 | | | | | $ | 10,328 | | | | | $ | 14,874 | | | | | | 144% | | |
Clinical trials
|
| | | | 19,778 | | | | | | 10,019 | | | | | | 9,759 | | | | | | 97% | | |
Other external research and development
|
| | | | 2,034 | | | | | | 2,286 | | | | | | (252) | | | | | | (11)% | | |
Internal expenses: | | | | | | | | | | | | | | | | | | | | | | | | | |
Personnel
|
| | | | 13,238 | | | | | | 11,302 | | | | | | 1,936 | | | | | | 17% | | |
Equipment, depreciation, and facility
|
| | | | 1,920 | | | | | | 1,798 | | | | | | 122 | | | | | | 7% | | |
Other internal research and development
|
| | | | 1,679 | | | | | | 1,653 | | | | | | 26 | | | | | | 2% | | |
Total research and development expenses
|
| | | $ | 63,851 | | | | | $ | 37,386 | | | | | $ | 26,465 | | | | | | 71% | | |
| | |
YEAR ENDED
DECEMBER 31, |
| |
CHANGE
|
| ||||||||||||||||||
| | |
2023
|
| |
2022
|
| |
($)
|
| |
(%)
|
| ||||||||||||
Revenue: | | | | | | | | | | | | | | | | | | | | | | | | | |
License fee revenue
|
| | | $ | 1,800 | | | | | $ | 2,178 | | | | | $ | (378) | | | | | | (17)% | | |
Grant revenue
|
| | | | — | | | | | | 14 | | | | | | (14) | | | | | | (100)% | | |
Total revenue
|
| | | | 1,800 | | | | | | 2,192 | | | | | | (392) | | | | | | (18)% | | |
Operating expenses: | | | | | | | | | | | | | | | | | | | | | | | | | |
Research and development
|
| | | | 191,640 | | | | | | 110,186 | | | | | | 81,454 | | | | | | 74% | | |
General and administrative
|
| | | | 29,381 | | | | | | 21,123 | | | | | | 8,258 | | | | | | 39% | | |
Total operating expenses
|
| | | | 221,021 | | | | | | 131,309 | | | | | | 89,712 | | | | | | 68% | | |
Loss from operations
|
| | | | (219,221) | | | | | | (129,117) | | | | | | (90,104) | | | | | | 70% | | |
Other income (expense): | | | | | | | | | | | | | | | | | | | | | | | | | |
Interest expense
|
| | | | (31,840) | | | | | | (18,181) | | | | | | (13,659) | | | | | | 75% | | |
Interest income
|
| | | | 11,917 | | | | | | 2,074 | | | | | | 9,843 | | | | | | 475% | | |
Other income (expense), net
|
| | | | (580) | | | | | | 1 | | | | | | (581) | | | | | | (58,100)% | | |
Total other expense
|
| | | | (20,503) | | | | | | (16,106) | | | | | | (4,397) | | | | | | 27% | | |
Provision for income taxes
|
| | | | 3 | | | | | | 3 | | | | | | — | | | | | | —% | | |
Loss on equity method investment
|
| | | | 1,634 | | | | | | — | | | | | | 1,634 | | | | | | 100% | | |
Net loss
|
| | | $ | (241,361) | | | | | $ | (145,226) | | | | | $ | (96,135) | | | | | | 66% | | |
| | |
YEAR ENDED DECEMBER 31,
|
| |
CHANGE
|
| ||||||||||||||||||
| | |
2023
|
| |
2022
|
| |
($)
|
| |
(%)
|
| ||||||||||||
External expenses: | | | | | | | | | | | | | | | | | | | | | | | | | |
Contract manufacturing
|
| | | $ | 77,248 | | | | | $ | 27,367 | | | | | $ | 49,881 | | | | | | 182% | | |
Clinical trials
|
| | | | 42,960 | | | | | | 28,988 | | | | | | 13,972 | | | | | | 48% | | |
Other external research and development
|
| | | | 10,480 | | | | | | 6,760 | | | | | | 3,720 | | | | | | 55% | | |
Internal expenses: | | | | | | | | | | | | | | | | | | | | | | | | | |
Personnel
|
| | | | 47,818 | | | | | | 35,937 | | | | | | 11,881 | | | | | | 33% | | |
Equipment, depreciation, and facility
|
| | | | 7,361 | | | | | | 6,151 | | | | | | 1,210 | | | | | | 20% | | |
Other internal research and development
|
| | | | 5,773 | | | | | | 4,983 | | | | | | 790 | | | | | | 16% | | |
Total research and development expenses
|
| | | $ | 191,640 | | | | | $ | 110,186 | | | | | $ | 81,454 | | | | | | 74% | | |
| | |
THREE MONTHS ENDED
MARCH 31, |
| |||||||||
| | |
2024
|
| |
2023
|
| ||||||
Net cash used in operating activities
|
| | | $ | (63,050) | | | | | $ | (39,944) | | |
Net cash used in investing activities
|
| | | | (1,119) | | | | | | (23) | | |
Net cash provided by financing activities
|
| | | | 38,728 | | | | | | 356 | | |
Net decrease in cash and cash equivalents
|
| | | $ | (25,441) | | | | | $ | (39,611) | | |
| | |
YEAR ENDED
DECEMBER 31, |
| |||||||||
| | |
2023
|
| |
2022
|
| ||||||
Net cash used in operating activities
|
| | | $ | (193,309) | | | | | $ | (115,301) | | |
Net cash used in investing activities
|
| | | | (4,593) | | | | | | (686) | | |
Net cash provided by financing activities
|
| | | | 201,961 | | | | | | 258,551 | | |
Net increase in cash
|
| | | $ | 4,059 | | | | | $ | 142,564 | | |
| | |
THREE MONTHS
ENDED MARCH 31, |
| |
CHANGE
|
| ||||||||||||||||||
| | |
2024
|
| |
2023
|
| |
($)
|
| |
(%)
|
| ||||||||||||
Operating expense: | | | | | | | | | | | | | | | | | | | | | | | | | |
Research and development
|
| | | | 40,432 | | | | | | 34,207 | | | | | | 6,225 | | | | | | 18% | | |
General and administrative
|
| | | | 8,782 | | | | | | 5,334 | | | | | | 3,448 | | | | | | 65% | | |
Total operating expense
|
| | | | 49,214 | | | | | | 39,541 | | | | | | 9,673 | | | | | | 24% | | |
Loss from operations
|
| | | | (49,214) | | | | | | (39,541) | | | | | | (9,673) | | | | | | 24% | | |
Other income (expense) | | | | | | | | | | | | | | | | | | | | | | | | | |
Other expense, net
|
| | | | (59) | | | | | | (70) | | | | | | 11 | | | | | | (16)% | | |
Total other expense
|
| | | | (59) | | | | | | (70) | | | | | | 11 | | | | | | (16)% | | |
Net loss
|
| | | $ | (49,273) | | | | | $ | (39,611) | | | | | $ | (9,662) | | | | | | 24% | | |
| | |
THREE MONTHS
ENDED MARCH 31, |
| |
CHANGE
|
| ||||||||||||||||||
| | |
2024
|
| |
2023
|
| |
($)
|
| |
(%)
|
| ||||||||||||
External expenses: | | |
|
| |
|
| |
|
| |
|
| ||||||||||||
Clinical trials
|
| | | $ | 13,774 | | | | | $ | 8,897 | | | | | $ | 4,877 | | | | | | 55% | | |
Contract manufacturing
|
| | | | 11,434 | | | | | | 10,295 | | | | | | 1,139 | | | | | | 11% | | |
Other external research and development
|
| | | | 1,851 | | | | | | 2,160 | | | | | | (309) | | | | | | (14)% | | |
| | |
THREE MONTHS
ENDED MARCH 31, |
| |
CHANGE
|
| ||||||||||||||||||
| | |
2024
|
| |
2023
|
| |
($)
|
| |
(%)
|
| ||||||||||||
Internal expenses: | | | | | | | | | | | | | | | | | | | | | | | | | |
Personnel
|
| | | | 10,134 | | | | | | 9,770 | | | | | | 364 | | | | | | 4% | | |
Equipment, depreciation, and facility
|
| | | | 1,671 | | | | | | 1,667 | | | | | | 4 | | | | | | —% | | |
Other internal research and development
|
| | | | 1,568 | | | | | | 1,418 | | | | | | 150 | | | | | | 11% | | |
Total research and development expenses
|
| | | $ | 40,432 | | | | | $ | 34,207 | | | | | $ | 6,225 | | | | | | 18% | | |
|
| | |
YEAR ENDED DECEMBER 31,
|
| |
CHANGE
|
| ||||||||||||||||||
| | |
2023
|
| |
2022
|
| |
($)
|
| |
(%)
|
| ||||||||||||
Revenue: | | | | | | | | | | | | | | | | | | | | | | | | | |
License fee revenue
|
| | | $ | 1,634 | | | | | $ | 1,301 | | | | | $ | 333 | | | | | | 26% | | |
Grant revenue
|
| | | | — | | | | | | 14 | | | | | | (14) | | | | | | (100)% | | |
Total revenue
|
| | | | 1,634 | | | | | | 1,315 | | | | | | 319 | | | | | | 24% | | |
Operating expenses: | | | | | | | | | | | | | | | | | | | | | | | | | |
Research and development
|
| | | | 130,133 | | | | | | 101,603 | | | | | | 28,530 | | | | | | 28% | | |
General and administrative
|
| | | | 24,248 | | | | | | 15,035 | | | | | | 9,213 | | | | | | 61% | | |
Total operating expenses
|
| | | | 154,381 | | | | | | 116,638 | | | | | | 37,743 | | | | | | 32% | | |
Loss from operations
|
| | | | (152,747) | | | | | | (115,323) | | | | | | (37,424) | | | | | | 32% | | |
Other income (expense): | | | | | | | | | | | | | | | | | | | | | | | | | |
Other income (expense), net
|
| | | | (580) | | | | | | 1 | | | | | | (581) | | | | | | (58,100)% | | |
Total other income (expense)
|
| | | | (580) | | | | | | 1 | | | | | | (581) | | | | | | (58,100)% | | |
Provision for income taxes
|
| | | | 3 | | | | | | 3 | | | | | | — | | | | | | —% | | |
Loss on equity method investment
|
| | | | 1,634 | | | | | | — | | | | | | 1,634 | | | | | | 100% | | |
Net loss
|
| | | $ | (154,964) | | | | | $ | (115,325) | | | | | $ | (39,639) | | | | | | 34% | | |
| | |
YEAR ENDED
DECEMBER 31, |
| |
CHANGE
|
| ||||||||||||||||||
| | |
2023
|
| |
2022
|
| |
($)
|
| |
(%)
|
| ||||||||||||
External expenses: | | | | | | | | | | | | | | | | | | | | | | | | | |
Clinical trials
|
| | | $ | 35,270 | | | | | $ | 25,927 | | | | | $ | 9,343 | | | | | | 36% | | |
Contract manufacturing
|
| | | | 32,020 | | | | | | 25,500 | | | | | | 6,520 | | | | | | 26% | | |
Other external research and development
|
| | | | 9,155 | | | | | | 6,360 | | | | | | 2,795 | | | | | | 44% | | |
Internal expenses: | | | | | | | | | | | | | | | | | | | | | | | | | |
Personnel
|
| | | | 41,275 | | | | | | 33,523 | | | | | | 7,752 | | | | | | 23% | | |
Equipment, depreciation, and facility
|
| | | | 6,853 | | | | | | 5,818 | | | | | | 1,035 | | | | | | 18% | | |
Other internal research and development
|
| | | | 5,560 | | | | | | 4,475 | | | | | | 1,085 | | | | | | 24% | | |
Total research and development expenses
|
| | | $ | 130,133 | | | | | $ | 101,603 | | | | | $ | 28,530 | | | | | | 28% | | |
| | |
THREE MONTHS
ENDED MARCH 31, |
| |||||||||
| | |
2024
|
| |
2023
|
| ||||||
Net cash used in operating activities
|
| | | $ | (40,314) | | | | | $ | (26,939) | | |
Net cash used in investing activities
|
| | | | (1,119) | | | | | | (23) | | |
Net cash provided by financing activities
|
| | | | 41,433 | | | | | | 26,962 | | |
Net increase in cash and cash equivalents
|
| | | $ | — | | | | | $ | — | | |
| | |
YEAR ENDED DECEMBER 31,
|
| |||||||||
| | |
2023
|
| |
2022
|
| ||||||
Net cash used in operating activities
|
| | | $ | (129,007) | | | | | $ | (90,811) | | |
Net cash used in investing activities
|
| | | | (4,593) | | | | | | (686) | | |
Net cash provided by financing activities
|
| | | | 133,600 | | | | | | 91,497 | | |
Net increase in cash
|
| | | $ | — | | | | | $ | — | | |
Name
|
| |
Age
|
| |
Position
|
|
Mark P. Lappe | | | 57 | | | Chief Executive Officer, President and Chairman of the board of directors | |
Kelly D. Deck, C.P.A | | | 44 | | | Chief Financial Officer | |
Brendan P. Eckelman, Ph.D. | | | 45 | | | Chief Scientific Officer | |
Douglas G. Forsyth | | | 55 | | | Director | |
Jon Faiz Kayyem, Ph.D. | | | 60 | | | Director | |
Kimberly Manhard | | | 64 | | | Director | |
Kristiina Vuori, M.D., Ph.D.
