A U.S. Senator Just Bought this Tiny Stock - It's Up 15% Today Shuttesrtock / Gdisalvo Tommy Tuberville, a Republican Senator from the state of Alabama, disclosed 19 new stock trades on April 15th, and one trade in particular is causing big movements in the underlying stock. Tuberville reported 3 trades in Humacyte (Nasdaq: HUMA). The stock is now up 18.5% the past five days, including a 15% gain today. Let’s dive into the details of why this Congressional trade is turning heads. Humacyte is a Biotechnolo ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ___________________________________ (Mark One) x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-39532 Humacyte, Inc. (Exact name of registrant as specified in its charter) ___ ...

[Humacyte Fourth Quarter and Year End 2023 Financial Results and Business Update](index=1&type=section&id=Humacyte%20Fourth%20Quarter%20and%20Year%20End%202023%20Financial%20Results%20and%20Business%20Update) Humacyte's 2023 financial results reflect increased operating expenses and a widened net loss, while early 2024 saw significant cash bolstering [Business Update and Corporate Highlights](index=1&type=section&id=Business%20Update%20and%20Corporate%20Highlights) Humacyte achieved significant regulatory milestones in late 2023 and early 2024, highlighted by the FDA's acceptance and Priority Review of its Biologics License Application (BLA) for the Human Acellular Vessel (HAV) in vascular trauma [Clinical and Regulatory Updates](index=1&type=section&id=Clinical%20and%20Regulatory%20Updates) The FDA accepted Humacyte's BLA for the HAV in vascular trauma, granting it Priority Review with a PDUFA action date of August 10, 2024 - The FDA accepted the Biologics License Application (BLA) for the Human Acellular Vessel (HAV) for use in urgent arterial repair following extremity vascular trauma[1](index=1&type=chunk)[4](index=4&type=chunk) - The BLA was granted Priority Review, setting a Prescription Drug User Fee Act (PDUFA) action date for August 10, 2024, which shortens the review time from ten to six months[1](index=1&type=chunk)[5](index=5&type=chunk) - The BLA submission is supported by positive results from the V005 Phase 2/3 clinical trial and real-world evidence from wartime injuries in Ukraine, which showed higher rates of blood flow (patency) and lower rates of amputation and infection compared to historic synthetic graft benchmarks[4](index=4&type=chunk) - The HAV has received multiple FDA designations for the vascular trauma indication, including Regenerative Medicine Advanced Therapy (RMAT) and a priority designation from the Secretary of Defense, underscoring its potential to address a critical need[5](index=5&type=chunk) [Presentations and Publications](index=2&type=section&id=Presentations%20and%20Publications) The company presented positive results from its V005 vascular trauma trial at the VEITH Symposium, and a preclinical study on small-diameter HAV for congenital heart conditions was published - Positive results from the V005 vascular trauma trial were presented at the VEITH Symposium, highlighting higher patency and lower amputation/infection rates for the HAV compared to historical benchmarks[6](index=6&type=chunk) - A preclinical study published in a peer-reviewed journal showed the potential of the **3.5mm** small-diameter HAV to treat tetralogy of Fallot, a congenital heart defect, with the vessels remaining patent for up to six months and showing evidence of host cell repopulation[6](index=6&type=chunk) [Fourth Quarter and Full Year 2023 Financial Highlights](index=2&type=section&id=Fourth%20Quarter%20and%20Full%20Year%202023%20Financial%20Highlights) Humacyte ended 2023 with **$80.4 million** in cash, which was further bolstered by approximately **$63.1 million** in early 2024 from a public offering and an additional funding draw - The company ended 2023 with **$80.4 million** in cash and cash equivalents, a position strengthened in early 2024 by raising approximately **$43.1 million** in net proceeds from a public offering and receiving **$20 million** from a funding arrangement with Oberland Capital[1](index=1&type=chunk)[8](index=8&type=chunk) - Management believes its current cash position is adequate to finance operations for at least 12 months, extending well past the anticipated FDA PDUFA date in August 2024[8](index=8&type=chunk) [Financial Performance (Statement of Operations)](index=2&type=section&id=Financial%20Performance%20(Statement%20of%20Operations)) For the full year 2023, Humacyte reported no revenue, with increased operating expenses and a significant net loss of **$110.8 million** primarily due to a non-cash charge Financial Performance (Statement of Operations) | Financial