Andy Roberts/OJO Images via Getty Images Topline Summary Corbus Pharmaceuticals (NASDAQ:CRBP) is a microcap biotech company focused on the development of novel therapies for the treatment of cancer. They've recently experienced a meteoric surge out of the depths on the back of a positive clinical readout, but it remains very early days for the company's overall pipeline, and cash is not sufficient to keep the ball rolling without some significant financing needed. It's best to hold off on this one for n ...

The stock of Corbus Pharmaceuticals Holdings, Inc. (NASDAQ:CRBP) closed up nearly 250% last week. The gains happened after favourable pharmaceutical news that saw the stock climb above $29. CRBP was previously trading at a meagre valuation below $7. Despite the stock trading almost 25% lower in premarket on Monday, the developments are worth attention. Corbus Pharmaceuticals is a precision oncology company seeking to help people defeat serious illnesses. The company targets very rare and serious diseases us ...

Shares of little-known Corbus Pharmaceuticals (NASDAQ:CRBP) are absolutely skyrocketing today. At the time of writing, CRBP stock is up more than 300%, as investors price in a key announcement from the company. Earlier today, Corbus announced that its next-generation antibody drug (CRB-701) showed strong safety and efficacy in a first-in-human study on its effects on cervical cancer tumors. This drug conjugate is one of three key drugs that are currently in clinical trial phases but has clearly moved up the ...

Q3W schedule of CRB-701 (SYS6002) demonstrates a 43% ORR and 71% DCR at predicted therapeutically relevant dosesAll assessable nectin-4 positive study participants with mUC and cervical cancer treated at or above this dose demonstrated some level of disease controlNo dose limiting toxicities (DLTs) have been observed to-date up to 3.6 mg/kg (cohort 6) with further escalation at 4.5 mg/kg ongoingNo cases of peripheral neuropathy or skin rash have been observed to dateCohort 6 is the first cohort selected for ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 or For the transition period from________ to_________. Corbus Pharmaceuticals Holdings, Inc. (Exact name of registrant as specified in its charter) (Former Name, Former Address and Former Fiscal Year if Changed Since Last Report): N/A Title of Each Class Exchange on Which Registered TradingSymbolNameofEach Large accelerated filer ☐ Accelerated filer ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q ☒ 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 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from________ to_________. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) 500 River Ridge Drive Norwood, MA ...

PART I - FINANCIAL INFORMATION This section presents the unaudited condensed consolidated financial statements and management's analysis for the first quarter of 2023 [Item 1. Condensed Consolidated Financial Statements](index=3&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements) This section presents Corbus Pharmaceuticals Holdings, Inc.'s unaudited condensed consolidated financial statements for Q1 2023, detailing a net loss of **$17.7 million** and decreased total assets [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to **$51.6 million** from **$66.3 million** by March 31, 2023, primarily due to reduced cash and investments, while equity significantly declined to **$16.5 million** Condensed Consolidated Balance Sheet Highlights (Unaudited) | Account | March 31, 2023 ($) | December 31, 2022 ($) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $7,324,437 | $17,002,715 | | Investments | $36,902,563 | $42,194,296 | | Total current assets | $45,864,999 | $60,181,102 | | **Total assets** | **$51,645,273** | **$66,311,940** | | **Liabilities & Equity** | | | | Total current liabilities | $14,358,947 | $12,639,938 | | Total liabilities | $35,186,321 | $33,321,923 | | Accumulated deficit | $(409,825,479) | $(392,080,667) | | **Total stockholders' equity** | **$16,458,952** | **$32,990,017** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The company reported a net loss of **$17.7 million** (or **$4.24** per share) for Q1 2023, an increase from **$9.4 million** in Q1 2022, driven by higher research and development expenses Statement of Operations Highlights (Unaudited, for the three months ended March 31) | Metric | 2023 ($) | 2022 ($) | | :--- | :--- | :--- | | Research and development | $13,388,343 | $3,286,236 | | General and administrative | $3,908,682 | $5,230,923 | | Total operating expenses | $17,297,025 | $8,517,159 | | Operating loss | $(17,297,025) | $(8,517,159) | | **Net loss** | **$(17,744,812)** | **$(9,437,242)** | | **Net loss per share, basic and diluted** | **$(4.24)** | **$(2.26)** | [Condensed Consolidated Statement of Stockholders' Equity](index=5&type=section&id=Condensed%20Consolidated%20Statement%20of%20Stockholders%27%20Equity) Stockholders' equity decreased from **$33.0 million** to **$16.5 million** by March 31, 2023, primarily