|
| | 56 | | | Director | |
|
Class I
|
| |
Class II
|
| |
Class III
|
|
|
First Annual Meeting
|
| |
Second Annual Meeting
|
| |
Third Annual Meeting
|
|
|
Jon Faiz Kayyem, Ph.D.
|
| |
Douglas G. Forsyth
|
| |
Mark P. Lappe
|
|
|
Kristiina Vuori, M.D., Ph.D.
|
| |
Kimberly Manhard
|
| | | |
Name
|
| |
Fees Earned
or Paid in Cash ($) |
| |
Stock
Awards ($) |
| |
Option
Awards ($)(1) |
| |
All Other
Compensation ($)(2) |
| |
Total ($)
|
| |||||||||||||||
Douglas G. Forsyth
|
| | | $ | 63,000 | | | | | $ | — | | | | | $ | 254,030 | | | | | $ | — | | | | | $ | 317,030 | | |
Jon Faiz Kayyem, Ph.D.
|
| | | $ | 52,500 | | | | | $ | — | | | | | $ | 254,030 | | | | | $ | — | | | | | $ | 306,530 | | |
Kimberly Manhard
|
| | | $ | 44,000 | | | | | $ | — | | | | | $ | 254,030 | | | | | $ | — | | | | | $ | 298,030 | | |
Kristiina Vuori, M.D., Ph.D.
|
| | | $ | 46,500 | | | | | $ | — | | | | | $ | 254,030 | | | | | $ | — | | | | | $ | 300,530 | | |
Name
|
| |
Stock Awards
Outstanding at December 31, 2023 (#) |
| |
Option
Awards Outstanding at December 31, 2023 (#) |
| ||||||
Douglas G. Forsyth.
|
| | | | — | | | | | | 62,259 | | |
Jon Faiz Kayyem, Ph.D.
|
| | | | — | | | | | | 62,259 | | |
Kimberly Manhard
|
| | | | — | | | | | | 65,759 | | |
Kristiina Vuori, M.D., Ph.D.
|
| | | | — | | | | | | 60,000 | | |
Position
|
| |
Retainer
|
| |||
Board Member
|
| | | $ | 35,000 | | |
Board Chairperson
|
| | | $ | 35,000 | | |
Audit Committee Chair
|
| | | $ | 15,000 | | |
Compensation Committee Chair
|
| | | $ | 10,000 | | |
Nominating Committee Chair
|
| | | $ | 8,000 | | |
Audit Committee Member
|
| | | $ | 7,500 | | |
Compensation Committee Member
|
| | | $ | 5,000 | | |
Nominating Committee Member
|
| | | $ | 4,000 | | |
Name and Principal Position
|
| |
Year
|
| |
Salary ($)
|
| |
Bonus ($)
|
| |
Option
Awards ($)(1) |
| |
Non-Equity
Incentive Plan Compensation ($)(2) |
| |
All Other
Compensation ($)(3) |
| |
Total ($)
|
| |||||||||||||||||||||
Mark P. Lappe
Chief Executive Officer and President |
| | | | 2023 | | | | | | 675,000 | | | | | | — | | | | | | 1,706,771 | | | | | | 405,000 | | | | | | 15,250 | | | | | | 2,802,021 | | |
| | | 2022 | | | | | | 650,000 | | | | | | — | | | | | | — | | | | | | 357,500 | | | | | | 15,250 | | | | | | 1,022,750 | | | ||
Brendan P. Eckelman, Ph.D.
Chief Scientific Officer |
| | | | 2023 | | | | | | 520,000 | | | | | | | | | | | | 682,708 | | | | | | 234,000 | | | | | | 15,250 | | | | | | 1,451,958 | | |
| | | 2022 | | | | | | 475,000 | | | | | | — | | | | | | — | | | | | | 213,750 | | | | | | 15,250 | | | | | | 704,000 | | | ||
Kelly D. Deck, C.P.A.
Chief Financial Officer |
| | | | 2023 | | | | | | 430,000 | | | | | | | | | | | | 512,031 | | | | | | 193,500 | | | | | | 13,368 | | | | | | 1,148,899 | | |
| | | 2022 | | | | | | 380,000 | | | | | | — | | | | | | 491,327 | | | | | | 133,000 | | | | | | 18,168 | | | | | | 1,022,495 | | |
Name
|
| |
Cash
Severance |
| |
Health and
Other Insurance Benefits |
| |
Stock
Options (Unvested and Accelerated) |
| |
Total
|
| ||||||||||||
Mark P. Lappe | | | | | | | | | | | | | | | | | | | | | | | | | |
Termination for reasons other than Cause, death or Disability, or for Good Reason
|
| | | $ | 675,000 | | | | | $ | 28,271 | | | | | $ | 1,739,781 | | | | | $ | 2,443,052 | | |
Termination in connection with a Change of Control
|
| | | $ | 1,620,000 | | | | | $ | 42,406 | | | | | $ | 2,705,552 | | | | | $ | 4,367,958 | | |
Brendan P. Eckelman, Ph.D. | | | | | | | | | | | | | | | | | | | | | | | | | |
Termination for reasons other than Cause, death or Disability, or for Good Reason
|
| | | $ | 520,000 | | | | | $ | 28,425 | | | | | $ | 581,467 | | | | | $ | 1,129,893 | | |
Termination in connection with a Change of Control
|
| | | $ | 1,131,000 | | | | | $ | 42,638 | | | | | $ | 958,225 | | | | | $ | 2,131,863 | | |
Kelly D. Deck, C.P.A. | | | | | | | | | | | | | | | | | | | | | | | | | |
Termination for reasons other than Cause, death or Disability, or for Good Reason
|
| | | $ | 430,000 | | | | | $ | 28,271 | | | | | $ | 836,837 | | | | | $ | 1,295,108 | | |
Termination in connection with a Change of Control
|
| | | $ | 935,250 | | | | | $ | 42,406 | | | | | $ | 1,273,677 | | | | | $ | 2,251,333 | | |
Name
|
| |
Title
|
| |
Fiscal
Year 2023 Incentive Bonus Rate at Target |
| |
2023
Evaluation of Company Performance |
| |
Final Ratio
Incentive Bonus as a Percentage of Base Salary |
| |
Fiscal Year
2023 Incentive Bonus Award ($) |
| ||||||||||||
Mark P. Lappe
|
| |
Chief Executive Officer
and President |
| | | | 60% | | | | | | 100% | | | | | | 60% | | | | | $ | 405,000 | | |
Brendan P. Eckelman, Ph.D.
|
| |
Chief Scientific Officer
|
| | | | 45% | | | | | | 100% | | | | | | 45% | | | | | $ | 234,000 | | |
Kelly D. Deck, C.P.A.
|
| |
Chief Financial Officer
|
| | | | 45% | | | | | | 100% | | | | | | 45% | | | | | $ | 193,500 | | |
| | |
Option Awards
|
| |||||||||||||||||||||||||||
Name
|
| |
Number of
Securities Underlying Unexercised Options (#) Exercisable |
| |
Number of
Securities Underlying Unexercised Options (#) Unexercisable |
| |
Equity
Incentive Plan Awards: Number of Securities Underlying Unexercised Unearned Options (#) |
| |
Option
Exercise Price ($) |
| |
Option
Expiration Date |
| |||||||||||||||
Mark P. Lappe
|
| | | | 105,729 | | | | | | 39,271 | | | | | | — | | | | | $ | 33.63 | | | | | | 1/15/2031(1) | | |
| | | | | — | | | | | | 100,000 | | | | | | — | | | | | $ | 23.30 | | | | | | 1/3/2033(2) | | |
Brendan P. Eckelman, Ph.D.
|
| | | | 29,167 | | | | | | 10,833 | | | | | | — | | | | | $ | 33.63 | | | | | | 1/15/2031(1) | | |
| | | | | — | | | | | | 40,000 | | | | | | — | | | | | $ | 23.30 | | | | | | 1/3/2033(2) | | |
Kelly D. Deck, C.P.A.
