Scorpius Holdings(SCPX)

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Scorpius Holdings Announces Corporate Update Including Cost Optimization Initiatives, Strategic Corporate Developments, and Potential Opportunities for Expansion into Southeast Asia
GlobeNewswire News Room· 2025-05-05 00:00
Core Insights - Scorpius Holdings, Inc. is implementing a strategic restructuring initiative aimed at achieving over $6 million in annual cost savings through operational realignment and workforce reduction [1][2][3] - The company is exploring opportunities to establish a halal-certified biomanufacturing presence in Malaysia, targeting the underserved global Muslim population [4][5][6] - A new board member, Tan Sze Thuan, has been appointed to support the company's growth and global expansion strategy, particularly in Southeast Asia [7][8] Cost Optimization - The operational realignment includes a 28% reduction in headcount and the closing of North Carolina facilities to consolidate operations [2][4] - These measures are designed to improve capital efficiency while maintaining high-quality service delivery to clients [3][4] International Expansion - Scorpius is in preliminary discussions with Malaysian stakeholders to form a subsidiary focused on halal-compliant biomanufacturing [4][5] - The initiative aims to address the unmet need for halal-certified biopharmaceutical products within the 2 billion global Muslim population [5][6] Leadership and Governance - The appointment of Tan Sze Thuan is expected to enhance the company's ability to navigate partnerships and regulatory engagement in Southeast Asia [7][8] - This move aligns with the company's commitment to building a world-class board to guide its growth and international expansion [8]
Scorpius Holdings(SCPX) - 2025 Q1 - Quarterly Results
2025-05-01 20:21
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 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): April 30, 2025 Scorpius Holdings, Inc. (Exact name of registrant as specified in charter) Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of registrant under any of the following provisions: Delaware (State or other jurisdiction ...
Scorpius Holdings Provides 2024 Year-End Business Update; Implements Strategic Cost Reductions and Operational Streamlining
Globenewswire· 2025-04-30 20:05
SAN ANTONIO, April 30, 2025 (GLOBE NEWSWIRE) -- Scorpius Holdings, Inc (OTC: SCPX) (“Scorpius” or “the Company”), an integrated contract development and manufacturing organization ("CDMO”), today provided strategic, financial, and operational updates for the year ended December 31, 2024. Jeff Wolf, CEO of Scorpius Holdings, Inc., stated, "The current biotech funding environment has created real headwinds for many of our clients, particularly when it comes to advancing drug development and clinical trials. I ...
Scorpius Holdings(SCPX) - 2024 Q4 - Annual Report
2025-04-30 20:01
Part I [Business](index=7&type=section&id=Item%201.%20Business) Scorpius Holdings operates as a CDMO, providing biologics manufacturing services, having refocused its business while facing delisting, customer concentration, and a significant backlog decrease - The company is a contract development and manufacturing organization (CDMO) focused on biologics, including cell- and gene-based therapies, with its primary facility in San Antonio, TX, which began operations in September 2022[17](index=17&type=chunk) - In 2023, the company refocused on biomanufacturing, leading to the divestment of its clinical-stage oncology assets and the Elusys Therapeutics biodefense business[18](index=18&type=chunk)[38](index=38&type=chunk) - The company is exploring strategic alternatives with the assistance of Alliance Global Partners, announced in February 2025[24](index=24&type=chunk) - Trading of the company's common stock was suspended by the NYSE American in April 2025 due to low selling price, and the company expects to be delisted[19](index=19&type=chunk)[20](index=20&type=chunk)[21](index=21&type=chunk) Customer Concentration | Year | Customer A Revenue % | Customer B Revenue % | Customer C Revenue % | Customer D Revenue % (Discontinued Ops) | | :--- | :--- | :--- | :--- | :--- | | **2024** | 37% | 16% | - | - | | **2023 (Continuing Ops)** | 70% | - | 12% | - | | **2023 (Inclusive of Discontinued Ops)** | 36% | - | - | 49% | - The company's backlog decreased by **89%** to approximately **$1.1 million** as of December 31, 2024, from **$10.4 million** as of December 31, 2023[70](index=70&type=chunk) [Risk Factors](index=26&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant financial and operational risks, including persistent net losses, going concern doubts, material internal control weaknesses, customer concentration, and impending stock delisting - The company has a history of significant net losses, with **$34.3 million** in 2024 and **$46.8 million** in 2023, and an accumulated