due to a **$17.7 million** net loss, partially offset by stock-based compensation - The balance of stockholders' equity fell to **$16,458,952** at March 31, 2023, down from **$32,990,017** at December 31, 2022[9](index=9&type=chunk) - Key changes during the quarter included a net loss of **$17,744,812**, stock-based compensation expense of **$1,026,379**, and proceeds from the issuance of common stock upon exercise of stock options of **$129,745**[9](index=9&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities was **$15.1 million** for Q1 2023, resulting in a **$9.7 million** net decrease in cash and equivalents, bringing the period-end balance to **$8.0 million** Cash Flow Highlights (Unaudited, for the three months ended March 31) | Activity | 2023 ($) | 2022 ($) | | :--- | :--- | :--- | | Net cash used in operating activities | $(15,114,972) | $(10,615,350) | | Net cash provided by investing activities | $5,549,704 | $42,962,177 | | Net cash used in financing activities | $(113,010) | $(327,125) | | **Net (decrease) increase in cash** | **$(9,678,278)** | **$32,019,702** | | **Cash at end of period** | **$7,994,337** | **$57,696,234** | [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) These notes detail the company's precision oncology business, liquidity, accounting policies including a **1-for-30 reverse stock split**, and specifics on license agreements and compensation - The company is a precision oncology firm developing CRB-701 (ADC targeting Nectin-4), CRB-601 (anti-integrin monoclonal antibody), and seeking partners for CRB-913 (obesity treatment)[12](index=12&type=chunk) - The company expects its cash, cash equivalents, and investments of **$44.2 million** as of March 31, 2023, to be sufficient to fund operations for at least twelve months from the report's issuance[97](index=97&type=chunk) - On February 14, 2023, the company completed a **1-for-30 reverse stock split** of its common stock, with all share and per-share data retroactively adjusted[98](index=98&type=chunk)[154](index=154&type=chunk) - In Q1 2023, the company recorded a **$7.5 million** upfront license payment to CSPC and a **$1.2 million** development milestone under the UCSF License Agreement as research and development expenses[64](index=64&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=25&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's financial condition and Q1 2023 operational results, highlighting the precision oncology pipeline, increased R&D expenses due to licensing, and a cash runway extending through Q2 2024 [Overview](index=25&type=section&id=Overview) Corbus is a precision oncology company developing CRB-701 and CRB-601, seeking partners for CRB-913, and has an accumulated deficit of approximately **$409.8 million** as of March 31, 2023 - The company's precision oncology pipeline includes CRB-701 (Nectin-4 ADC) and CRB-601 (anti-αvβ8 monoclonal antibody)[186](index=186&type=chunk)[217](index=217&type=chunk) - The IND for CRB-701 has been cleared by the FDA, with plans to start a U.S. clinical trial in mid-2024, and an IND submission for CRB-601 is planned for the second half of 2023[204](index=204&type=chunk) - The company is seeking partners to fund further development of CRB-913, a CB1 inverse agonist for obesity[187](index=187&type=chunk)[217](index=217&type=chunk) [Results of Operations](index=27&type=section&id=Results%20of%20Operations) Research and development expenses increased by **$10.1 million** to **$13.4 million** in Q1 2023 due to licensing costs, while general and administrative expenses decreased by **$1.3 million** - Research and development expenses increased to **$13.4 million** in Q1 2023 from **$3.3 million** in Q1 2022, driven by a **$7.5 million** upfront payment for the CSPC License Agreement and a **$1.2 million** milestone payment under the UCSF License Agreement[224](index=224&type=chunk) - General and administrative expenses decreased to **$3.9 million** in Q1 2023 from **$5.2 million** in Q1 2022, a reduction of **$1.3 million**, attributed to lower legal costs, stock-based compensation, and insurance premiums[241](index=241&type=chunk) [Liquidity and Capital Resources](index=28&type=section&id=Liquidity%20and%20Capital%20Resources) The company's **$44.2 million** in cash and equivalents are expected to fund operations through Q2 2024, but significant additional capital will be required for future development and operations - The company's cash, cash equivalents, and marketable securities of approximately **$44.2 million** at March 31, 2023, are expected to fund operations through the second quarter of 2024[228](index=228&type=chunk) - Net cash used in operating activities for Q1 2023 was approximately **$15.1 million**[227](index=227&type=chunk) - The company will need to raise significant additional capital to continue funding operations and may be required to delay or scale back activities if funding is not secured on acceptable terms[215](index=215&type=chunk)[244](index=244&type=chunk) [Critical Accounting