|
| | | | 80,543 | | | | | | — | | | | | | — | | | | | $ | 10.52 | | | | | | 11/26/2028(3) | | |
| | | | | 31,641 | | | | | | 2,877 | | | | | | — | | | | | $ | 11.25 | | | | | | 4/21/2030(4) | | |
| | | | | 51,042 | | | | | | 18,958 | | | | | | — | | | | | $ | 33.63 | | | | | | 1/15/2031(1) | | |
| | | | | 9,583 | | | | | | 10,417 | | | | | | — | | | | | $ | 34.16 | | | | | | 1/11/2032(5) | | |
| | | | | — | | | | | | 30,000 | | | | | | — | | | | | $ | 23.30 | | | | | | 1/3/2033(2) | | |
Year
|
| |
Summary
Compensation Table Total for PEO |
| |
Compensation
Actually Paid to PEO(1) |
| |
Summary
Compensation Table Total for Non-PEO NEOs(2) |
| |
Average
Compensation Actually Paid to Non-PEO NEOs(1) |
| |
Value of
Initial Fixed $100 Investment Based on Total Shareholder Return(3) |
| |
Net Loss
(Thousands) |
| ||||||||||||||||||
2023
|
| | | $ | 2,802,021 | | | | | $ | 3,995,183 | | | | | $ | 1,300,429 | | | | | $ | 1,765,074 | | | | | $ | 115.26 | | | | | $ | (241,361) | | |
2022
|
| | | $ | 1,022,750 | | | | | $ | (1,285,896) | | | | | $ | 863,248 | | | | | $ | (488,036) | | | | | $ | 74.73 | | | | | $ | (145,226) | | |
2021
|
| | | $ | 4,682,073 | | | | | $ | 5,554,531 | | | | | $ | 2,520,785 | | | | | $ | 3,097,637 | | | | | $ | 132.45 | | | | | $ | (81,768) | | |
| | |
2023
|
| |
2022
|
| |
2021
|
| |||||||||||||||||||||||||||
| | |
PEO
|
| |
Non-PEO
NEOs (Average) |
| |
PEO
|
| |
Non-PEO
NEOs (Average) |
| |
PEO
|
| |
Non-PEO
NEOs (Average) |
| ||||||||||||||||||
Summary compensation table total
|
| | | $ | 2,802,021 | | | | | $ | 1,300,429 | | | | | $ | 1,022,750 | | | | | $ | 863,248 | | | | | $ | 4,682,073 | | | | | $ | 2,520,785 | | |
Less: Grant date fair value of option awards granted during the year
|
| | | $ | (1,706,771) | | | | | $ | (597,370) | | | | | $ | — | | | | | $ | (245,664) | | | | | $ | (3,687,792) | | | | | $ | (1,949,867) | | |
Adjusted fair value of equity awards(i) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Fair value at year-end of awards granted during the year that are outstanding and unvested
|
| | | $ | 2,704,000 | | | | | $ | 946,400 | | | | | $ | — | | | | | $ | 158,600 | | | | | $ | 4,560,250 | | | | | $ | 2,411,167 | | |
Change in fair value at year-end of awards granted in prior years that are outstanding and unvested from prior year-end
|
| | | $ | 296,889 | | | | | $ | 179,360 | | | | | $ | (1,252,138) | | | | | $ | (578,496) | | | | | $ | — | | | | | $ | 240,359 | | |
Change in fair value at vesting date of
equity awards granted in prior years that vested during the year from prior year-end |
| | | $ | (100,956) | | | | | $ | (63,745) | | | | | $ | (1,056,508) | | | | | $ | (685,724) | | | | | $ | — | | | | | $ | (124,807) | | |
Compensation actually paid
|
| | | $ | 3,995,183 | | | | | $ | 1,765,074 | | | | | $ | (1,285,896) | | | | | $ | (488,036) | | | | | $ | 5,554,531 | | | | | $ | 3,097,637 | | |
Plan Category
|
| |
Number of
Securities to be Issued upon Exercise of Outstanding Options, Warrants and Rights(a) |
| |
Weighted
Average Exercise Price of Outstanding Options, Warrants and Rights(b) |
| |
Number of
Securities Remaining Available for Future Issuance under Equity Compensation Plan (Excluding Securities Reflected in Column (a))(c) |
| |||||||||
Equity compensation plans approved by security holders(1)
|
| | | | 6,493,526 | | | | | $ | 23.22 | | | | | | 532,550 | | |
Equity compensation plans not approved by security holders
|
| | | | — | | | | | | — | | | | | | — | | |
Total
|
| | | | 6,493,526 | | | | | $ | 23.22 | | | | | | 532,550(2) | | |
Purchaser
|
| |
Shares of
Common Stock |
| |
Warrant Shares
Underlying Pre-Funded Warrant |
| |
Aggregate
Purchase Price |
| |||||||||
Viking Global Opportunities Illiquid Investments Sub-Master LP
|
| | | | — | | | | | | 1,038,765 | | | | | $ | 20,099,998.87 | | |
Viking Global Opportunities Drawdown (Aggregator) LP
|
| | | | 511,627 | | | | | | — | | | | | $ | 9,899,982.45 | | |
RA Capital Healthcare Fund, L.P.
|
| | | | 870,340 | | | | | | 2,747,245 | | | | | $ | 69,999,995.03 | | |
Perceptive Life Sciences Master Fund, Ltd.
|
| | | | 688,960 | | | | | | 2,928,626 | | | | | $ | 69,999,996.24 | | |
| | |
Beneficial Ownership(1)
|
| |||||||||
Name and Address of Beneficial Owner
|
| |
Number of
Shares Beneficially Owned |
| |
Percentage of
Shares Beneficially Owned |
| ||||||
Principal Stockholders: | | | | | | | | | | | | | |
Inhibrx, Inc.(2)
|
| | | | 1,139,147 | | | | | | 8.0% | | |
Entities affiliated with Viking Global Opportunities Illiquid Investments Sub-Master LP(3)
|
| | | | 1,787,705 | | | | | | 12.6% | | |
Entities affiliated with RA Capital Healthcare Fund, L.P(4)
|
| | | | 1,183,342 | | | | | | 8.3% | | |
Entities affiliated with Perceptive Life Sciences Master Fund, Ltd.(5)
|
| | | | 1,462,500 | | | | | | 9.9% | | |
Entities affiliated with BlackRock, Inc.(6).
|
| | | | 678,918 | | | | | | 4.8% | | |
Named Executive Officers and Directors: | | | | | | | | | | | | | |
Mark P. Lappe(7)
|
| | | | 761,413 | | | | | | 5.4% | | |
Brendan P. Eckelman, Ph.D.(8)
|
| | | | 588,888 | | | | | | 4.1% | | |
Kelly D. Deck, C.P.A.
|
| | | | — | | | | | | *% | | |
Jon Faiz Kayyem, Ph.D.(9)
|
| | | | 818,575 | | | | | | 5.8% | | |
Douglas G. Forsyth(10)
|
| | | | 149,564 | | | | | | 1.1% | | |
Kimberly Manhard
|
| | | | — | | | | | | *% | | |
Kristiina Vuori, M.D., Ph.D.
|
| | | | — | | | | | | *% | | |
All current directors and executive officers as a group (7 persons)
|
| | | | 2,318,440 | | | | | | 16.3% | | |
| | |
Page
|
| |||
| | | | F-3 | | | |
| | | | F-4 | | | |
| | | | F-5 | | | |
| | | | F-6 | | | |
| | | | F-7 | | |
| | |
Page
|
| |||
| | | | F-20 | | | |
| | | | F-22 | | | |
| | | | F-23 | | | |
| | | | F-24 | | | |
| | | | F-25 | | | |
| | | | F-26 | | |
| | |
Page
|
| |||
| | | | F-49 | | | |
| | | | F-50 | | | |
| | | | F-51 | | | |
| | | | F-52 | | | |
| | | | F-53 | | |
| | |
Page
|
| |||
| | | | F-61 | | | |
| | | | F-62 | | | |
| | | | F-63 | | | |
| | | | F-64 | | | |
| | | | F-65 | | | |
| | | | F-66 | | |
| | |
MARCH 31,
2024 |
| |
DECEMBER 31,
2023 |
| ||||||
Assets | | | | | | | | | | | | | |
Current assets: | | | | | | | | | | | | | |
Cash and cash equivalents
|
| | | $ | 252,483 | | | | | $ | 277,924 | | |
Accounts receivable
|
| | | | 171 | | | | | | 171 | | |
Other receivables
|
| | | | 2,867 | | | | | | 607 | | |
Prepaid expenses and other current assets
|
| | | | 19,017 | | | | | | 16,656 | | |
Total current assets
|
| | | | 274,538 | | | | | | 295,358 | | |
Property and equipment, net
|
| | | | 6,966 | | | | | | 6,419 | | |
Operating right-of-use asset
|
| | | | 2,487 | | | | | | 2,952 | | |
Other non-current assets
|
| | | | 4,586 | | | | | | 3,164 | | |
Total assets
|
| | | $ | 288,577 | | | | | $ | 307,893 | | |
Liabilities and stockholders’ equity | | | | | | | | | | | | | |
Current liabilities: | | | | | | | | | | | | | |
Accounts payable
|
| | | $ | 14,792 | | | | | $ | 10,954 | | |
Accrued expenses
|
| | | | 51,329 | | | | | | 43,295 | | |
Current portion of long-term debt, net of discount
|
| | | | 3,632 | | | | | | — | | |
Current portion of operating lease liability
|
| | | | 2,117 | | | | | | 2,063 | | |
Total current liabilities
|
| | | | 71,870 | | | | | | 56,312 | | |
Long-term debt, including final payment fee
|
| | | | 204,578 | | | | | | 206,968 | | |
Non-current portion of operating lease liability
|
| | | | 561 | | | | | | 1,110 | | |
Total liabilities
|
| | | | 277,009 | | | | | | 264,390 | | |
Commitments and contingencies (Note 7) | | | | | | | | | | | | | |
Stockholders’ equity | | | | | | | | | | | | | |
Preferred stock, $0.0001 par value; 15,000,000 shares authorized as of
March 31, 2024 and December 31, 2023; no shares issued or outstanding as of March 31, 2024 and December 31, 2023 |
| | | | — | | | | | | — | | |
Common stock, $0.0001 par value; 120,000,000 shares authorized as of
March 31, 2024 and December 31, 2023; 49,234,225 and 47,369,511 shares issued and outstanding as of March 31, 2024 and December 31, 2023, respectively |
| | | | 5 | | | | | | 5 | | |
Additional paid-in-capital
|
| | | | 704,007 | | | | | | 657,232 | | |
Accumulated deficit
|
| | | | (692,444) | | | | | | (613,734) | | |
Total stockholders’ equity
|
| | | | 11,568 | | | | | | 43,503 | | |
Total liabilities and stockholders’ equity
|
| | | $ | 288,577 | | | | | $ | 307,893 | | |
| | |
THREE MONTHS ENDED
MARCH 31, |
| |||||||||
| | |
2024
|
| |
2023
|
| ||||||
Revenue: | | | | | | | | | | | | | |
License fee revenue
|
| | | $ | — | | | | | $ | 17 | | |
Total revenue
|
| | | | — | | | | | | 17 | | |
Operating expenses: | | | | | | | | | | | | | |
Research and development
|
| | | | 63,851 | | | | | | 37,386 | | |
General and administrative
|
| | | | 9,974 | | | | | | 6,397 | | |
Total operating expenses
|
| | | | 73,825 | | | | | | 43,783 | | |
Loss from operations
|
| | | | (73,825) | | | | | | (43,766) | | |
Other income (expense): | | | | | | | | | | | | | |
Interest expense
|
| | | | (8,130) | | | | | | (7,563) | | |
Interest income
|
| | | | 3,304 | | | | | | 2,483 | | |
Other expense, net
|
| | | | (59) | | | | | | (70) | | |
Total other expense
|
| | | | (4,885) | | | | | | (5,150) | | |
Loss before income tax expense
|
| | | | (78,710) | | | | | | (48,916) | | |
Provision for income taxes
|
| | | | — | | | | | | — | | |
Net loss
|
