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  <p style="font-size:10pt;margin-top:9pt;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:12pt;font-family:Times New Roman;min-width:fit-content;">CURRENT REPORT</span></p>
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  <p style="font-size:10pt;margin-top:9pt;font-family:Times New Roman;margin-bottom:9pt;text-align:center;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">Securities registered pursuant to Section 12(b) of the Act:</span></p>
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    <td style="padding-top:0.01in;vertical-align:top;border-bottom:0.25pt solid;text-align:left;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;min-width:fit-content;"><br/>Title of each class</span></p></td>
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    <td style="padding-top:0.01in;vertical-align:top;border-bottom:0.25pt solid;text-align:left;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;min-width:fit-content;">Trading<br/>Symbol(s)</span></p></td>
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    <td style="padding-top:0.01in;vertical-align:top;text-align:left;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span><ix:nonNumeric id="F_82604aa3-4b10-4bc1-8828-30f35503c9cc" contextRef="C_045c787a-b23d-468b-a4ac-4def57611221" name="dei:Security12bTitle"><span style="color:#000000;white-space:pre-wrap;min-width:fit-content;">Common Stock, par value $0.0001 per share</span></ix:nonNumeric></span></p></td>
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    <td style="padding-top:0.01in;vertical-align:top;text-align:left;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span><ix:nonNumeric id="F_b1113f08-dff5-4f9b-9497-ff21d766b27e" contextRef="C_045c787a-b23d-468b-a4ac-4def57611221" name="dei:TradingSymbol"><span style="color:#000000;white-space:pre-wrap;min-width:fit-content;">CRBP</span></ix:nonNumeric></span></p></td>
    <td style="padding-top:0.01in;vertical-align:top;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="white-space:pre-wrap;min-width:fit-content;">&#160;</span></p></td>
    <td style="padding-top:0.01in;vertical-align:top;text-align:left;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span><span style="-sec-ix-hidden:F_bfe747b4-a6f7-4d04-bca9-f7a0cb3a0eaa;"><span style="color:#000000;white-space:pre-wrap;min-width:fit-content;">The Nasdaq Capital Market</span></span></span></p></td>
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  <p style="font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (&#167;&#8239;230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (&#167;&#8239;240.12b-2 of this chapter).</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> </span></p>
  <p style="font-size:10pt;margin-top:9pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">Emerging growth company </span><span style="font-size:10pt;"><ix:nonNumeric id="F_7f0d15ab-70de-437c-9938-9d7f3857371e" contextRef="C_045c787a-b23d-468b-a4ac-4def57611221" name="dei:EntityEmergingGrowthCompany" format="ixt-sec:boolballotbox"><span style="font-size:10pt;font-family:Times New Roman;">&#9744;</span></ix:nonNumeric></span></p>
  <p style="font-size:10pt;margin-top:9pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">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. </span><span style="font-size:10pt;font-family:Times New Roman;">&#9744;</span></p>
  <p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;border-bottom:2.25pt double #000000;text-align:left;"><span style="white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">&#160;</span></p>
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  <p style="font-size:10pt;margin-top:18pt;font-family:Times New Roman;margin-bottom:6pt;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">Item 7.01 Regulation FD Disclosure.</span></p>
  <p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:justify;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">On June 1, 2024, Corbus Pharmaceuticals Holdings, Inc. (the &#8220;Company&#8221;) issued a press release announcing data from the ongoing Phase 1 clinical trial for SYS6002 (CRB-701) conducted by the Company&#8217;s development partner, CSPC Pharmaceutical Group, that was presented at the American Society of Clinical Oncology Annual Conference (the &#8220;ASCO Annual Conference&#8221;) on June 1, 2024. A copy of the press release is attached hereto as Exhibit 99.1.</span></p>
  <p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:justify;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> </span></p>
  <p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:justify;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">The Company also updated its presentation used by management to describe its business. A copy of the presentation is furnished as Exhibit 99.2 and is incorporated herein by reference.</span></p>
  <p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:justify;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> </span></p>