Metric | Q4 2023 ($) | Q4 2022 ($) | FY 2023 ($) | FY 2022 ($) | | :--- | :--- | :--- | :--- | :--- | | Grant Revenue | $0 | $0 | $0 | $1.6M | | R&D Expenses | $20.2M | $15.0M | $76.6M | $63.3M | | G&A Expenses | $6.0M | $5.8M | $23.5M | $22.9M | | Loss from Operations | ($26.2M) | ($20.8M) | ($100.0M) | ($84.6M) | | Net Loss | ($25.1M) | ($3.7M) | ($110.8M) | ($12.0M) | | Net Loss Per Share | ($0.24) | ($0.04) | ($1.07) | ($0.12) | - The increase in R&D expenses in 2023 was primarily due to higher costs for personnel, external services, and materials supporting expanded R&D initiatives, clinical trials for vascular trauma (V005, V017), and the BLA filing[10](index=10&type=chunk) - The significant increase in net loss for FY 2023 was mainly driven by the non-cash remeasurement of the contingent earnout liability, which resulted in a **$10.7 million** net expense, compared to a **$72.6 million** net income in the prior year[10](index=10&type=chunk) [Financial Position (Balance Sheet)](index=2&type=section&id=Financial%20Position%20(Balance%20Sheet)) As of December 31, 2023, Humacyte reported total assets of **$128.2 million**, a decrease from 2022, with total liabilities increasing to **$114.7 million** and stockholders' equity significantly decreasing Financial Position (Balance Sheet) | Balance Sheet Item | Dec 31, 2023 ($) | Dec 31, 2022 ($) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $80.4M | $149.8M | | Total current assets | $83.3M | $154.2M | | Total assets | $128.2M | $204.3M | | **Liabilities & Equity** | | | | Total current liabilities | $18.4M | $19.6M | | Total liabilities | $114.7M | $87.4M | | Total stockholders' equity | $13.5M | $116.9M | | Total liabilities and stockholders' equity | $128.2M | $204.3M | - The decrease in cash and cash equivalents from **$149.8 million** in 2022 to **$80.4 million** in 2023 reflects the company's net cash usage of **$69.0 million** for the year to fund operations[8](index=8&type=chunk)[17](index=17&type=chunk)

Financial Data and Key Metrics Changes - Research and development expenses increased to $18.6 million for Q3 2023 from $17.3 million in Q3 2022, and for the nine months ended September 30, 2023, expenses rose to $56.4 million from $48.3 million in the same period of 2022 [13] - Net loss for Q3 2023 was $26.0 million compared to $25.3 million in Q3 2022, and for the nine months ended September 30, 2023, net loss was $85.7 million compared to $8.2 million in the same period of 2022 [14][49] - No revenue was reported for Q3 2023, down from $31,000 in Q3 2022, and for the nine months ended September 30, 2023, revenue was $1.6 million compared to $1.6 million in the same period of 2022 [28] Business Line Data and Key Metrics Changes - The Human Acellular Vessel (HAV) demonstrated a 30-day patency rate of 90% in the V005 trial, compared to approximately 81% historically for synthetic grafts [22] - The HAV showed a lower amputation rate of 9.8% compared to over 20% for synthetic grafts, and an infection rate of 2% compared to over 8% historically for synthetic grafts [6][7] Market Data and Key Metrics Changes - Approximately 70,000 vascular injuries occur annually in the U.S. requiring repair, with tens of thousands needing grafting or surgical repair [35] - The company anticipates capturing a significant portion of the synthetic graft market and potentially some vein use in traumatic injury indications [36] Company Strategy and Development Direction - The company plans to submit a Biologics Licensing Application (BLA) for the HAV in vascular trauma during the current quarter, leveraging its Regenerative Medicine Advanced Therapy (RMAT) designation for priority review [24] - The company is focusing on health economics and budget impact modeling to support the HAV's utility in trauma care, aiming to improve patient outcomes and reduce hospital expenditures [41][63] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming BLA submission and the potential for priority review due to existing designations from the FDA and the Department of Defense [24][58] - The company highlighted the positive outcomes from humanitarian efforts in Ukraine, which will be included in the BLA filing [25] Other Important Information - As of September 30, 2023, the company had cash and cash equivalents of $100 million, with a funding arrangement of up to $160 million from Oberland Capital [47] - General and administrative expenses were $6.1 million for Q3 2023, slightly down from $6.2 million in Q3 2022, with a total of $17.5 million for the nine months ended September 30, 2023, compared to $17.1 million in the same period of 2022 [48] Q&A Session Summary Question: What additional data on V005 should be expected