| | | | (78,710) | | | | | | (48,916) | | |
Net loss per share, basic and diluted
|
| | | $ | (1.44) | | | | | $ | (1.12) | | |
Weighted-average shares of common stock and pre-funded warrants outstanding,
basic and diluted |
| | | | 54,554 | | | | | | 43,575 | | |
| | |
Common Stock
(Shares) |
| |
Common Stock
(Amount) |
| |
Additional
Paid-In Capital |
| |
Accumulated
Deficit |
| |
Total
Stockholders’ Equity |
| |||||||||||||||
Balance as of December 31, 2023
|
| | | | 47,369 | | | | | $ | 5 | | | | | $ | 657,232 | | | | | $ | (613,734) | | | | | $ | 43,503 | | |
Stock-based compensation expense
|
| | | | — | | | | | | — | | | | | | 6,397 | | | | | | — | | | | | | 6,397 | | |
Issuance of shares upon exercise of stock options
|
| | | | 1,865 | | | | | | — | | | | | | 40,378 | | | | | | — | | | | | | 40,378 | | |
Net loss
|
| | | | — | | | | | | — | | | | | | — | | | | | | (78,710) | | | | | | (78,710) | | |
Balance as of March 31, 2024
|
| | | | 49,234 | | | | | $ | 5 | | | | | $ | 704,007 | | | | | $ | (692,444) | | | | | $ | 11,568 | | |
| | |
Common Stock
(Shares) |
| |
Common Stock
(Amount) |
| |
Additional
Paid-In Capital |
| |
Accumulated
Deficit |
| |
Total
Stockholders’ Equity |
| |||||||||||||||
Balance as of December 31, 2022
|
| | | | 43,564 | | | | | $ | 4 | | | | | $ | 430,426 | | | | | $ | (372,373) | | | | | $ | 58,057 | | |
Stock-based compensation expense
|
| | | | — | | | | | | — | | | | | | 5,636 | | | | | | — | | | | | | 5,636 | | |
Issuance of shares upon exercise of stock options
|
| | | | 31 | | | | | | — | | | | | | 356 | | | | | | — | | | | | | 356 | | |
Net loss
|
| | | | — | | | | | | — | | | | | | — | | | | | | (48,916) | | | | | | (48,916) | | |
Balance as of March 31, 2023
|
| | | | 43,595 | | | | | $ | 4 | | | | | $ | 436,418 | | | | | $ | (421,289) | | | | | $ | 15,133 | | |
| | |
THREE MONTHS ENDED
MARCH 31, |
| |||||||||
| | |
2024
|
| |
2023
|
| ||||||
Cash flows from operating activities | | | | | | | | | | | | | |
Net loss
|
| | | $ | (78,710) | | | | | $ | (48,916) | | |
Adjustments to reconcile net loss to net cash used in operating activities: | | | | | | | | | | | | | |
Depreciation and amortization
|
| | | | 360 | | | | | | 295 | | |
Accretion of debt discount and non-cash interest expense
|
| | | | 1,242 | | | | | | 1,196 | | |
Stock-based compensation expense
|
| | | | 6,397 | | | | | | 5,636 | | |
Non-cash lease expense
|
| | | | 465 | | | | | | 427 | | |
Loss on disposal of fixed assets
|
| | | | — | | | | | | 2 | | |
Changes in operating assets and liabilities:
|
| | | | | | | | | | | | |
Accounts receivable
|
| | | | — | | | | | | (61) | | |
Other receivables
|
| | | | (610) | | | | | | — | | |
Receivables from related parties
|
| | | | — | | | | | | 14 | | |
Prepaid expenses and other current assets
|
| | | | (2,361) | | | | | | (2,848) | | |
Other non-current assets
|
| | | | (1,422) | | | | | | — | | |
Accounts payable
|
| | | | 4,050 | | | | | | 2,332 | | |
Accrued expenses
|
| | | | 8,034 | | | | | | 2,442 | | |
Operating lease liability
|
| | | | (495) | | | | | | (446) | | |
Deferred revenue, current portion
|
| | | | — | | | | | | (17) | | |
Net cash used in operating activities
|
| | | | (63,050) | | | | | | (39,944) | | |
Cash flows from investing activities | | | | | | | | | | | | | |
Purchase of fixed assets
|
| | | | (1,119) | | | | | | (23) | | |
Net cash used in investing activities
|
| | | | (1,119) | | | | | | (23) | | |
Cash flows from financing activities | | | | | | | | | | | | | |
Proceeds from the exercise of stock options
|
| | | | 38,728 | | | | | | 356 | | |
Net cash provided by financing activities
|
| | | | 38,728 | | | | | | 356 | | |
Net decrease in cash and cash equivalents
|
| | | | (25,441) | | | | | | (39,611) | | |
Cash and cash equivalents at beginning of period
|
| | | | 277,924 | | | | | | 273,865 | | |
Cash and cash equivalents at end of period
|
| | | $ | 252,483 | | | | | $ | 234,254 | | |
Supplemental schedule of non-cash investing and financing activities | | | | | | | | | | | | | |
Payable for purchase of fixed assets
|
| | | $ | 307 | | | | | $ | 258 | | |
Receivable for proceeds from the exercise of stock options
|
| | | $ | 1,650 | | | | | $ | — | | |
| | |
THREE MONTHS
ENDED MARCH 31, |
| |||||||||
| | |
2024
|
| |
2023
|
| ||||||
Outstanding stock options
|
| | | | 6,042 | | | | | | 5,785 | | |
Warrants to purchase common stock
|
| | | | 47 | | | | | | 47 | | |
Total
|
| | | | 6,089 | | | | | | 5,832 | | |
| | |
AS OF
MARCH 31, 2024 |
| |
AS OF
DECEMBER 31, 2023 |
| ||||||
Clinical drug substance and product manufacturing(1)
|
| | | $ | 8,510 | | | | | $ | 9,888 | | |
Clinical trials(2)
|
| | | | 8,372 | | | | | | 5,409 | | |
Licenses
|
| | | | 1,044 | | | | | | 728 | | |
Outside research and development services(3)
|
| | | | 552 | | | | | | 265 | | |
Other
|
| | | | 539 | | | | | | 366 | | |
Prepaid expense and other current assets
|
| | | $ | 19,017 | | | | | $ | 16,656 | | |
| | |
AS OF
MARCH 31, 2024 |
| |
AS OF
DECEMBER 31, 2023 |
| ||||||
Machinery and equipment
|
| | | $ | 8,519 | | | | | $ | 8,480 | | |
Furniture, fixtures, and other
|
| | | | 542 | | | | | | 540 | | |
Leasehold improvements
|
| | | | 795 | | | | | | 441 | | |
Computer software
|
| | | | 53 | | | | | | 53 | | |
Construction in process(1)
|
| | | | 4,088 | | | | | | 3,592 | | |
Total property and equipment
|
| | | | 13,997 | | | | | | 13,106 | | |
Less: accumulated depreciation and amortization
|
| | | | (7,031) | | | | | | (6,687) | | |
Property and equipment, net
|
| | | $ | 6,966 | | | | | $ | 6,419 | | |
| | |
THREE MONTHS
ENDED MARCH 31, |
| |||||||||
| | |
2024
|
| |
2023
|
| ||||||
Research and development
|
| | | $ | 256 | | | | | $ | 237 | | |
General and administrative
|
| | | | 104 | | | | | | 58 | | |
Total depreciation and amortization expense
|
| | | $ | 360 | | | | | $ | 295 | | |
| | |
AS OF
MARCH 31, 2024 |
| |
AS OF
DECEMBER 31, 2023 |
| ||||||
Clinical drug substance and product manufacturing(1)
|
| | | $ | 29,912 | | | | | $ | 22,805 | | |
Clinical trials(2)
|
| | | | 14,105 | | | | | | 9,224 | | |
Other outside research and development(3)
|
| | | | 1,144 | | | | | | 1,129 | | |
Interest expense
|
| | | | 2,344 | | | | | | 2,348 | | |
Compensation-related
|
| | | | 2,100 | | | | | | 6,506 | | |
Professional fees
|
| | | | 1,318 | | | | | | 780 | | |
Other
|
| | | | 406 | | | | | | 503 | | |
Accrued expenses
|
| | | $ | 51,329 | | | | | $ | 43,295 | | |
| | |
AS OF
MARCH 31, 2024 |
| |||
2025
|
| | | $ | 86,956 | | |
2026
|
| | | | 104,348 | | |
2027
|
| | | | 26,696 | | |
Total future minimum payments
|
| | | | 218,000 | | |
Less: unamortized debt discount
|
| | | | (9,790) | | |
Total debt
|
| | | $ | 208,210 | | |
Expiration Date
|
| |
Shares of Common Stock Issuable
Upon Exercise of Warrants |
| |
Exercise Price
per Share |
| ||||||
July 15, 2030
|
| | | | 7,354 | | | | | $ | 17.00 | | |
February 18, 2032
|
| | | | 40,000 | | | | | $ | 45.00 | | |
| | |
AS OF
MARCH 31, 2024 |
| |
AS OF
DECEMBER 31, 2023 |
| ||||||
Options to purchase common stock issued and outstanding
|
| | | | 4,623 | | | | | | 6,494 | | |
Shares available for future equity grants
|
| | | | 2,432 | | | | | | 533 | | |
Pre-funded warrants issued and outstanding
|
| | | | 6,715 | | | | | | 6,715 | | |
Warrants issued and outstanding
|
| | | | 47 | | | | | | 47 | | |
Total common stock reserved for future issuance
|
| | | | 13,817 | | | | | | 13,789 | | |
| | |
Number of
Shares |
| |
Weighted
Average Exercise Price |
| |
Weighted
Average Remaining Contractual Term (In Years) |
| |
Aggregate
Intrinsic Value |
| ||||||||||||
Outstanding as of December 31, 2023
|
| | | | 6,494 | | | | | $ | 23.22 | | | | | | | | | | | | | | |
Exercised
|
| | | | (1,865) | | | | | $ | 21.65 | | | | | | | | | | | | | | |
Forfeited
|
| | | | (6) | | | | | $ | 32.97 | | | | | | | | | | | | | | |
Outstanding as of March 31, 2024
|
| | | | 4,623 | | | | | $ | 23.84 | | | | | | 7.6 | | | | | $ | 52,413 | | |
Vested and exercisable as of March 31, 2024
|
| | | | 1,892 | | | | | $ | 22.84 | | | | | | 6.3 | | | | | $ | 23,474 | | |
| | |
THREE MONTHS
ENDED MARCH 31, 2023 |
| |||
Risk-free interest rate
|
| | | | 3.81% | | |
Expected volatility
|
| | | | 84.31% | | |
Expected dividend yield
|
| | | | —% | | |
Expected term (in years)
|
| | | | 6.08 | | |
Weighted average fair value
|
| | | $ | 17.95 | | |
| | |
THREE MONTHS
ENDED MARCH 31, |
| |||||||||
| | |
2024
|
| |
2023
|
| ||||||
Research and development
|
| | | $ | 4,192 | | | | | $ | 3,849 | | |
General and administrative
|
| | | | 2,205 | | | | | | 1,787 | | |
Total stock-based compensation expense
|
| | | $ | 6,397 | | | | | $ | 5,636 | | |
| | |
AS OF
MARCH 31, 2024 |
| |
AS OF
DECEMBER 31, 2023 |
| ||||||
Operating right-of-use asset
|
| | | $ | 2,487 | | | | | $ | 2,952 | | |
Operating lease liability | | | | | | | | | | | | | |
Current
|
| | | $ | 2,117 | | | | | $ | 2,063 | | |
Non-current
|
| | | | 561 | | | | | $ | 1,110 | | |
Total operating lease liability
|
| | | $ | 2,678 | | | | | $ | 3,173 | | |
| | |
AS OF
MARCH 31, 2024 |
| |||
2024
|
| | | | 1,690 | | |
2025
|
| | | | 1,137 | | |
Thereafter
|
| | | | — | | |
Total future minimum lease payments
|
| | | $ | 2,827 | | |
Less: imputed interest
|
| | | | (149) | | |
Present value of operating lease liability
|
| | | | 2,678 | | |
Less: current portion of operating lease liability