deficit of **$287.2 million** as of December 31, 2024[81](index=81&type=chunk)[87](index=87&type=chunk)[90](index=90&type=chunk) - There is substantial doubt about the company's ability to continue as a going concern, with current cash sufficient only to fund operations through April 2025, necessitating additional capital which may not be available on acceptable terms[86](index=86&type=chunk)[87](index=87&type=chunk)[88](index=88&type=chunk) - Material weaknesses have been identified in internal controls over financial reporting, including issues with IT general controls, income tax disclosure, revenue recognition, and impairment of long-lived assets[93](index=93&type=chunk)[94](index=94&type=chunk)[306](index=306&type=chunk) - The company is in payment default on its December 2024 Secured Convertible Notes as of April 30, 2025, having missed quarterly interest payments, with these notes secured by all company assets[100](index=100&type=chunk)[102](index=102&type=chunk) - The company's common stock is expected to be delisted from the NYSE American, which will adversely affect liquidity, the ability to raise capital, and the stock price[136](index=136&type=chunk)[143](index=143&type=chunk) - A significant portion of revenue comes from a limited number of customers; in 2024, two customers accounted for **53%** of total revenue, and a major customer from 2023 migrated to a larger CDMO in 2024[108](index=108&type=chunk) [Unresolved Staff Comments](index=57&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports that it has no unresolved staff comments from the SEC - There are no unresolved staff comments[172](index=172&type=chunk) [Cybersecurity](index=59&type=section&id=Item%201C.%20Cybersecurity) The company maintains a cyber risk management program overseen by management and the Board, with past incidents having no material adverse effect - The company has a cyber risk management program to identify, assess, and manage threats, utilizing third-party cybersecurity providers[173](index=173&type=chunk) - Management, with oversight from the Audit Committee and the Board of Directors, is responsible for the program, and the Audit Committee is briefed at least annually on cyber vulnerabilities and program effectiveness[174](index=174&type=chunk)[175](index=175&type=chunk) - The company acknowledges that past cybersecurity incidents have not had a material adverse effect on its business, financial condition, or operations[176](index=176&type=chunk) [Properties](index=59&type=section&id=Item%202.%20Properties) The company's principal offices and main facilities are in San Antonio, Texas, under long-term leases, with a smaller lab in New Jersey and a former office lease assigned - The company's principal offices have been moved to its San Antonio, Texas location following the assignment of its Morrisville, North Carolina lease in March 2025[177](index=177&type=chunk)[178](index=178&type=chunk)[179](index=179&type=chunk) - The company holds three significant leases in San Antonio, TX for its mammalian facility, microbial facility, and warehouse, with expiration dates in 2037 and 2038[181](index=181&type=chunk) - A lease for a small laboratory space in North Brunswick, New Jersey was amended in July 2024 to reduce square footage and is set to expire in July 2025[180](index=180&type=chunk) [Legal Proceedings](index=61&type=section&id=Item%203.%20Legal%20Proceedings) The company is not currently a party to any legal proceedings that would materially adversely affect its business or financial condition - The company is not presently a party to any material legal proceedings[183](index=183&type=chunk) [Mine Safety Disclosures](index=61&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section is not applicable to the company - Not applicable[184](index=184&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=61&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock was suspended from NYSE American and is expected to be delisted, now trading on OTC Markets Pink Limited, with no plans for future dividends - The company's common stock (ticker: SCPX) was suspended from trading on the NYSE American on April 21, 2025, and is expected to be delisted, currently trading on the OTC Markets Pink Limited exchange[186](index=186&type=chunk)[187](index=187&type=chunk)[188](index=188&type=chunk) - As of April 30, 2025, there were approximately **12** stockholders of record[190](index=190&type=chunk) - The company has never paid cash dividends and does not anticipate paying any in the foreseeable future[191](index=191&type=chunk) Equity Compensation Plan Information as of December 31, 2024 | Plan Category | Securities to be issued upon exercise of outstanding options | Weighted-average exercise price of outstanding options | Securities remaining available for future issuance | | :--- | :--- | :--- | :--- | | **Equity compensation plans approved by security holders** | 