  <p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:justify;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">The information in this Current Report on Form 8-K under Item 7.01, including the information contained in Exhibits 99.1 and 99.2, is being furnished to the Securities and Exchange Commission (the &#8220;SEC&#8221;), and shall not be deemed to be &#8220;filed&#8221; for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the &#8220;Exchange Act&#8221;), or otherwise subject to the liabilities of that section, and shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by a specific reference in such filing.</span></p>
  <p style="font-size:10pt;margin-top:18pt;font-family:Times New Roman;margin-bottom:6pt;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">Item 8.01 Other Events.</span></p>
  <p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:justify;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">On June 1, 2024, the Company announced data from the ongoing Phase 1 clinical trial of SYS6002 (CRB-701) conducted by the Company&#8217;s development partner, CSPC Pharmaceutical Group, that was presented at the ASCO Annual Conference on June 1, 2024.</span></p>
  <p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:justify;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> </span></p>
  <p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:6pt;text-align:justify;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">The Phase 1 dose escalation study is being conducted in China and is enrolling patients with advanced solid tumors who have failed or were intolerant to standard treatment. Patients were enrolled based on Nectin-4 staining with the exception of metastatic urothelial cancer (mUC) patients who were considered to be Nectin-4 positive. The study opened for enrollment in January 2023 and the data presented is through April 2024 from 25 patients reflective of seven dose levels (0.2, 0.6, 1.2, 1.8, 2.7, 3.6 &amp; 4.5 mg/Kg Q3W) and PK cohorts (2.7 and 3.6 mg/Kg).</span></p>
  <p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:6pt;text-align:justify;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">Emerging clinical safety profile:</span></p>
  <div style="margin-left:4.528%;display:flex;margin-top:6pt;justify-content:flex-start;align-items:baseline;margin-bottom:0;min-width:4.537%;text-align:justify;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:4.7521786492374725%;display:inline-flex;justify-content:flex-start;">&#8226;</span><div style="width:100%;display:inline;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">SYS6002 (CRB-701) was generally well tolerated with mainly grade 1 or 2 AEs.</span></div></div>
  <div style="margin-left:4.528%;display:flex;margin-top:6pt;justify-content:flex-start;align-items:baseline;margin-bottom:0;min-width:4.537%;text-align:justify;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:4.7521786492374725%;display:inline-flex;justify-content:flex-start;">&#8226;</span><div style="width:100%;display:inline;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">No DLTs or grade 4 or 5 AEs have been observed to date. </span></div></div>
  <div style="margin-left:4.528%;display:flex;margin-top:6pt;justify-content:flex-start;align-items:baseline;margin-bottom:0;min-width:4.537%;text-align:justify;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:4.7521786492374725%;display:inline-flex;justify-content:flex-start;">&#8226;</span><div style="width:100%;display:inline;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">Anemia and eye-related treatment emergent AEs (TEAEs) were the most common.</span></div></div>
  <div style="margin-left:4.528%;display:flex;margin-top:6pt;justify-content:flex-start;align-items:baseline;margin-bottom:0;min-width:4.537%;text-align:justify;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:4.7521786492374725%;display:inline-flex;justify-content:flex-start;">&#8226;</span><div style="width:100%;display:inline;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">One patient exhibited a grade 3 rash which lasted for eight days and did not result in a reduction or interruption in dosing (2.7 mg/Kg). Two milder cases of skin rash were recorded (grade 1 and grade 2). Both also resolved with no need for change or interruption in dosing.</span></div></div>
  <div style="margin-left:4.528%;display:flex;margin-top:6pt;justify-content:flex-start;align-items:baseline;margin-bottom:0;min-width:4.537%;text-align:justify;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:4.7521786492374725%;display:inline-flex;justify-content:flex-start;">&#8226;</span><div style="width:100%;display:inline;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">No new drug-related SAEs have been encountered since the January 2024 data update.</span></div></div>