|
| | | | (2,117) | | |
Non-current portion of operating lease liability
|
| | | $ | 561 | | |
| | |
AS OF DECEMBER 31,
|
| |||||||||
| | |
2023
|
| |
2022
|
| ||||||
Assets | | | | | | | | | | | | | |
Current assets: | | | | | | | | | | | | | |
Cash and cash equivalents
|
| | | $ | 277,924 | | | | | $ | 273,865 | | |
Accounts receivable
|
| | | | 778 | | | | | | 243 | | |
Receivables from related parties
|
| | | | — | | | | | | 14 | | |
Prepaid expenses and other current assets
|
| | | | 16,656 | | | | | | 6,371 | | |
Total current assets
|
| | | | 295,358 | | | | | | 280,493 | | |
Property and equipment, net
|
| | | | 6,419 | | | | | | 2,501 | | |
Operating right-of-use asset
|
| | | | 2,952 | | | | | | 4,717 | | |
Other non-current assets
|
| | | | 3,164 | | | | | | 3,164 | | |
Total assets
|
| | | $ | 307,893 | | | | | $ | 290,875 | | |
Liabilities and stockholders’ equity | | | | | | | | | | | | | |
Current liabilities: | | | | | | | | | | | | | |
Accounts payable
|
| | | $ | 10,954 | | | | | $ | 8,326 | | |
Accrued expenses
|
| | | | 43,295 | | | | | | 17,224 | | |
Deferred revenue
|
| | | | — | | | | | | 166 | | |
Current portion of lease liability
|
| | | | 2,063 | | | | | | 1,860 | | |
Total current liabilities
|
| | | | 56,312 | | | | | | 27,576 | | |
Long-term debt, including final payment fee
|
| | | | 206,968 | | | | | | 202,069 | | |
Non-current portion of lease liability
|
| | | | 1,110 | | | | | | 3,173 | | |
Total liabilities
|
| | | | 264,390 | | | | | | 232,818 | | |
Commitments and contingencies (Note 9) | | | | | | | | | | | | | |
Stockholders’ equity: | | | | | | | | | | | | | |
Preferred stock, $0.0001 par value, 15,000,000 shares authorized and no shares outstanding as of December 31, 2023 and December 31, 2022
|
| | | | — | | | | | | — | | |
Common stock, $0.0001 par value, 120,000,000 shares authorized as of December 31, 2023 and December 31, 2022; 47,369,511 and 43,564,283 shares issued and outstanding as of December 31, 2023 and December 31, 2022, respectively
|
| | | | 5 | | | | | | 4 | | |
Additional paid-in-capital
|
| | | | 657,232 | | | | | | 430,426 | | |
Accumulated deficit
|
| | | | (613,734) | | | | | | (372,373) | | |
Total stockholders’ equity
|
| | | | 43,503 | | | | | | 58,057 | | |
Total liabilities and stockholders’ equity
|
| | | $ | 307,893 | | | | | $ | 290,875 | | |
| | |
YEAR ENDED
DECEMBER 31, |
| |||||||||
| | |
2023
|
| |
2022
|
| ||||||
Revenue: | | | | | | | | | | | | | |
License fee revenue
|
| | | $ | 1,800 | | | | | $ | 2,178 | | |
Grant revenue
|
| | | | — | | | | | | 14 | | |
Total revenue
|
| | | | 1,800 | | | | | | 2,192 | | |
Operating expenses: | | | | | | | | | | | | | |
Research and development
|
| | | | 191,640 | | | | | | 110,186 | | |
General and administrative
|
| | | | 29,381 | | | | | | 21,123 | | |
Total operating expenses
|
| | | | 221,021 | | | | | | 131,309 | | |
Loss from operations
|
| | | | (219,221) | | | | | | (129,117) | | |
Other income (expense): | | | | | | | | | | | | | |
Interest expense
|
| | | | (31,840) | | | | | | (18,181) | | |
Interest income
|
| | | | 11,917 | | | | | | 2,074 | | |
Other income (expense), net
|
| | | | (580) | | | | | | 1 | | |
Total other expense
|
| | | | (20,503) | | | | | | (16,106) | | |
Loss before provision for income taxes
|
| | | | (239,724) | | | | | | (145,223) | | |
Provision for income taxes
|
| | | | 3 | | | | | | 3 | | |
Loss on equity method investment
|
| | | | 1,634 | | | | | | — | | |
Net loss
|
| | | $ | (241,361) | | | | | $ | (145,226) | | |
Net loss per share, basic and diluted
|
| | | $ | (5.12) | | | | | $ | (3.62) | | |
Weighted-average shares of common stock outstanding, basic and diluted
|
| | | | 47,130 | | | | | | 40,108 | | |
| | |
Common Stock
(Shares) |
| |
Common Stock
(Amount) |
| |
Additional
Paid-In Capital |
| |
Accumulated
Deficit |
| |
Total
Stockholders’ Equity |
| |||||||||||||||
Balance as of December 31, 2021
|
| | | | 38,991 | | | | | $ | 4 | | | | | $ | 279,526 | | | | | $ | (227,147) | | | | | $ | 52,383 | | |
Stock-based compensation expense
|
| | | | — | | | | | | — | | | | | | 20,450 | | | | | | — | | | | | | 20,450 | | |
Issuance of shares upon exercise of stock options
|
| | | | 241 | | | | | | — | | | | | | 2,757 | | | | | | — | | | | | | 2,757 | | |
Issuance of shares, net of issuance costs
|
| | | | 4,332 | | | | | | — | | | | | | 126,981 | | | | | | — | | | | | | 126,981 | | |
Issuance of warrants
|
| | | | — | | | | | | — | | | | | | 712 | | | | | | — | | | | | | 712 | | |
Net loss
|
| | | | — | | | | | | — | | | | | | — | | | | | | (145,226) | | | | | | (145,226) | | |
Balance as of December 31, 2022
|
| | | | 43,564 | | | | | $ | 4 | | | | | $ | 430,426 | | | | | $ | (372,373) | | | | | $ | 58,057 | | |
Stock-based compensation expense
|
| | | | — | | | | | | — | | | | | | 24,846 | | | | | | — | | | | | | 24,846 | | |
Issuance of shares upon exercise of stock options
|
| | | | 184 | | | | | | — | | | | | | 2,316 | | | | | | — | | | | | | 2,316 | | |
Issuance of common stock and pre-funded warrants in private placement, net of issuance costs
|
| | | | 3,621 | | | | | | 1 | | | | | | 199,644 | | | | | | — | | | | | | 199,645 | | |
Net loss
|
| | | | — | | | | | | — | | | | | | — | | | | | | (241,361) | | | | | | (241,361) | | |
Balance as of December 31, 2023
|
| | | | 47,369 | | | | | $ | 5 | | | | | $ | 657,232 | | | | | $ | (613,734) | | | | | $ | 43,503 | | |
| | |
YEAR ENDED
DECEMBER 31, |
| |||||||||
| | |
2023
|
| |
2022
|
| ||||||
Cash flows from operating activities | | | | | | | | | | | | | |
Net loss
|
| | | $ | (241,361) | | | | | $ | (145,226) | | |
Adjustments to reconcile net loss to net cash used in operating activities:
|
| | | | | | | | | | | | |
Depreciation and amortization
|
| | | | 1,191 | | | | | | 1,225 | | |
Accretion of debt discount and non-cash interest expense
|
| | | | 4,899 | | | | | | 3,448 | | |
Stock-based compensation expense
|
| | | | 24,846 | | | | | | 20,450 | | |
Non-cash lease expense
|
| | | | 1,765 | | | | | | 1,621 | | |
Loss from equity method investment
|
| | | | 1,634 | | | | | | — | | |
Non-cash license revenue
|
| | | | (1,634) | | | | | | — | | |
Loss on disposal of fixed assets
|
| | | | 3 | | | | | | 19 | | |
Changes in operating assets and liabilities:
|
| | | | | | | | | | | | |
Accounts receivable
|
| | | | (535) | | | | | | 130 | | |
Receivables from related parties
|
| | | | 14 | | | | | | 491 | | |
Prepaid expenses and other current assets
|
| | | | (10,285) | | | | | | 612 | | |
Other non-current assets
|
| | | | — | | | | | | (1,317) | | |
Accounts payable
|
| | | | 2,109 | | | | | | (705) | | |
Accrued expenses
|
| | | | 26,071 | | | | | | 7,603 | | |
Operating lease liability
|
| | | | (1,860) | | | | | | (1,674) | | |
Deferred revenue, current portion
|
| | | | (166) | | | | | | (1,868) | | |
Deferred revenue, non-current portion
|
| | | | — | | | | | | (110) | | |
Net cash used in operating activities
|
| | | | (193,309) | | | | | | (115,301) | | |
Cash flows from investing activities | | | | | | | | | | | | | |
Purchase of fixed assets
|
| | | | (4,593) | | | | | | (686) | | |
Net cash used in investing activities
|
| | | | (4,593) | | | | | | (686) | | |
Cash flows from financing activities | | | | | | | | | | | | | |
Proceeds from issuance of common stock and pre-funded warrants in private placement
|
| | | | 200,000 | | | | | | — | | |
Issuance costs associated with issuance of common stock and pre-funded warrants in private placement
|
| | | | (355) | | | | | | — | | |
Proceeds from ATM offering
|
| | | | — | | | | | | 127,371 | | |
Costs associated with ATM offering
|
| | | | — | | | | | | (390) | | |
Proceeds from the issuance of debt
|
| | | | — | | | | | | 128,863 | | |
Payment of fees associated with debt
|
| | | | — | | | | | | (50) | | |
Proceeds from exercise of stock options
|
| | | | 2,316 | | | | | | 2,757 | | |
Net cash provided by financing activities
|
| | | | 201,961 | | | | | | 258,551 | | |
Net increase in cash
|
| | | | 4,059 | | | | | | 142,564 | | |
Cash and cash equivalents at beginning of period
|
| | | | 273,865 | | | | | | 131,301 | | |
Cash and cash equivalents at end of period
|
| | | $ | 277,924 | | | | | $ | 273,865 | | |
Supplemental disclosure of cash flow information | | | | | | | | | | | | | |
Cash paid for interest
|
| | | $ | 26,717 | | | | | $ | 13,090 | | |
Cash paid for income taxes
|
| | | $ | 3 | | | | | $ | 4 | | |
Supplemental schedule of non-cash investing and financing activities | | | | | | | | | | | | | |
Payable for purchase of fixed assets
|
| | | $ | 519 | | | | | $ | — | | |
Fair value of warrants issued to lender in conjunction with February 2022 Amendment (as defined in Note 3)
|
| | | $ | — | | | | | $ | 712 | | |
| | |
YEAR ENDED
DECEMBER 31, |
| |||||||||
| | |
2023
|
| |
2022
|
| ||||||
Outstanding stock options
|
| | | | 6,336 | | | | | | 5,018 | | |
Warrant to purchase common stock
|
| | | | 47 | | | | | | 45 | | |
| | | | | 6,383 | | | | | | 5,063 | | |
| | |
AS OF
DECEMBER 31, |
| |||||||||
| | |
2023
|
| |
2022
|
| ||||||
Clinical drug substance and product manufacturing(1)
|
| | | $ | 9,888 | | | | | $ | 1,171 | | |
Clinical trials(2)
|
| | | | 5,409 | | | | | | 4,294 | | |
Licenses
|
| | | | 728 | | | | | | 493 | | |
Outside research and development services(3)
|