62,316 | $3.63 | 193,942 | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=64&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) The MD&A details the company's CDMO transition, declining revenue, significant net losses, and critical liquidity issues, necessitating ongoing financing and strategic alternatives - The company is exploring strategic alternatives to maximize shareholder value, announced in February 2025[203](index=203&type=chunk)[275](index=275&type=chunk) - The company has substantial doubt about its ability to continue as a going concern, with cash and investments of **$2.1 million** at April 30, 2025, sufficient to fund operations only through April 2025[233](index=233&type=chunk)[234](index=234&type=chunk)[235](index=235&type=chunk) Results of Operations (Continuing Operations) | Metric | FY 2024 | FY 2023 | | :--- | :--- | :--- | | **Revenue** | $6.2M | $7.0M | | **Cost of Revenues** | $3.2M | $2.7M | | **Research & Development Expense** | $14.3M | $20.1M | | **Selling, General & Administrative Expense** | $21.6M | $26.2M | | **Net Loss from Continuing Operations** | ($34.3M) | ($41.8M) | - Net cash used in operating activities decreased to **$26.0 million** in 2024 from **$31.5 million** in 2023[280](index=280&type=chunk) - Net cash provided by financing activities was **$25.6 million** in 2024, a significant increase from a use of **$9.0 million** in 2023, driven by proceeds from stock and debt issuances[290](index=290&type=chunk)[291](index=291&type=chunk) - In December 2024, the company issued **$13.4 million** in senior secured convertible notes and warrants, receiving net proceeds of approximately **$3.0 million** after repurchasing prior warrants and repaying other debt[210](index=210&type=chunk)[211](index=211&type=chunk) [Controls and Procedures](index=89&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were ineffective as of December 31, 2024, due to multiple material weaknesses in internal financial controls, for which remediation efforts are underway - Management concluded that disclosure controls and procedures were not effective as of December 31, 2024[296](index=296&type=chunk) - Multiple material weaknesses in internal control over financial reporting were identified as of December 31, 2024[301](index=301&type=chunk) - Specific material weaknesses include: Ineffective IT general controls (user access, segregation of duties); Inadequate design of controls for accounting for income taxes; Ineffective design of management review controls; Ineffective controls around process development revenue recognition; and Ineffective controls over identifying and recording impairments of long-lived assets[306](index=306&type=chunk) - The company is implementing remediation measures, including enhancing process controls, improving documentation, and designing new controls for income tax and revenue accounting[302](index=302&type=chunk) [Other Information](index=93&type=section&id=Item%209B.%20Other%20Information) As of April 28, 2025, the company received **$1.94 million** in net proceeds from the first tranche of a private placement for **48,755,000** common shares - As of April 28, 2025, the company received **$1.94 million** in net proceeds from the first tranche of a private placement for **48,755,000** shares of common stock[308](index=308&type=chunk) - The offering was made to accredited or qualified institutional investors under exemptions from registration provided by Section 4(a)(2) and/or Regulation S of the Securities Act[308](index=308&type=chunk) Part III [Directors, Executive Officers and Corporate Governance](index=93&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) This section details the company's leadership, board committee composition, director independence, and adopted corporate governance policies including a Code of Business Conduct and Ethics - The executive team is led by Jeffrey Wolf (Chairman, CEO, President) and William L. Ostrander (CFO, Secretary)[312](index=312&type=chunk)[313](index=313&type=chunk)[316](index=316&type=chunk) - The Board of Directors has standing Audit, Compensation, and Nominating and Governance Committees, with all members (John Monahan, Edward B. Smith, III, John K. A. Prendergast) being independent[328](index=328&type=chunk)[335](index=335&type=chunk)[336](index=336&type=chunk)[342](index=342&type=chunk) - The Board has determined that three of its four directors are independent as defined by NYSE American rules[334](index=334&type=chunk) - The company has a Code of Business Conduct and Ethics applicable to all employees and directors, and an Insider Trading Policy that prohibits hedging and pledging of company securities[349](index=349&type=chunk)[350](index=350&type=chunk) [Executive Compensation](index=103&type=section&id=Item%2011.