at VEITH? - The company will share efficacy results and safety outcomes during a podium presentation at the VEITH meeting [34] Question: Can you size up the market and low-hanging fruit post-approval? - The market size includes approximately 70,000 vascular injuries annually, with a significant portion requiring grafting [35] Question: What steps remain for the BLA submission process? - The BLA is complex, but much of it is ready, with two modules largely completed [40] Question: Will there be humanitarian efforts during the Gaza conflict? - The company has not received requests from surgeons in Israel but would consider them if they arise [61] Question: How open are surgeons to trying new procedures and options? - Trauma surgeons are generally more inclined to use biologics like HAV due to the ease of use compared to harvesting veins [68] Question: What are the plans for collecting real-world evidence post-launch? - The company plans to work with key opinion leaders and capture data on HAV usage in various trauma scenarios [83]

PART I – FINANCIAL INFORMATION [Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) Presents Humacyte's unaudited condensed consolidated financial statements, including balance sheets, income statements, and cash flows, with notes on accounting policies and financing events Condensed Consolidated Balance Sheet Highlights (unaudited) | ($ in thousands) | September 30, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $99,986 | $149,772 | | Total current assets | $102,851 | $154,208 | | Total assets | $149,385 | $204,302 | | **Liabilities & Stockholders' Equity** | | | | Total current liabilities | $15,137 | $19,580 | | Contingent Earnout Liability | $39,601 | $27,893 | | Revenue interest liability | $37,286 | $— | | Total liabilities | $112,392 | $87,374 | | Total stockholders' equity | $36,993 | $116,928 | Condensed Consolidated Statements of Operations Highlights (unaudited) | ($ in thousands, except per share data) | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :--- | :--- | :--- | | Grant revenue | $— | $1,565 | | Research and development | $56,370 | $48,303 | | General and administrative | $17,495 | $17,050 | | Loss from operations | $(73,865) | $(63,788) | | Change in fair value of Contingent Earnout Liability | $(11,708) | $58,649 | | Net loss | $(85,670) | $(8,245) | | Net loss per share, basic and diluted | $(0.83) | $(0.08) | Condensed Consolidated Statements of Cash Flows Highlights (unaudited) | ($ in thousands) | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(54,251) | $(52,170) | | Net cash used in investing activities | $(23) | $(367) | | Net cash provided by (used in) financing activities | $4,842 | $(1,234) | | Net decrease in cash, cash equivalents and restricted cash | $(49,432) | $(53,771) | - The company has generated no product revenue since inception and has a history of operating losses, with an accumulated deficit of **$512.2 million** as of September 30, 2023. Management believes current cash and cash equivalents of **$100.0 million** are sufficient to fund operations for at least 12 months from the report's issuance date[29](index=29&type=chunk)[30](index=30&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=32&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Humacyte's financial performance, liquidity, and business outlook, highlighting clinical trial progress and increased R&D expenses - Humacyte is a clinical-stage company developing bioengineered human tissues (HAVs) for vascular repair, AV access for hemodialysis, and PAD. The company announced positive top-line results from its V005 Phase 2/3 trial in vascular trauma and plans to file a BLA with the FDA in the fourth quarter of 2023[167](index=167&type=chunk)[169](index=169&type=chunk) Comparison of Operating Results (Nine Months Ended Sep 30) | ($ in thousands) | 2023 | 2022 | Change (%) | | :--- | :--- | :--- | :--- | | Research and development | $56,370 | $48,303 | +17% | | General and administrative | $17,495 | $17,050 | +3% | | Loss from operations | $(73,865) | $(63,788) | +16% | | Net loss | $(85,670) | $(8,245) | +939% | - The significant increase in net loss for the nine months ended September 30, 2023, was primarily driven by a non-cash expense of **$11.7 million** from the remeasurement of the Contingent Earnout Liability, compared to a non-cash gain of **$58.6 million** in the same period of 2022, representing a negative swing of **$70.3 million**[193](index=193&type=chunk) - Research and development expenses for the nine months ended Sep 30, 2023 increased by **$8.1 million (17%)** to **$56.4 million**, driven by a **$4.8 million** increase in payroll and a **$2.4 million** increase in external