| | | | 265 | | | | | | 232 | | |
Other
|
| | | | 366 | | | | | | 181 | | |
Prepaid expense and other current assets
|
| | | $ | 16,656 | | | | | $ | 6,371 | | |
| | |
AS OF
DECEMBER 31, |
| |||||||||
| | |
2023
|
| |
2022
|
| ||||||
Machinery and equipment
|
| | | $ | 8,480 | | | | | $ | 7,023 | | |
Furniture, fixtures and other
|
| | | | 540 | | | | | | 524 | | |
Leasehold improvements
|
| | | | 441 | | | | | | 441 | | |
Computer software
|
| | | | 53 | | | | | | 53 | | |
Construction in process(1)
|
| | | | 3,592 | | | | | | — | | |
Total property and equipment
|
| | | | 13,106 | | | | | | 8,041 | | |
Less: accumulated depreciation and amortization
|
| | | | (6,687) | | | | | | (5,540) | | |
Property and equipment, net
|
| | | $ | 6,419 | | | | | $ | 2,501 | | |
| | |
YEAR ENDED
DECEMBER 31, |
| |||||||||
| | |
2023
|
| |
2022
|
| ||||||
Research and development
|
| | | $ | 992 | | | | | $ | 1,003 | | |
General and administrative
|
| | | | 199 | | | | | | 222 | | |
Total depreciation and amortization expense
|
| | | $ | 1,191 | | | | | $ | 1,225 | | |
| | |
AS OF
DECEMBER 31, |
| |||||||||
| | |
2023
|
| |
2022
|
| ||||||
Clinical drug substance and product manufacturing(1)
|
| | | $ | 22,805 | | | | | $ | 5,381 | | |
Clinical trials(2)
|
| | | | 9,224 | | | | | | 4,527 | | |
Compensation expense
|
| | | | 6,506 | | | | | | 3,374 | | |
Interest expense
|
| | | | 2,348 | | | | | | 2,124 | | |
Other outside research and development(3)
|
| | | | 1,129 | | | | | | 1,164 | | |
Professional fees
|
| | | | 780 | | | | | | 428 | | |
Other
|
| | | | 503 | | | | | | 226 | | |
Accrued expenses
|
| | | $ | 43,295 | | | | | $ | 17,224 | | |
| | |
AS OF
DECEMBER 31, 2023 |
| |||
2025
|
| | | $ | 86,956 | | |
2026
|
| | | | 104,348 | | |
2027
|
| | | | 26,696 | | |
Total future minimum payments
|
| | | | 218,000 | | |
Less: unamortized debt discount
|
| | | | (11,032) | | |
Total debt
|
| | | $ | 206,968 | | |
Expiration Date
|
| |
Shares of Common Stock Issuable
Upon Exercise of Warrants |
| |
Exercise Price
per Share |
| ||||||
July 15, 2030
|
| | | | 7,354 | | | | | $ | 17.00 | | |
February 18, 2032
|
| | | | 40,000 | | | | | $ | 45.00 | | |
| | |
AS OF
DECEMBER 31, |
| |||||||||
| | |
2023
|
| |
2022
|
| ||||||
Options to purchase common stock issued and outstanding
|
| | | | 6,494 | | | | | | 5,305 | | |
Shares available for future equity grants
|
| | | | 533 | | | | | | 162 | | |
Pre-funded warrants issued and outstanding
|
| | | | 6,715 | | | | | | — | | |
Warrants issued and outstanding
|
| | | | 47 | | | | | | 47 | | |
Total common stock reserved for future issuance
|
| | | | 13,789 | | | | | | 5,514 | | |
| | |
Number of
Shares |
| |
Weighted
Average Exercise Price |
| |
Weighted
Average Remaining Contractual Term (In Years) |
| |
Aggregate
Intrinsic Value |
| ||||||||||||
Outstanding as of December 31, 2022
|
| | | | 5,305 | | | | | $ | 22.95 | | | | | | | | | | | | | | |
Granted
|
| | | | 1,615 | | | | | $ | 22.98 | | | | | | | | | | | | | | |
Forfeited
|
| | | | (242) | | | | | $ | 23.88 | | | | | | | | | | | | | | |
Exercised
|
| | | | (184) | | | | | $ | 12.59 | | | | | | | | | | | | | | |
Outstanding as of December 31, 2023
|
| | | | 6,494 | | | | | $ | 23.22 | | | | | | 7.6 | | | | | $ | 96,548 | | |
Vested and exercisable as of December 31, 2023
|
| | | | 3,322 | | | | | $ | 21.80 | | | | | | 6.6 | | | | | $ | 54,101 | | |
| | |
YEAR ENDED
DECEMBER 31, |
| |||||||||
| | |
2023
|
| |
2022
|
| ||||||
Risk-free interest rate
|
| | | | 3.77% | | | | | | 2.63% | | |
Expected volatility
|
| | | | 84.31% | | | | | | 85.26% | | |
Expected dividend yield
|
| | | | —% | | | | | | —% | | |
Expected term
|
| | | | 6.08 | | | | | | 6.08 | | |
Weighted average fair value
|
| | | $ | 16.88 | | | | | $ | 17.72 | | |
| | |
YEAR ENDED
DECEMBER 31, |
| |||||||||
| | |
2023
|
| |
2022
|
| ||||||
Research and development
|
| | | $ | 16,630 | | | | | $ | 14,513 | | |
General and administrative
|
| | | | 8,216 | | | | | | 5,937 | | |
Total stock-based compensation expense
|
| | | $ | 24,846 | | | | | $ | 20,450 | | |
| | |
YEAR ENDED
DECEMBER 31, |
| |||||||||
| | |
2023
|
| |
2022
|
| ||||||
License fee revenue | | | | | | | | | | | | | |
Phylaxis BioScience, LLC
|
| | | $ | 1,634 | | | | | $ | 1,101 | | |
Chiesi Farmaceutici S.p.A.
|
| | | | 166 | | | | | | 877 | | |
2seventy bio, Inc.
|
| | | | — | | | | | | 200 | | |
Total license fee revenue
|
| | | | 1,800 | | | | | | 2,178 | | |
Grant revenue | | | | | | | | | | | | | |
Congressionally Directed Medical Research Program
|
| | | | — | | | | | | 14 | | |
Total grant revenue
|
| | | | — | | | | | | 14 | | |
Total revenue
|
| | | $ | 1,800 | | | | | $ | 2,192 | | |
| | |
YEAR ENDED
DECEMBER 31, |
| |||||||||
| | |
2023
|
| |
2022
|
| ||||||
Current expense: | | | | | | | | | | | | | |
State
|
| | | $ | 3 | | | | | $ | 3 | | |
Total current expense
|
| | | $ | 3 | | | | | $ | 3 | | |
| | |
YEAR ENDED
DECEMBER 31, |
| |||||||||
| | |
2023
|
| |
2022
|
| ||||||
Expected income tax benefit at federal statutory rate
|
| | | $ | (50,684) | | | | | $ | (30,497) | | |
State income tax expense (benefit), net of federal benefit
|
| | | | (3,568) | | | | | | (2,495) | | |
Permanent items
|
| | | | 1,524 | | | | | | 583 | | |
R&D credits
|
| | | | (2,322) | | | | | | (1,261) | | |
Unrecognized tax benefits (FIN 48)
|
| | | | 1,054 | | | | | | 751 | | |
Return to provision true-ups
|
| | | | (420) | | | | | | (135) | | |
Valuation allowance
|
| | | | 54,419 | | | | | | 33,057 | | |
Income tax expense
|
| | | $ | 3 | | | | | $ | 3 | | |
| | |
AS OF
DECEMBER 31, |
| |||||||||
| | |
2023
|
| |
2022
|
| ||||||
Deferred income tax assets | | | | | | | | | | | | | |
Net operating loss carryforward
|
| | | $ | 68,254 | | | | | $ | 52,970 | | |
Research and development credits
|
| | | | 12,648 | | | | | | 9,728 | | |
Intangibles
|
| | | | 3,289 | | | | | | 3,684 | | |
Accruals
|
| | | | 1,412 | | | | | | 696 | | |
Stock compensation
|
| | | | 8,581 | | | | | | 5,130 | | |
Capitalized research and development costs
|
| | | | 51,772 | | | | | | 19,585 | | |
Deferred revenue
|
| | | | — | | | | | | 37 | | |
Operating lease liabilities
|
| | | | 697 | | | | | | 1,118 | | |
Other
|
| | | | 10 | | | | | | — | | |
Gross deferred tax assets
|
| | | | 146,663 | | | | | | 92,948 | | |
Less: Valuation allowance
|
| | | | (146,005) | | | | | | (91,586) | | |
Total deferred tax assets
|
| | | | 658 | | | | | | 1,362 | | |
Deferred income tax liabilities | | | | | | | | | | | | | |
Fixed assets
|
| | | | (10) | | | | | | (35) | | |
Operating lease right-of-use assets
|
| | | | (648) | | | | | | (1,048) | | |
Other
|
| | | | — | | | | | | (279) | | |
Total deferred tax liabilities
|
| | | | (658) | | | | | | (1,362) | | |
Net deferred tax assets (liabilities)
|
| | | $ | — | | | | | $ | — | | |
| | |
AS OF
DECEMBER 31, |
| |||||||||
| | |
2023
|
| |
2022
|
| ||||||
Beginning balance
|
| | | $ | 3,597 | | | | | $ | 2,846 | | |
Increases related to current year tax positions
|
| | | | 1,054 | | | | | | 751 | | |
Ending balance
|
| | | $ | 4,651 | | | | | $ | 3,597 | | |
| | |
AS OF
DECEMBER 31, |
| |||||||||
| | |
2023
|
| |
2022
|
| ||||||
Operating right-of-use asset
|
| | | $ | 2,952 | | | | | $ | 4,717 | | |
Operating lease liability | | | | | | | | | | | | | |
Current
|
| | | | 2,063 | | | | | | 1,860 | | |
Non-current
|
| | | | 1,110 | | | | | | 3,173 | | |
Total operating lease liability
|
| | | $ | 3,173 | | | | | $ | 5,033 | | |
| | |
AS OF
DECEMBER 31, 2023 |
| |||
2024
|
| | | $ | 2,247 | | |
2025
|
| | | | 1,137 | | |
Total future minimum lease payments
|
| | | $ | 3,384 | | |
Less: imputed interest
|
| | | | (211) | | |
Present value of operating lease liability
|
| | | | 3,173 | | |
Less: current portion of operating lease liability
|
| | | | (2,063) | | |
Non-current portion of operating lease liability
|
| | | $ | 1,110 | | |
| | |
MARCH 31,
2024 |
| |
DECEMBER 31,
2023 |
| ||||||
Assets | | | | | | | | | | | | | |
Current assets: | | | | | | | | | | | | | |
Accounts receivable
|
| | | $ | 171 | | | | | $ | 171 | | |
Other receivables
|
| | | | 133 | | | | | | 607 | | |
Prepaid expenses and other current assets
|
| | | | 13,879 | | | | | | 12,687 | | |
Total current assets
|
| | | | 14,183 | | | | | | 13,465 | | |
Property and equipment, net
|
| | | | 6,966 | | | | | | 6,419 | | |
Operating right-of-use asset
|
| | | | 2,487 | | | | | | 2,952 | | |
Other non-current assets
|
| | | | 4,586 | | | | | | 3,164 | | |
Total assets
|
| | | $ | 28,222 | | | | | $ | 26,000 | | |
Liabilities and stockholders’ equity | | | | | | | | | | | | | |
Current liabilities: | | | | | | | | | | | | | |
Accounts payable
|
| | | $ | 12,367 | | | | | $ | 8,311 | | |
Accrued expenses
|
| | | | 23,947 | | | | | | 22,489 | | |
Current portion of operating lease liability
|
| | | | 2,117 | | | | | | 2,063 | | |
Total current liabilities
|
| | | | 38,431 | | | | | | 32,863 | | |
Non-current portion of operating lease liability
|
| | | | 561 | | | | | | 1,110 | | |
Total liabilities
|
| | | | 38,992 | | | | | | 33,973 | | |
Commitments and contingencies (Note 4) | | | | | | | | | | | | | |
Stockholders’ equity | | | | | | | | | | | | | |
Net parent investment
|
| | | | (10,770) | | | | | | (7,973) | | |
Total equity
|
| | | | (10,770) | | | | | | (7,973) | | |
Total liabilities and equity
|