%20Executive%20Compensation) Executive compensation for NEOs in 2024 primarily comprised base salary and performance bonuses, with no equity awards granted, while director compensation included annual cash fees and committee service fees 2024 Summary Compensation Table | Name and Principal Position | Year | Salary | Bonus | Total | | :--- | :--- | :--- | :--- | :--- | | **Jeffrey Wolf** (Chairman and CEO) | 2024 | $575,000 | $3,995 | $578,995 | | **William L. Ostrander** (CFO) | 2024 | $375,000 | $1,997 | $376,997 | - No equity-based compensation was issued to Named Executive Officers in 2024 due to the limited number of awards available for grant under the 2018 Stock Incentive Plan[366](index=366&type=chunk) - Employment agreements for the CEO and CFO were amended in August 2024 to include a special performance bonus based on new business booking goals, which were the only bonuses paid in 2024[363](index=363&type=chunk)[364](index=364&type=chunk)[376](index=376&type=chunk)[379](index=379&type=chunk) - Non-employee director compensation for 2024 included an annual cash fee of **$55,000**, plus additional fees for committee membership and chairmanship[391](index=391&type=chunk) - The company has adopted a clawback policy for the recovery of erroneously awarded incentive-based compensation from executive officers in the event of a financial restatement[388](index=388&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=116&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) As of April 30, 2025, **12,387,712** common shares were outstanding, with executive officers and directors owning less than **1%**, and **3i, LP** being the only beneficial owner above **5%** at **6.6%** - As of April 30, 2025, there were **12,387,712** shares of common stock outstanding[394](index=394&type=chunk) - All current executive officers and directors as a group (6 persons) beneficially owned **56,816** shares, representing less than **1%** of the company[397](index=397&type=chunk) - **3i, LP** is reported as a beneficial owner of **557,113** shares, or **6.6%** of the common stock, excluding shares underlying convertible notes and warrants due to a **4.99%** beneficial ownership limitation[398](index=398&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=118&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) Related party transactions primarily involve the divestiture of Elusys Therapeutics to an entity controlled by the CEO, including a convertible note and shared services agreement, with the Audit Committee overseeing such transactions and the board affirming director independence - The primary related party transaction involves the divestiture of Elusys Therapeutics to Elusys Holdings, a company controlled by CEO Jeffrey Wolf[406](index=406&type=chunk)[405](index=405&type=chunk) - As part of the divestiture, the company entered into a Shared Services Agreement to provide administrative and other services to Elusys Holdings on a transitional basis[406](index=406&type=chunk)[473](index=473&type=chunk) - The company issued a convertible promissory note for **$2.25 million** to Elusys Holdings as a post-closing covenant of the divestiture[406](index=406&type=chunk)[563](index=563&type=chunk) - The Board of Directors has determined that all directors except for CEO Jeffrey Wolf are independent under NYSE American rules[408](index=408&type=chunk) [Principal Accountant Fees and Services](index=121&type=section&id=Item%2014.%20Principal%20Accountant%20Fees%20and%20Services) This section details the audit fees billed by BDO USA, P.C. for fiscal years 2024 and 2023, with all services pre-approved by the Audit Committee Accountant Fees and Services | Fee Type | 2024 | 2023 | | :--- | :--- | :--- | | **Audit fees and expenses** | $890,166 | $702,600 | - Audit fees were for professional services for the audit and review of consolidated financial statements, issuance of consents, and review of SEC filings[410](index=410&type=chunk) - All services provided by the independent registered public accounting firm were pre-approved by the Audit Committee[410](index=410&type=chunk) Part IV [Exhibits and Financial Statement Schedules](index=122&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section lists the consolidated financial statements for 2024 and 2023, along with an extensive index of exhibits including corporate governance documents and certifications - This section contains the consolidated financial statements for the fiscal years ended December 31, 2024, and 2023[415](index=415&type=chunk) - An index of all exhibits filed with the report is included, referencing material agreements, corporate charters, compensation plans, and SEC-required certifications[417](index=417&type=chunk)[419](index=419&type=chunk)[421](index=421&type=chunk) [Form 10-K Summary](index=122&type=section&id=Item%2016.%20Form%2010-K%20Summary) This section is not applicable to the company's filing - Not applicable[414](index=414&type=chunk)
Scorpius Holdings Receives NYSE American Notice of Delisting and Reports Plans to Appeal