services to support clinical trials and BLA filing preparations[191](index=191&type=chunk) - As of September 30, 2023, the company had **$100.0 million** in cash and cash equivalents, which is believed to be sufficient to fund operations for at least the next 12 months. In May 2023, the company secured a Revenue Interest Purchase Agreement for up to **$150.0 million** in financing, receiving an initial **$40.0 million**[195](index=195&type=chunk)[196](index=196&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=43&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) Humacyte, as a smaller reporting company, is exempt from providing quantitative and qualitative disclosures about market risk - The company qualifies as a smaller reporting company and is not required to provide quantitative and qualitative disclosures about market risk[219](index=219&type=chunk) [Controls and Procedures](index=43&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of September 30, 2023, with no material changes to internal control over financial reporting - Based on an evaluation as of September 30, 2023, the Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were effective[221](index=221&type=chunk) - No changes in internal control over financial reporting occurred during the three months ended September 30, 2023, that have materially affected, or are reasonably likely to materially affect, internal controls[222](index=222&type=chunk) PART II – OTHER INFORMATION [Legal Proceedings](index=44&type=section&id=Item%201.%20Legal%20Proceedings) The company is not aware of any legal proceedings or claims expected to materially adversely affect its business or financial condition - The Company is not aware of any legal proceedings or claims that are expected to have a material adverse effect on its business or financials[224](index=224&type=chunk) [Risk Factors](index=44&type=section&id=Item%201A.%20Risk%20Factors) No material changes to previously disclosed risk factors have occurred, except as updated in the Q2 2023 Form 10-Q - No material changes from the risk factors discussed in the Annual Report have occurred, except as noted in the Q2 2023 Form 10-Q[225](index=225&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=44&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities or use of proceeds during the period [Other Information](index=44&type=section&id=Item%205.%20Other%20Information) The company reported no other information for this item [Exhibits](index=45&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Quarterly Report, including CEO and CFO certifications and Inline XBRL financial data

Humacyte Inc. (NASDAQ:HUMA) Q2 2023 Earnings Conference Call August 14, 2023 8:00 AM ET Company Participants Dr. Laura Niklason - President & CEO Dale Sander - CFO & Chief Corporate Development Officer Dr. Heather Prichard - COO Laura Marek - LifeSci Advisors, IR Conference Call Participants Ryan Zimmerman - BTIG Josh Jennings - TD Cowen Matthew O'Brien - Piper Sandler Suraj Kalia - Oppenheimer & Company Bruce Jackson - The Benchmark Company. Operator Good morning, ladies and gentlemen, and welcome to the H ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ___________________________________________________________________________________________________________________________ FORM 10-Q (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 (State or other jurisdiction of incorporation or ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ___________________________________________________________________________________________________________________________ FORM 10-Q (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______ to ______ ...

Humacyte Inc. (NASDAQ:HUMA) Q1 2023 Results Conference Call May 12, 2023 8:00 AM ET Company Participants Lauren Marek - LifeSci Advisors Laura Niklason - Founder, President, CEO and Director Dale Sander - CFO, Chief Corporate Development Officer and Treasurer Conference Call Participants Phil Dantoin - Piper Sandler Ryan Zimmerman - BTIG Joshua Jennings - TD Cowen Suraj Kalia - Oppenheimer & Company Bruce Jackson - Benchmark Company Operator Good morning, ladies and gentlemen, and welcome to the Humacyte Fi ...

Humacyte, Inc. (NASDAQ:HUMA) Q4 2022 Earnings Conference Call March 24, 2023 8:00 AM ET Company Participants Lauren Marek - LifeSci Advisors, Investor Relations Laura Niklason - President and Chief Executive Officer Dale Sander - Chief Financial Officer and Chief Corporate Development Officer Heather Prichard - Chief Operating Officer Conference Call Participants Ryan Zimmerman - BTIG Phillip Paul Dantoin - Piper Sandler Josh Jennings - TD Cowen Suraj Kalia - Oppenheimer Bruce Jackson - The Benchmark Compan ...