| | | $ | 28,222 | | | | | $ | 26,000 | | |
| | |
THREE MONTHS ENDED
MARCH 31, |
| |||||||||
| | |
2024
|
| |
2023
|
| ||||||
Operating expenses: | | | | | | | | | | | | | |
Research and development
|
| | | $ | 40,432 | | | | | $ | 34,207 | | |
General and administrative
|
| | | | 8,782 | | | | | | 5,334 | | |
Total operating expenses
|
| | | | 49,214 | | | | | | 39,541 | | |
Loss from operations
|
| | | | (49,214) | | | | | | (39,541) | | |
Other income (expense): | | | | | | | | | | | | | |
Other expense, net
|
| | | | (59) | | | | | | (70) | | |
Total other expense
|
| | | | (59) | | | | | | (70) | | |
Loss before income tax expense
|
| | | | (49,273) | | | | | | (39,611) | | |
Net loss
|
| | | $ | (49,273) | | | | | $ | (39,611) | | |
| | |
Net Parent
Investment |
| |||
Balance as of December 31, 2023
|
| | | $ | (7,973) | | |
Stock-based compensation expense
|
| | | | 5,043 | | |
Net loss
|
| | | | (49,273) | | |
Net transfers from Parent
|
| | | | 41,433 | | |
Balance as of March 31, 2024
|
| | | $ | (10,770) | | |
| | |
Net Parent
Investment |
| |||
Balance as of December 31, 2022
|
| | | $ | (7,300) | | |
Stock-based compensation expense
|
| | | | 4,690 | | |
Net loss
|
| | | | (39,611) | | |
Net transfers from Parent
|
| | | | 26,962 | | |
Balance as of March 31, 2023
|
| | | $ | (15,259) | | |
| | |
THREE MONTHS ENDED
MARCH 31, |
| |||||||||
| | |
2024
|
| |
2023
|
| ||||||
Cash flows from operating activities | | | | | | | | | | | | | |
Net loss
|
| | | $ | (49,273) | | | | | $ | (39,611) | | |
Adjustments to reconcile net loss to net cash used in operating activities: | | | | | | | | | | | | | |
Depreciation and amortization
|
| | | | 360 | | | | | | 295 | | |
Stock-based compensation expense
|
| | | | 5,043 | | | | | | 4,690 | | |
Non-cash lease expense
|
| | | | 465 | | | | | | 427 | | |
Loss on disposal of fixed assets
|
| | | | — | | | | | | 2 | | |
Changes in operating assets and liabilities:
|
| | | | | | | | | | | | |
Accounts receivable
|
| | | | 474 | | | | | | (61) | | |
Receivables from related parties
|
| | | | — | | | | | | 14 | | |
Prepaid expenses and other current assets
|
| | | | (1,192) | | | | | | 47 | | |
Other non-current assets
|
| | | | (1,422) | | | | | | — | | |
Accounts payable
|
| | | | 4,268 | | | | | | 5,248 | | |
Accrued expenses
|
| | | | 1,458 | | | | | | 2,456 | | |
Operating lease liability
|
| | | | (495) | | | | | | (446) | | |
Net cash used in operating activities
|
| | | | (40,314) | | | | | | (26,939) | | |
Cash flows from investing activities | | | | | | | | | | | | | |
Purchase of fixed assets
|
| | | | (1,119) | | | | | | (23) | | |
Net cash used in investing activities
|
| | | | (1,119) | | | | | | (23) | | |
Cash flows from financing activities | | | | | | | | | | | | | |
Net transfers from Parent
|
| | | | 41,433 | | | | | | 26,962 | | |
Net cash provided by financing activities
|
| | | | 41,433 | | | | | | 26,962 | | |
Net increase in cash and cash equivalents
|
| | | | — | | | | | | — | | |
Cash and cash equivalents at beginning of period
|
| | | | — | | | | | | — | | |
Cash and cash equivalents at end of period
|
| | | $ | — | | | | | $ | — | | |
Supplemental schedule of non-cash investing and financing activities | | | | | | | | | | | | | |
Payable for purchase of fixed assets
|
| | | $ | 307 | | | | | $ | 258 | | |
| | |
AS OF
MARCH 31, 2024 |
| |
AS OF
DECEMBER 31, 2023 |
| ||||||
Clinical drug substance and product manufacturing(1)
|
| | | $ | 8,306 | | | | | $ | 9,627 | | |
Clinical trials(2)
|
| | | | 3,592 | | | | | | 1,701 | | |
Licenses
|
| | | | 1,044 | | | | | | 728 | | |
Outside research and development services(3)
|
| | | | 398 | | | | | | 265 | | |
Other
|
| | | | 539 | | | | | | 366 | | |
Prepaid expense and other current assets
|
| | | $ | 13,879 | | | | | $ | 12,687 | | |
| | |
AS OF
MARCH 31, 2024 |
| |
AS OF
DECEMBER 31, 2023 |
| ||||||
Machinery and equipment
|
| | | $ | 8,519 | | | | | $ | 8,480 | | |
Leasehold improvements
|
| | | | 795 | | | | | | 441 | | |
Furniture, fixtures, and other
|
| | | | 542 | | | | | | 540 | | |
Computer software
|
| | | | 53 | | | | | | 53 | | |
Construction in process(1)
|
| | | | 4,088 | | | | | | 3,592 | | |
Total property and equipment
|
| | | | 13,997 | | | | | | 13,106 | | |
Less: accumulated depreciation and amortization
|
| | | | (7,031) | | | | | | (6,687) | | |
Property and equipment, net
|
| | | $ | 6,966 | | | | | $ | 6,419 | | |
| | |
THREE MONTHS ENDED
MARCH 31, |
| |||||||||
| | |
2024
|
| |
2023
|
| ||||||
Research and development
|
| | | $ | 256 | | | | | $ | 237 | | |
General and administrative
|
| | | | 104 | | | | | | 58 | | |
Total depreciation and amortization expense
|
| | | $ | 360 | | | | | $ | 295 | | |
| | |
AS OF
MARCH 31, 2024 |
| |
AS OF
DECEMBER 31, 2023 |
| ||||||
Deposits related to clinical trials(1)
|
| | | $ | 4,341 | | | | | $ | 2,919 | | |
Deposits related to operating leases
|
| | | | 245 | | | | | | 245 | | |
Other non-current assets
|
| | | $ | 4,586 | | | | | $ | 3,164 | | |
| | |
AS OF
MARCH 31, 2024 |
| |
AS OF
DECEMBER 31, 2023 |
| ||||||
Clinical trials(1)
|
| | | $ | 14,105 | | | | | $ | 9,224 | | |
Clinical drug substance and product manufacturing(2)
|
| | | | 5,169 | | | | | | 4,554 | | |
Compensation expense
|
| | | | 2,100 | | | | | | 6,506 | | |
Other outside research and development(3)
|
| | | | 849 | | | | | | 922 | | |
Professional fees
|
| | | | 1,318 | | | | | | 780 | | |
Other
|
| | | | 406 | | | | | | 503 | | |
Accrued expenses
|
| | | $ | 23,947 | | | | | $ | 22,489 | | |
| | |
THREE MONTHS ENDED
MARCH 31, |
| |||||||||
| | |
2024
|
| |
2023
|
| ||||||
Research and development
|
| | | $ | 3,098 | | | | | $ | 3,192 | | |
General and administrative
|
| | | | 1,945 | | | | | | 1,498 | | |
Total stock-based compensation expense
|
| | | $ | 5,043 | | | | | $ | 4,690 | | |
| | |
AS OF
MARCH 31, 2024 |
| |
AS OF
DECEMBER 31, 2023 |
| ||||||
Operating right-of-use asset
|
| | | $ | 2,487 | | | | | $ | 2,952 | | |
Operating lease liability | | | | | | | | | | | | | |
Current
|
| | | $ | 2,117 | | | | | $ | 2,063 | | |
Non-current
|
| | | | 561 | | | | | $ | 1,110 | | |
Total operating lease liability
|
| | | $ | 2,678 | | | | | $ | 3,173 | | |
| | |
AS OF
MARCH 31, 2024 |
| |||
2024
|
| | | | 1,690 | | |
2025
|
| | | | 1,137 | | |
Thereafter
|
| | | | — | | |
Total future minimum lease payments
|
| | | $ | 2,827 | | |
Less: imputed interest
|
| | | | (149) | | |
Present value of operating lease liability
|
| | | | 2,678 | | |
Less: current portion of operating lease liability
|
| | | | (2,117) | | |
Non-current portion of operating lease liability
|
| | | $ | 561 | | |
| | |
THREE MONTHS ENDED
MARCH 31, |
| |||||||||
| | |
2024
|
| |
2023
|
| ||||||
Research and development
|
| | | $ | 11,794 | | | | | $ | 11,325 | | |
General and administrative
|
| | | | 6,201 | | | | | | 4,254 | | |
Total allocated operating expenses
|
| | | $ | 17,995 | | | | | $ | 15,579 | | |
| | |
THREE MONTHS ENDED
MARCH 31, |
| |||||||||
| | |
2024
|
| |
2023
|
| ||||||
General financing activities
|
| | | $ | 23,438 | | | | | $ | 11,383 | | |
Allocations of Parent’s corporate expenses
|
| | | | 17,995 | | | | | | 15,579 | | |
Total net transfers from Parent per condensed combined statements of equity and condensed combined statements of cash flows
|
| | | $ | 41,433 | | | | | $ | 26,962 | | |
| | |
AS OF DECEMBER 31,
|
| |||||||||
| | |
2023
|
| |
2022
|
| ||||||
Assets | | | | | | | | | | | | | |
Current assets: | | | | | | | | | | | | | |
Accounts receivable
|
| | | $ | 778 | | | | | $ | 243 | | |
Receivables from related parties
|
| | | | — | | | | | | 14 | | |
Prepaid expenses and other current assets
|
| | | | 12,687 | | | | | | 6,006 | | |
Total current assets
|
| | | | 13,465 | | | | | | 6,263 | | |
Property and equipment, net
|
| | | | 6,419 | | | | | | 2,501 | | |
Operating right-of-use asset
|
| | | | 2,952 | | | | | | 4,717 | | |
Other non-current assets
|
| | | | 3,164 | | | | | | 3,164 | | |
Total assets
|
| | | $ | 26,000 | | | | | $ | 16,645 | | |
Liabilities and equity | | | | | | | | | | | | | |
Current liabilities: | | | | | | | | | | | | | |
Accounts payable
|
| | | $ | 8,311 | | | | | $ | 4,343 | | |
Accrued expenses
|
| | | | 22,489 | | | | | | 14,569 | | |
Current portion of lease liability
|
| | | | 2,063 | | | | | | 1,860 | | |
Total current liabilities
|
| | | | 32,863 | | | | | | 20,772 | | |
Non-current portion of lease liability
|
| | | | 1,110 | | | | | | 3,173 | | |
Total liabilities
|
| | | | 33,973 | | | | | | 23,945 | | |
Commitments and contingencies (Note 7) | | | | | | | | | | | | | |
Equity: | | | | | | | | | | | | | |
Net parent investment
|
| | | | (7,973) | | | | | | (7,300) | | |
Total equity
|
| | | | (7,973) | | | | | | (7,300) | | |
Total liabilities and equity
|
| | | $ | 26,000 | | | | | $ | 16,645 | | |
| | |
YEAR ENDED
DECEMBER 31, |
| |||||||||
| | |
2023
|
| |
2022
|
| ||||||
Revenue: | | | | | | | | | | | | | |
License fee revenue
|
| | | $ | 1,634 | | | | | $ | 1,301 | | |
Grant revenue
|
| | | | — | | | | | | 14 | | |
Total revenue
|
| | | | 1,634 | | | | | | 1,315 | | |
Operating expenses: | | | | | | | | | | | | | |
Research and development
|
| | | | 130,133 | | | | | | 101,603 | | |
General and administrative
|
| | | | 24,248 | | | | | | 15,035 | | |
Total operating expenses
|
| | | | 154,381 | | | | | | 116,638 | | |