GlobeNewswire News Room· 2025-04-22 00:00
Core Points - Scorpius Holdings, Inc. has received notice from NYSE American regarding the commencement of delisting proceedings due to the low selling price of its common stock [1] - The company is also noncompliant with NYSE American's continued listing standards due to the failure to timely file its Form 10-K for the year ended December 31, 2024 [2] - Scorpius plans to appeal the delisting decision and request a review from the Exchange's Listings Qualifications Panel [3] - The CEO of Scorpius emphasized the company's commitment to regulatory compliance and transparency while working towards maximizing long-term shareholder value [4] Company Overview - Scorpius Holdings, Inc. is an integrated contract development and manufacturing organization (CDMO) focused on advancing biologic and cell therapy programs [4] - The company provides a range of analytical testing, process development, and manufacturing services to pharmaceutical and biotech companies from its facilities in San Antonio, TX [4]
Scorpius Holdings Engages Alliance Global Partners to Explore Strategic Alternatives
Globenewswire· 2025-02-26 13:30
Core Viewpoint - Scorpius Holdings, Inc. has engaged Alliance Global Partners to explore strategic alternatives aimed at maximizing shareholder value and evaluating potential growth opportunities in the biomanufacturing sector [1][2]. Company Overview - Scorpius Holdings, Inc. is an integrated contract development and manufacturing organization (CDMO) that focuses on advancing biologic programs. The company provides a wide range of analytical testing, process development, and manufacturing services to pharmaceutical and biotech companies from its facilities in San Antonio, TX [3]. Strategic Initiatives - The engagement with Alliance Global Partners is part of Scorpius' ongoing efforts to leverage its scientific and technical expertise to enhance its position in the biomanufacturing sector while considering various avenues for long-term growth [1][2].
Scorpius Holdings Announces Collaboration with KaloCyte to Advance Manufacturing for ErythroMer™
Globenewswire· 2025-01-22 13:30
Core Insights - Scorpius Holdings, Inc. has announced a collaboration with KaloCyte to enhance manufacturing efficiencies for KaloCyte's lead candidate, ErythroMer™, an artificial red blood cell designed to address critical blood loss situations [1][2] - The partnership aims to establish a commercial-scale manufacturing agreement, emphasizing Scorpius' commitment to making life-saving therapies widely available [1][2] Company Overview - Scorpius Holdings, Inc. is an integrated contract development and manufacturing organization (CDMO) that provides a comprehensive suite of services including analytical testing, process development, and cGMP clinical manufacturing [4] - The company operates state-of-the-art facilities in San Antonio, TX, and focuses on rapidly advancing biologic programs to the clinic and beyond [4] KaloCyte Overview - KaloCyte is a pre-clinical biotech startup developing ErythroMer™, a bioengineered artificial red blood cell substitute aimed at treating traumatic hemorrhage when stored blood is unavailable [3] - The product is designed to be a universal option for all blood types and has the potential to serve a $7 billion U.S. market [3] - KaloCyte has received $17 million in grants from DARPA and NIH, along with over $5 million in investor funding, and is seeking Series A financing for IND-enabling studies and Phase 1 clinical trials [3]
Scorpius Holdings Cancels Planned Reverse Stock Split
Globenewswire· 2025-01-17 20:13
Core Points - Scorpius Holdings, Inc. announced that its planned 1-for-20 reverse stock split will not be effectuated [1] Company Overview - Scorpius Holdings, Inc. is an integrated contract development and manufacturing organization (CDMO) focused on advancing biologic programs [2] - The company provides a wide range of analytical testing, process development, and manufacturing services to pharmaceutical and biotech companies [2] - Scorpius operates state-of-the-art facilities located in San Antonio, TX, and emphasizes transparent collaboration and high-quality biologics biomanufacturing [2]
Scorpius Holdings Launches Scorpius Ventures to Support U.S. Biotech Innovation through Flexible Equity-Based Onshoring Model
GlobeNewswire News Room· 2024-11-19 12:30