  <div style="margin-left:4.528%;display:flex;margin-top:6pt;justify-content:flex-start;align-items:baseline;margin-bottom:0;min-width:4.537%;text-align:justify;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:4.7521786492374725%;display:inline-flex;justify-content:flex-start;">&#8226;</span><div style="width:100%;display:inline;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">To date, a single case of peripheral neuropathy (grade 1) has been reported (numb hands) associated with hypokalemia (grade 3). It resolved in parallel with the hypokalemia after ten days of combined oral and/or parenteral K</span><span style="color:#000000;white-space:pre-wrap;vertical-align:super;font-size:6.7pt;font-family:Times New Roman;min-width:fit-content;">+</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> replacement therapy.</span></div></div>
  <div style="margin-left:4.528%;display:flex;margin-top:6pt;justify-content:flex-start;align-items:baseline;margin-bottom:6pt;min-width:4.537%;text-align:justify;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:4.7521786492374725%;display:inline-flex;justify-content:flex-start;">&#8226;</span><div style="width:100%;display:inline;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">Two grade 3 corneal disorders were reported in patients who received 2.7 mg/Kg and 3.6 mg/Kg, respectively. Preventative eye measures have been introduced and no such cases have been seen so far at the 4.5 mg/Kg dose. Over 50% of patients enrolled had corneal disorders or dry eye at baseline.</span></div></div>
  <p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:6pt;text-align:justify;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">Emerging efficacy profile</span></p>
  <div style="margin-left:4.528%;display:flex;margin-top:6pt;justify-content:flex-start;align-items:baseline;margin-bottom:0;min-width:4.537%;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:4.7521786492374725%;display:inline-flex;justify-content:flex-start;">&#8226;</span><div style="width:100%;display:inline;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">Anti-tumor responses across multiple doses continue to be observed, with the &#64257;rst con&#64257;rmed stable disease at 0.6 mg/Kg and the &#64257;rst con&#64257;rmed partial response (PR), at 1.2 mg/Kg.</span></div></div>
  <div style="margin-left:4.528%;display:flex;margin-top:6pt;justify-content:flex-start;align-items:baseline;margin-bottom:0;min-width:4.537%;text-align:justify;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:4.7521786492374725%;display:inline-flex;justify-content:flex-start;">&#8226;</span><div style="width:100%;display:inline;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">To date, SYS6002 (CRB-701) resulted in 44% overall response rate (ORR) and 78% disease control rate (DCR) in mUC (n=9, 4 PRs, 1 unconfirmed)  and 43% ORR and 86% DCR in cervical cancer (n=7, 3 PRs, 1 unconfirmed).</span></div></div>
  <div style="margin-left:4.528%;display:flex;margin-top:6pt;justify-content:flex-start;align-items:baseline;margin-bottom:6pt;min-width:4.537%;text-align:justify;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:4.7521786492374725%;display:inline-flex;justify-content:flex-start;">&#8226;</span><div style="width:100%;display:inline;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">For all the tumor types combined at doses &#8805; 2.7 mg/Kg, SYS6002 (CRB-701) resulted in 40% ORR and 73% DCR (n=15, 6 PRs, 2 unconfirmed). An additional PR was confirmed at the 1.2 mg/Kg for an mUC patient. Two unconfirmed PR&#8217;s reported at ASCO-GU have since been confirmed.</span></div></div>
  <p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:6pt;text-align:justify;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">Emerging clinical pharmacology</span></p>
  <div style="margin-left:4.528%;display:flex;margin-top:6pt;justify-content:flex-start;align-items:baseline;margin-bottom:0;min-width:4.537%;text-align:justify;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:4.7521786492374725%;display:inline-flex;justify-content:flex-start;">&#8226;</span><div style="width:100%;display:inline;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">After a single IV infusion of SYS6002 (CRB-701), the exposure of ADC and MMAE generally increased in a dose proportional manner up to 2.7 mg/Kg.</span></div></div>
  <div style="margin-left:4.528%;display:flex;margin-top:6pt;justify-content:flex-start;align-items:baseline;margin-bottom:0;min-width:4.537%;text-align:justify;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:4.7521786492374725%;display:inline-flex;justify-content:flex-start;">&#8226;</span><div style="width:100%;display:inline;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">Dosing beyond the 2.7 mg/Kg level showed a leveling off of free MMAE.</span></div></div>