Loss from operations
|
| | | | (152,747) | | | | | | (115,323) | | |
Other income (expense): | | | | | | | | | | | | | |
Other income (expense), net
|
| | | | (580) | | | | | | 1 | | |
Total other income (expense)
|
| | | | (580) | | | | | | 1 | | |
Loss before provision for income taxes
|
| | | | (153,327) | | | | | | (115,322) | | |
Provision for income taxes
|
| | | | 3 | | | | | | 3 | | |
Loss on equity method investment
|
| | | | 1,634 | | | | | | — | | |
Net loss
|
| | | $ | (154,964) | | | | | $ | (115,325) | | |
| | |
Net Parent
Investment |
| |||
Balance as of December 31, 2021
|
| | | $ | (1,313) | | |
Stock-based compensation expense
|
| | | | 17,791 | | |
Net loss
|
| | | | (115,325) | | |
Net transfers from Parent
|
| | | | 91,547 | | |
Balance as of December 31, 2022
|
| | | | (7,300) | | |
Stock-based compensation expense
|
| | | | 20,691 | | |
Net loss
|
| | | | (154,964) | | |
Net transfers from Parent
|
| | | | 133,600 | | |
Balance as of December 31, 2023
|
| | | $ | (7,973) | | |
| | |
YEAR ENDED
DECEMBER 31, |
| |||||||||
| | |
2023
|
| |
2022
|
| ||||||
Cash flows from operating activities | | | | | | | | | | | | | |
Net loss
|
| | | $ | (154,964) | | | | | $ | (115,325) | | |
Adjustments to reconcile net loss to net cash used in operating activities:
|
| | | | | | | | | | | | |
Depreciation and amortization
|
| | | | 1,191 | | | | | | 1,225 | | |
Stock-based compensation expense
|
| | | | 20,691 | | | | | | 17,791 | | |
Non-cash lease expense
|
| | | | 1,765 | | | | | | 1,621 | | |
Loss from equity method investment
|
| | | | 1,634 | | | | | | — | | |
Non-cash license revenue
|
| | | | (1,634) | | | | | | — | | |
Loss on disposal of fixed assets
|
| | | | 3 | | | | | | 19 | | |
Changes in operating assets and liabilities:
|
| | | | | | | | | | | | |
Accounts receivable
|
| | | | (535) | | | | | | 130 | | |
Receivables from related parties
|
| | | | 14 | | | | | | 491 | | |
Prepaid expenses and other current assets
|
| | | | (6,681) | | | | | | 407 | | |
Other non-current assets
|
| | | | — | | | | | | (1,317) | | |
Accounts payable
|
| | | | 3,449 | | | | | | (378) | | |
Accrued expenses
|
| | | | 7,920 | | | | | | 7,301 | | |
Operating lease liability
|
| | | | (1,860) | | | | | | (1,674) | | |
Deferred revenue, current portion
|
| | | | — | | | | | | (1,102) | | |
Net cash used in operating activities
|
| | | | (129,007) | | | | | | (90,811) | | |
Cash flows from investing activities | | | | | | | | | | | | | |
Purchase of fixed assets
|
| | | | (4,593) | | | | | | (686) | | |
Net cash used in investing activities
|
| | | | (4,593) | | | | | | (686) | | |
Cash flows from financing activities | | | | | | | | | | | | | |
Net transfers from Parent
|
| | | | 133,600 | | | | | | 91,497 | | |
Net cash provided by financing activities
|
| | | | 133,600 | | | | | | 91,497 | | |
Net increase in cash
|
| | | | — | | | | | | — | | |
Cash and cash equivalents at beginning of period
|
| | | | — | | | | | | — | | |
Cash and cash equivalents at end of period
|
| | | $ | — | | | | | $ | — | | |
Supplemental disclosure of cash flow information | | | | | | | | | | | | | |
Cash paid for income taxes
|
| | | $ | 3 | | | | | $ | 4 | | |
Supplemental schedule of non-cash investing and financing activities | | | | | | | | | | | | | |
Payable for purchase of fixed assets
|
| | | $ | 519 | | | | | $ | — | | |
| | |
AS OF DECEMBER 31,
|
| |||||||||
| | |
2023
|
| |
2022
|
| ||||||
Clinical drug substance and product manufacturing(1)
|
| | | $ | 9,627 | | | | | $ | 806 | | |
Clinical trials(2)
|
| | | | 1,701 | | | | | | 4,294 | | |
Licenses
|
| | | | 728 | | | | | | 493 | | |
Outside research and development services(3)
|
| | | | 265 | | | | | | 232 | | |
Other
|
| | | | 366 | | | | | | 181 | | |
Prepaid expense and other current assets
|
| | | $ | 12,687 | | | | | $ | 6,006 | | |
| | |
AS OF DECEMBER 31,
|
| |||||||||
| | |
2023
|
| |
2022
|
| ||||||
Machinery and equipment
|
| | | $ | 8,480 | | | | | $ | 7,023 | | |
Furniture, fixtures and other
|
| | | | 540 | | | | | | 524 | | |
Leasehold improvements
|
| | | | 441 | | | | | | 441 | | |
Computer software
|
| | | | 53 | | | | | | 53 | | |
Construction in process(1)
|
| | | | 3,592 | | | | | | — | | |
Total property and equipment
|
| | | | 13,106 | | | | | | 8,041 | | |
Less: accumulated depreciation and amortization
|
| | | | (6,687) | | | | | | (5,540) | | |
Property and equipment, net
|
| | | $ | 6,419 | | | | | $ | 2,501 | | |
| | |
YEAR ENDED DECEMBER 31,
|
| |||||||||
| | |
2023
|
| |
2022
|
| ||||||
Research and development
|
| | | $ | 992 | | | | | $ | 1,003 | | |
General and administrative
|
| | | | 199 | | | | | | 222 | | |
Total depreciation and amortization expense
|
| | | $ | 1,191 | | | | | $ | 1,225 | | |
| | |
AS OF DECEMBER 31,
|
| |||||||||
| | |
2023
|
| |
2022
|
| ||||||
Clinical trials(1)
|
| | | $ | 9,224 | | | | | $ | 4,384 | | |
Compensation expense
|
| | | | 6,506 | | | | | | 3,374 | | |
Clinical drug substance and product manufacturing(2)
|
| | | | 4,554 | | | | | | 5,110 | | |
Other outside research and development(3)
|
| | | | 922 | | | | | | 1,047 | | |
Professional fees
|
| | | | 780 | | | | | | 428 | | |
Other
|
| | | | 503 | | | | | | 226 | | |
Accrued expenses
|
| | | $ | 22,489 | | | | | $ | 14,569 | | |
| | |
YEAR ENDED DECEMBER 31,
|
| |||||||||
| | |
2023
|
| |
2022
|
| ||||||
Research and development
|
| | | $ | 13,801 | | | | | $ | 13,496 | | |
General and administrative
|
| | | | 6,890 | | | | | | 4,295 | | |
Total stock-based compensation expense
|
| | | $ | 20,691 | | | | | $ | 17,791 | | |
| | |
YEAR ENDED DECEMBER 31,
|
| |||||||||
| | |
2023
|
| |
2022
|
| ||||||
License fee revenue | | | | | | | | | | | | | |
Phylaxis BioScience, LLC
|
| | | $ | 1,634 | | | | | $ | 1,101 | | |
2seventy bio, Inc.
|
| | | | — | | | | | | 200 | | |
Total license fee revenue
|
| | | | 1,634 | | | | | | 1,301 | | |
Grant revenue | | | | | | | | | | | | | |
Congressionally Directed Medical Research Program
|
| | | | — | | | | | | 14 | | |
Total grant revenue
|
| | | | — | | | | | | 14 | | |
Total revenue
|
| | | $ | 1,634 | | | | | $ | 1,315 | | |
| | |
YEAR ENDED DECEMBER 31,
|
| |||||||||
| | |
2023
|
| |
2022
|
| ||||||
Expected income tax benefit at federal statutory rate
|
| | | $ | (32,540) | | | | | $ | (24,217) | | |
State income tax expense (benefit), net of federal benefit
|
| | | | (2,516) | | | | | | (2,037) | | |
Permanent items
|
| | | | 1,265 | | | | | | 495 | | |
Return to provision true-ups
|
| | | | (420) | | | | | | (135) | | |
Attributes remaining with Parent
|
| | | | 30,752 | | | | | | 23,382 | | |
Valuation allowance
|
| | | | 3,462 | | | | | | 2,515 | | |
Income tax expense
|
| | | $ | 3 | | | | | $ | 3 | | |
| | |
AS OF DECEMBER 31,
|
| |||||||||
| | |
2023
|
| |
2022
|
| ||||||
Deferred income tax assets | | | | | | | | | | | | | |
Intangibles
|
| | | $ | 2,554 | | | | | $ | 2,862 | | |
Accruals
|
| | | | 1,412 | | | | | | 696 | | |
Stock compensation
|
| | | | 7,122 | | | | | | 4,361 | | |
Operating lease liabilities
|
| | | | 697 | | | | | | 1,118 | | |
Other
|
| | | | 10 | | | | | | — | | |
Gross deferred tax assets
|
| | | | 11,795 | | | | | | 9,037 | | |
Less: Valuation allowance
|
| | | | (11,137) | | | | | | (7,675) | | |
Total deferred tax assets
|
| | | | 658 | | | | | | 1,362 | | |
Deferred income tax liabilities | | | | | | | | | | | | | |
Fixed assets
|
| | | | (10) | | | | | | (35) | | |
Operating lease right-of-use assets
|
| | | | (648) | | | | | | (1,048) | | |
Other
|
| | | | — | | | | | | (279) | | |
Total deferred tax liabilities
|
| | | | (658) | | | | | | (1,362) | | |
Net deferred tax assets (liabilities)
|
| | | $ | — | | | | | $ | — | | |
| | |
AS OF DECEMBER 31,
|
| |||||||||
| | |
2023
|
| |
2022
|
| ||||||
Operating right-of-use asset
|
| | | $ | 2,952 | | | | | $ | 4,717 | | |
Operating lease liability | | | | | | | | | | | | | |
Current
|
| | | | 2,063 | | | | | | 1,860 | | |
Non-current
|
| | | | 1,110 | | | | | | 3,173 | | |
Total operating lease liability
|
| | | $ | 3,173 | | | | | $ | 5,033 | | |
| | |
AS OF
DECEMBER 31, |
| |||
| | |
2023
|
| |||
2024
|
| | | $ | 2,247 | | |
2025
|
| | | | 1,137 | | |
Total future minimum lease payments
|
| | | $ | 3,384 | | |
Less: imputed interest
|
| | | | (211) | | |
Present value of operating lease liability
|
| | | | 3,173 | | |
Less: current portion of operating lease liability
|
| | | | (2,063) | | |
Non-current portion of operating lease liability
|
| | | $ | 1,110 | | |
| | |
YEAR ENDED
DECEMBER 31, |
| |||||||||
| | |
2023
|
| |
2022
|
| ||||||
Research and development
|
| | | $ | 47,924 | | | | | $ | 38,995 | | |
General and administrative
|
| | | | 19,479 | | | | | | 11,357 | | |
Total allocated operating expenses
|
| | | $ | 67,403 | | | | | $ | 50,352 | | |
| | |
YEAR ENDED
DECEMBER 31, |
| |||||||||
| | |
2023
|
| |
2022
|
| ||||||
General financing activities
|
| | | $ | 66,194 | | | | | $ | 41,192 | | |
Allocations of Parent’s corporate expenses
|
| | | | 67,403 | | | | | | 50,352 | | |
Income taxes
|
| | | | 3 | | | | | | 3 | | |
Total net transfers from Parent per combined statements of equity
|
| | | $ | 133,600 | | | | | $ | 91,547 | | |
Other
|
| | | | — | | | | | | (50) | | |
Total net transfers from Parent per combined statements of cash flows
|
| | | $ | 133,600 | | | | | $ | 91,497 | | |