Core Viewpoint - Scorpius Holdings, Inc. has launched Scorpius Ventures, a new business unit aimed at supporting emerging biotech companies through a flexible American onshoring model, combining service fees with equity stakes to lower financial barriers for onshoring production of biologics [1][3][5] Group 1: Business Model and Strategy - Scorpius Ventures employs a hybrid model that provides capital-efficient access to cGMP manufacturing services via in-kind equity investment, allowing clients to share in growth potential [2] - The new venture aligns with the BIOSECURE Act, promoting onshore production of essential biological substances to enhance national security and economic resilience [3][5] - By prioritizing U.S.-based manufacturing, Scorpius Ventures aims to improve supply chain stability and foster domestic job growth [3] Group 2: Benefits to Partners - Biotech partners can leverage Scorpius' industry-leading CMC and manufacturing expertise, which ensures streamlined development, reduced risks, and clear communication regarding milestones and timelines [4] - The combination of operational support with a fee-and-equity model enables clients to utilize the company's manufacturing strengths to assist in their fundraising efforts [4] Group 3: Company Overview - Scorpius Holdings, Inc. is an integrated contract development and manufacturing organization (CDMO) focused on advancing biologic programs, offering a wide range of analytical testing, process development, and manufacturing services at its facilities in San Antonio, TX [6]
Scorpius Holdings(SCPX) - 2024 Q3 - Quarterly Report
2024-11-14 21:19
Revenue Performance - For the three months ended September 30, 2024, the company recognized $0.9 million in revenue, an increase from $0.7 million in the same period of 2023, primarily due to expanded CDMO services [153]. - For the nine months ended September 30, 2024, the company recognized $5.2 million in revenue, significantly up from $2.1 million in the same period of 2023, driven by expanded biomanufacturing operations [160]. Cost of Revenues - Cost of revenues for the three months ended September 30, 2024, was $0.9 million, up from $0.5 million in 2023, attributed to expanded service offerings and milestone work on multiple contracts [154]. - Cost of revenues for the nine months ended September 30, 2024, was $2.6 million, compared to $1.5 million in 2023, reflecting increased labor and material costs [161]. Research and Development Expenses - Research and development expenses decreased to $4.3 million for the three months ended September 30, 2024, from $5.2 million in 2023, with CDMO expenses increasing by $0.2 million [155]. - Research and development expenses for the nine months ended September 30, 2024, totaled $11.8 million, down from $16.6 million in 2023, with significant reductions in clinical trial expenses [162]. Selling, General and Administrative Expenses - Selling, general and administrative expenses were $5.6 million for the three months ended September 30, 2024, down from $6.1 million in 2023, primarily due to reduced consultant services and marketing expenses [157]. - Selling, general and administrative expenses decreased by $3.9 million to $15.7 million for the nine months ended September 30, 2024, compared to $19.6 million in 2023 [164]. Financing Activities - The company completed a public offering on August 19, 2024, raising approximately $14.4 million through the sale of 2,428,000 shares of common stock and pre-funded warrants [140]. - The company raised $22.3 million in net cash from financing activities during the nine months ended September 30, 2024, compared to a net cash outflow of $2.8 million in 2023 [176]. Cash Flow and Operating Activities - Net cash used in operating activities decreased by $9.8 million to $20.7 million for the nine months ended September 30, 2024, compared to $30.5 million in 2023 [174]. - Cash and cash equivalents and short-term investments were approximately $4.8 million as of September 30, 2024, but decreased to approximately $0.8 million by November 14, 2024 [167]. Accumulated Deficit and Going Concern - The accumulated deficit increased to approximately $277.8 million as of September 30, 2024, up from $254.4 million as of December 31, 2023 [169]. - The company anticipates needing to raise capital to sustain operations due to substantial doubt about its ability to continue as a going concern within one year after the financial statements are issued [167]. - The company has not generated significant revenue from operations and does not anticipate sufficient revenue in the near term to sustain operations through December 2024 [167]. Operational Developments - The company commenced operations at its San Antonio facility in September 2022, enhancing its biomanufacturing capabilities [138]. - A 1-for-200 reverse stock split was executed on July 17, 2024, reducing the number of outstanding shares from 98,827,831 to 494,138 [142]. Other Financial Metrics - Total non-operating expense was $0.8 million for the nine months ended September 30, 2024, compared to $0.2 million in 2023 [166]. - The change in fair value of contingent earn-out receivable was $1.2 million for the nine months ended September 30, 2024, due to an increase in expected value from a new contract [165]. - The company expects to incur significant commercialization expenses related to its CDMO business and manufacturing facility operations [170].