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  <div style="margin-left:4.528%;display:flex;margin-top:6pt;justify-content:flex-start;align-items:baseline;margin-bottom:0;min-width:4.537%;text-align:justify;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:4.7521786492374725%;display:inline-flex;justify-content:flex-start;">&#8226;</span><div style="width:100%;display:inline;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">All dose levels studied to date are showing lower average levels of free MMAE than enfortumab vedotin at the reference dose (1.25 mg/Kg dosed on days 1, 8 and 15 of a 28-day cycle). </span></div></div>
  <p style="font-size:10pt;margin-top:18pt;font-family:Times New Roman;margin-bottom:6pt;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">Item 9.01 Financial Statements and Exhibits.</span></p>
  <p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:justify;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">(d) Exhibits</span></p>
  <p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:justify;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> </span></p>
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    <td style="padding-top:0.01in;padding-left:0.01in;vertical-align:top;padding-bottom:0.01in;border-bottom:1.5pt solid #000000;padding-right:0.01in;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;min-width:fit-content;">Description</span></p></td>
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    <td style="padding-top:0.01in;padding-left:0.01in;vertical-align:top;padding-bottom:0.01in;padding-right:0.01in;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;min-width:fit-content;">99.1</span></p></td>
    <td style="padding-top:0.01in;padding-left:0.01in;vertical-align:top;padding-bottom:0.01in;padding-right:0.01in;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;min-width:fit-content;"> </span></p></td>
    <td style="padding-top:0.01in;padding-left:0.01in;vertical-align:top;padding-bottom:0.01in;padding-right:0.01in;text-align:right;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:justify;"><a href="crbp-ex99_1.htm"><span style="color:#0000ff;white-space:pre-wrap;text-decoration:underline;min-width:fit-content;">Press Release dated June 1, 2024</span></a></p></td>
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    <td style="padding-top:0.01in;padding-left:0.01in;vertical-align:top;padding-bottom:0.01in;padding-right:0.01in;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;min-width:fit-content;">99.2</span></p></td>
    <td style="padding-top:0.01in;padding-left:0.01in;vertical-align:top;padding-bottom:0.01in;padding-right:0.01in;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;min-width:fit-content;"> </span></p></td>
    <td style="padding-top:0.01in;padding-left:0.01in;vertical-align:top;padding-bottom:0.01in;padding-right:0.01in;text-align:right;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:justify;"><a href="crbp-ex99_2.htm"><span style="color:#0000ff;white-space:pre-wrap;text-decoration:underline;min-width:fit-content;">Investor Presentation</span></a></p></td>
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    <td style="padding-top:0.01in;padding-left:0.01in;vertical-align:top;padding-bottom:0.01in;padding-right:0.01in;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;min-width:fit-content;">104</span></p></td>
    <td style="padding-top:0.01in;padding-left:0.01in;vertical-align:top;padding-bottom:0.01in;padding-right:0.01in;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;min-width:fit-content;"> </span></p></td>
    <td style="padding-top:0.01in;padding-left:0.01in;vertical-align:top;padding-bottom:0.01in;padding-right:0.01in;text-align:right;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:justify;"><span style="color:#000000;white-space:pre-wrap;min-width:fit-content;">Cover Page Interactive Data File (embedded within the Inline XBRL document)</span></p></td>
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8-K
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):
June 01, 2024
CORBUS PHARMACEUTICALS HOLDINGS, INC.
(Exact name of Registrant as Specified in Its Charter)
Delaware
001-37348
46-4348039
(State or Other Jurisdiction
of Incorporation)
(Commission File Number)
(IRS Employer
Identification No.)
500 River Ridge Drive
Norwood
,
Massachusetts
02062
(Address of Principal Executive Offices)
(Zip Code)
Registrant's Telephone Number, Including Area Code:
(617)
963-0100
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(s)
Name of each exchange on which registered
Common Stock, par value $0.0001 per share
CRBP
The Nasdaq Capital Market
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
☐
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.
☐
Item 7.01 Regulation FD Disclosure.
On June 1, 2024, Corbus Pharmaceuticals Holdings, Inc. (the "Company") issued a press release announcing data from the ongoing Phase 1 clinical trial for SYS6002 (CRB-701) conducted by the Company's development partner, CSPC Pharmaceutical Group, that was presented at the American Society of Clinical Oncology Annual Conference (the "ASCO Annual Conference") on June 1, 2024. A copy of the press release is attached hereto as Exhibit 99.1.