Policies and Estimates](index=29&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) Key accounting policies requiring significant judgment include stock-based compensation, accrued research and development expenses, and lease accounting, involving complex estimates and models - Critical accounting policies involve significant estimates for stock-based compensation, accrued research and development expenses, and right-of-use assets and lease liabilities[237](index=237&type=chunk)[247](index=247&type=chunk) - Stock-based compensation is valued using the Black-Scholes model, with key assumptions including expected volatility (**100.13%** in Q1 2023), term (**6.25 years**), and forfeiture rate (**17.64%** in Q1 2023)[180](index=180&type=chunk)[261](index=261&type=chunk) - Accrued R&D expenses are estimated based on services performed by research institutions and CROs, with payments often tied to milestones, and no significant changes to prior estimates were noted[249](index=249&type=chunk)[262](index=262&type=chunk)[263](index=263&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=31&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) This section is not applicable as the company qualifies as a smaller reporting company - Not Applicable[268](index=268&type=chunk) [Item 4. Controls and Procedures](index=31&type=section&id=Item%204.%20Controls%20and%20Procedures) Disclosure controls and procedures were deemed ineffective as of March 31, 2023, due to a material weakness in reporting accruals for licensing agreement payments - Disclosure controls and procedures were concluded to be not effective as of March 31, 2023[251](index=251&type=chunk) - A material weakness was identified in the control environment over internal control activities for processing and reporting accruals associated with upfront payments and fees in licensing agreements[253](index=253&type=chunk) PART II - OTHER INFORMATION This section provides other required information, including legal proceedings, risk factors, equity sales, and exhibits [Item 1. Legal Proceedings](index=32&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently subject to any material legal proceedings - The company is not currently subject to any material legal proceedings[279](index=279&type=chunk) [Item 1A. Risk Factors](index=32&type=section&id=Item%201A.%20Risk%20Factors) No material changes or additions to the risk factors previously disclosed in the company's 2022 Annual Report on Form 10-K have occurred - There have been no material changes to the risk factors disclosed in the company's 2022 Annual Report on Form 10-K[269](index=269&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=32&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities were reported during the period - None reported for the period[281](index=281&type=chunk) [Item 3. Defaults Upon Senior Securities](index=32&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This item is not applicable - Not applicable[271](index=271&type=chunk) [Item 4. Mine Safety Disclosures](index=32&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable - Not applicable[282](index=282&type=chunk) [Item 5. Other Information](index=32&type=section&id=Item%205.%20Other%20Information) The Board ratified the issuance of **43,836** common shares from March 2023 option exercises, which were inadvertently issued on a pre-reverse stock split basis and are undergoing a ratification process - On May 7, 2023, the Board ratified the issuance of **43,836** shares of common stock (**36,757** on March 8 and **7,079** on March 20) that were inadvertently issued on a pre-reverse stock split basis[272](index=272&type=chunk) - The issuances were deemed potentially defective corporate acts, and the company has initiated a ratification process under Section 204 of the Delaware General Corporation Law[272](index=272&type=chunk) [Item 6. Exhibits](index=33&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Quarterly Report on Form 10-Q, including CEO and CFO certifications and XBRL data files - Lists filed exhibits, including CEO/CFO certifications (Exhibits 31.1, 31.2, 32.1, 32.2) and various Inline XBRL documents[274](index=274&type=chunk)[275](index=275&type=chunk)[283](index=283&type=chunk)

In the United States and some foreign jurisdictions, there have been a number of legislative and regulatory changes and proposed changes regarding the healthcare system that could prevent or delay marketing approval for our drug candidates, restrict or regulate post-approval activities and affect our ability to profitably sell our drug candidates. Legislative and regulatory proposals have been made to expand post-approval requirements and restrict sales and promotional activities for pharmaceutical products ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 Title of Each Class Trading Symbol Name of Each Exchange on Which Registered Common Stock, par value $0.0001 per share CRBP Nasdaq Global Market FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from________ to_________. C ...

Financial Performance - Revenue from awards for the three months ended June 30, 2022, was $136,558, compared to $784,382 for the same period in 2021, indicating a decrease of about 82.6%[13] - The net loss for the three months ended June 30, 2022, was $13.25 million, compared to a net loss of $17.14 million for the same period in 2021, reflecting an improvement of about 22.1%[13] - The company reported a basic and diluted net loss per share of $0.11 for the three months ended June 30, 2022, compared to $0.15 for the same period in 2021[13] - The net loss for the second quarter of 2022 was $13,248,888, compared to a net loss of $17,138,376 for the same period in 2021, reflecting a decrease of approximately 22%[62] - For the three months ended June 30, 2022, the net loss was approximately $13.25 million, compared to a net loss of $17.14 million for the same period in 2021, representing a decrease of 22%[139] - For the six months ended June 30, 2022, the company recognized $0 in revenue, compared to $784,000 in revenue for the same period in 2021[155] Expenses and Liabilities - Total operating expenses for the three months ended June 30, 2022, were $12.34 million, down from $16.84 million in the same period of 2021, a reduction of approximately 26.5%[13] - The company incurred $5 million in litigation settlement expenses during the three months ended June 30, 2022[13] - Research and development expenses for the three months ended June 30, 2022, totaled approximately $2.5 million, a decrease of $8.77 million from $11.27 million in the same period of 2021[149] - General and administrative expenses for the three months ended June 30, 2022, were approximately $4.84 million, down from $5.57 million in the same period of 2021[151] - Research and development expenses for the six months ended June 30, 2022, were approximately $5.79 million, a decrease of $16.2 million from $21.99 million in the same period of 2021[156] - Interest expense for the three and six months ended June 30, 2022, was approximately $698,000 and $1,382,000, respectively[94] Assets and Equity - Total assets decreased from $107.73 million on December 31, 2021, to $82.07 million as of June 30, 2022, representing a decline of approximately 23.9%[10] - Total stockholders' equity decreased from $61.16 million on December 31, 2021, to $49.47 million as of June 30, 2022, a decline of approximately 19.1%[16] - Cash and cash equivalents increased slightly from $25.01 million on December 31, 2021, to $25.77 million as of June 30, 2022, an increase of approximately 3.1%[10] - Current liabilities decreased from $17.01 million on December 31, 2021, to $15.63 million as of June 30, 2022, a decline of about 8.1%[10] - As of June 30, 2022, total current assets were approximately $75.24 million, with current liabilities of approximately $15.63 million, resulting in working capital of approximately $59.61 million[162] Cash Flow - For the six months ended June 30, 2022, net cash used in operating activities was $22,844,404, a reduction from $39,338,076 in the same period of 2021[22] - Cash flows from investing activities resulted in a net cash provided of $24,265,670 for the six months ended June 30, 2022, compared to a net cash used of $70,523,241 in the same period of 2021[22] - Net cash used in operating activities for the six months ended June 30, 2022, was approximately $22.84 million[163] - Cash provided by investing activities for the six months ended June 30, 2022, totaled approximately $24.27 million, primarily related to sales and purchases of marketable securities[164] Future Outlook and Financing - The company anticipates ongoing operating losses due to costs related to research funding and development of product candidates[28] - The company will need to raise significant additional capital to fund operations and product candidate development, potentially through equity sales or debt financing[168] - Future financing availability will depend on market conditions and the progress of clinical development programs[169] - The company expects cash, cash equivalents, and marketable securities of approximately $73.3 million will be sufficient to meet operating and capital requirements into Q1 2024[167] Research and Development - The company plans to expand its pipeline in immuno-oncology through internal efforts and business development, focusing on immune modulators for various disease states[25] - The company incurred research and development expenses that are expensed as incurred, with no material adjustments to prior period estimates for clinical trials in 2022[49] - The company has not experienced significant changes in estimates of accrued research and development expenses following each reporting period[184] Legal and Settlement - The company made a $5 million settlement payment to Venn Therapeutics on May 26, 2022, resolving all claims against it[85] - Litigation settlement expense for the three months ended June 30, 2022, totaled $5 million due to a settlement with Venn Therapeutics, LLC[152] Stock and Shares - The weighted average number of common shares outstanding increased from 116.36 million in the second quarter of 2021 to 125.26 million in the second quarter of 2022[13] - As of June 30, 2022, the Company had 125,268,381 shares of common stock issued and outstanding, compared to 125,230,881 shares as of December 31, 2021[109] - The Company was authorized to sell up to $150,000,000 of shares under the August 2020 Sale Agreement, but did not sell any shares during the three and six months ended June 30, 2022[110] Investments and Securities - The Company reported total investments of $47,652,000 as of June 30, 2022, with a fair value of $47,533,000, reflecting a gross unrealized loss of $119,000[68] - The total fair value of financial assets as of June 30, 2022, was $69,316,000, with derivative liabilities amounting to $134,000[70] - The Company has classified all marketable debt securities as available-for-sale, with unrealized gains and losses reported as accumulated other comprehensive gain or loss[37] Risk Factors - The company continues to monitor the impact of the COVID-19 pandemic on its business and operations, indicating potential risks to future performance[27] - There have been no material changes in risk factors since the last annual report[196]