The Company also updated its presentation used by management to describe its business. A copy of the presentation is furnished as Exhibit 99.2 and is incorporated herein by reference.
The information in this Current Report on Form 8-K under Item 7.01, including the information contained in Exhibits 99.1 and 99.2, is being furnished to the Securities and Exchange Commission (the "SEC"), and shall not be deemed to be "filed" for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section, and shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by a specific reference in such filing.
Item 8.01 Other Events.
On June 1, 2024, the Company announced data from the ongoing Phase 1 clinical trial of SYS6002 (CRB-701) conducted by the Company's development partner, CSPC Pharmaceutical Group, that was presented at the ASCO Annual Conference on June 1, 2024.
The Phase 1 dose escalation study is being conducted in China and is enrolling patients with advanced solid tumors who have failed or were intolerant to standard treatment. Patients were enrolled based on Nectin-4 staining with the exception of metastatic urothelial cancer (mUC) patients who were considered to be Nectin-4 positive. The study opened for enrollment in January 2023 and the data presented is through April 2024 from 25 patients reflective of seven dose levels (0.2, 0.6, 1.2, 1.8, 2.7, 3.6 & 4.5 mg/Kg Q3W) and PK cohorts (2.7 and 3.6 mg/Kg).
Emerging clinical safety profile:
•
SYS6002 (CRB-701) was generally well tolerated with mainly grade 1 or 2 AEs.
•
No DLTs or grade 4 or 5 AEs have been observed to date.
•
Anemia and eye-related treatment emergent AEs (TEAEs) were the most common.
•
One patient exhibited a grade 3 rash which lasted for eight days and did not result in a reduction or interruption in dosing (2.7 mg/Kg). Two milder cases of skin rash were recorded (grade 1 and grade 2). Both also resolved with no need for change or interruption in dosing.
•
No new drug-related SAEs have been encountered since the January 2024 data update.
•
To date, a single case of peripheral neuropathy (grade 1) has been reported (numb hands) associated with hypokalemia (grade 3). It resolved in parallel with the hypokalemia after ten days of combined oral and/or parenteral K
+
replacement therapy.
•
Two grade 3 corneal disorders were reported in patients who received 2.7 mg/Kg and 3.6 mg/Kg, respectively. Preventative eye measures have been introduced and no such cases have been seen so far at the 4.5 mg/Kg dose. Over 50% of patients enrolled had corneal disorders or dry eye at baseline.
Emerging efficacy profile
•
Anti-tumor responses across multiple doses continue to be observed, with the ﬁrst conﬁrmed stable disease at 0.6 mg/Kg and the ﬁrst conﬁrmed partial response (PR), at 1.2 mg/Kg.
•
To date, SYS6002 (CRB-701) resulted in 44% overall response rate (ORR) and 78% disease control rate (DCR) in mUC (n=9, 4 PRs, 1 unconfirmed)  and 43% ORR and 86% DCR in cervical cancer (n=7, 3 PRs, 1 unconfirmed).
•
For all the tumor types combined at doses ≥ 2.7 mg/Kg, SYS6002 (CRB-701) resulted in 40% ORR and 73% DCR (n=15, 6 PRs, 2 unconfirmed). An additional PR was confirmed at the 1.2 mg/Kg for an mUC patient. Two unconfirmed PR's reported at ASCO-GU have since been confirmed.
Emerging clinical pharmacology
•
After a single IV infusion of SYS6002 (CRB-701), the exposure of ADC and MMAE generally increased in a dose proportional manner up to 2.7 mg/Kg.
•
Dosing beyond the 2.7 mg/Kg level showed a leveling off of free MMAE.
•
All dose levels studied to date are showing lower average levels of free MMAE than enfortumab vedotin at the reference dose (1.25 mg/Kg dosed on days 1, 8 and 15 of a 28-day cycle).
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit No.
Description
99.1
Press Release dated June 1, 2024
99.2
Investor Presentation
104
Cover Page Interactive Data File (embedded within the Inline XBRL document)
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.
Corbus Pharmaceuticals Holdings, Inc.
Date:
June 3, 2024
By:
/s/ Yuval Cohen
Name: Yuval Cohen
Title: Chief Executive Officer