Anti-αvβ8 monoclonal antibody programs (Venn Therapeutics)

Clinical update presented at ASCO 2024 for CRB-701 showed continued differentiated safety and encouraging efficacy in patients with metastatic urothelial cancer or cervical cancerCRB-701 Phase 1 dose escalation underway in USA and Europe for patients with metastatic urothelial cancer and other nectin-4 enriched tumors and is on schedule for completion in Q4 2024Cash runway extended through Q3 2027 with $147 million of cash & investments at June 30, 2024 NORWOOD, Mass., Aug. 06, 2024 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), today provided a corporate update and reported financial results for the quarter ended June 30, 2024. “We continue to make progress across our pipeline,” said Yuval Cohen, Ph.D., Chief Executive Officer of Corbus. “Updated clinical data was presented at ASCO 2024 by our development partner CSPC for CRB-701 (SYS6002). The data provided further evidence of the differentiated safety and encouraging efficacy first presented at ASCO GU in January 2024. This larger dataset of patients increases our confidence that CRB-701 is clinically active. The emerging safety data was reassuring showing low rates of skin rash and peripheral neuropathy and rare grade 3 adverse events. During the quarter, we commenced dose escalation in our corresponding U.S. and European Phase 1 clinical trial of CRB-701, a significant milestone that builds on this promising data. Separately, we expect to dose the first patient in Q1 2025 for CRB-913, our highly peripherally restricted oral CB1 inverse agonist. We look forward to continuing to advance our programs across our pipeline over the course of this year,” concluded Dr. Cohen. Key Corporate Updates CRB-701: Encouraging additional data from Phase 1 study presented at ASCO in June 2024: Results demonstrated 44% ORR and 78% DCR in metastatic urothelial cancer (“mUC”) and 43% ORR and 86% DCR in cervical cancer to date at doses ≥ 1.2mg/KgNo dose limiting toxicities (“DLTs”) have been observed to date in doses up to and including 4.5 mg/KgThree cases of skin rash (including one grade 3) and one case of grade 1 neuropathy seen to date; all were resolvedEarly pharmacokinetics (“PK”) data demonstrate consistently lower levels of free MMAE than enfortumab vedotin across all doses in the study, including 4.5 mg/Kg Dose escalation commenced in the Phase 1 clinical trial of CRB-701-01 in April 2024. The Phase 1 portion of the open label study design (NCT06265727), being conducted in the U.S. and Europe, will evaluate the safety, efficacy and PK of CRB-701 in participants with advanced solid tumors associated with high nectin-4 expression. The Phase 1 trial initiates with dose escalation followed by dose optimization and concludes with dose expansion to determine the recommended Phase 2 dose. The Company expects to complete the dose escalation phase in Q4 2024 and present the USA dose escalation data in Q1 2025. CRB-913: CRB-913 is a second-generation highly peripherally restricted CB1 receptor inverse agonist designed to treat obesity. In a diet-induced obesity ("DIO") mouse model, CRB-913, as a monotherapy and in combination with incretin analogs (tirzepatide, semaglutide, or liraglutide), demonstrated a reduction in body weight in DIO mice and improvements were observed in body fat content, leptinemia, insulin resistance, liver triglycerides, liver fat deposits, and liver histology.The Company expects to commence a Phase 1 study in the first quarter of 2025. CRB-601: CRB-601 is a high affinity and selective anti-αvβ8 monoclonal antibody that blocks the activation of TGFβ expressed on cancer cells in the tumor microenvironment. In pre-clinical models, CRB-601 demonstrates enhanced anti-tumor activity when combined with anti-PD-1 checkpoint inhibitor therapy compared to either single agent alone.In January 2024, the FDA cleared the IND for CRB-601, and the Company expects to initiate a Phase 1 study of CRB-601 in Q4 2024. Financial Results for Quarter Ended June 30, 2024: The Company reported a net loss of approximately $10.0 million, or a net loss per diluted share of $0.90 per share, for the three months ended June 30, 2024, compared to a net loss of approximately $8.8 million, or a net loss per diluted share of $2.05, for the same period in 2023. Operating expenses increased by $2.8 million to approximately $11.0 million for the three months ended June 30, 2024, compared to $8.2 million in the comparable period in the prior year. The increase was primarily attributable to an increase of $2.0 million in CRB-701 clinical trial costs with our contract research organization ("CRO") and clinical sites, as well as $0.3 million in drug manufacturing costs for CRB-913 offset by a $0.5 million decrease in toxicology costs as we transition from pre-clinical to clinical phase for CRB-601. The Company reported cash, cash equivalents and investments of $147 million at June 30, 2024. During the second quarter, the Company raised $35.6 million of net proceeds pursuant to the Company’s ATM program and subsequent to quarter end through August 1, 2024, the Company raised approximately an additional $28.8 million of net proceeds pursuant to the ATM program. The $147 million of cash, cash equivalents and investments at June 30, 2024 together with the $28.8 million of additional net proceeds raised through August 1, 2024 is expected to fund operations through Q3 2027, based on planned expenditures. About CorbusCorbus Pharmaceuticals Holdings, Inc. is a precision oncology company with a diversified portfolio and is committed to helping people defeat serious illness by bringing innovative scientific approaches to well understood biological pathways. Corbus’ pipeline includes CRB-701, a next-generation antibody drug conjugate that targets the expression of nectin-4 on cancer cells to release a cytotoxic payload, CRB-601, an anti-integrin monoclonal antibody which blocks the activation of TGFβ expressed on cancer cells, and CRB-913, a highly peripherally restricted CB1 inverse agonist for the treatment of obesity. Corbus is headquartered in Norwood, Massachusetts. For more information on Corbus, visit corbuspharma.com. Connect with us on Twitter, LinkedIn and Facebook. Forward-Looking Statements This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company’s trial results, product development, clinical and regulatory timelines, including timing for completion of trials and presentation of data, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management’s current beliefs and assumptions. These statements may be identified by the use of forward-looking expressions, including, but not limited to, “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate,” “potential,” “predict,” “project,” “should,” “would” and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors on our operations, clinical development plans and timelines, which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company’s filings with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. All product names, logos, brands and company names are trademarks or registered trademarks of their respective owners. Their use does not imply affiliation or endorsement by these companies. INVESTOR CONTACT: Sean MoranChief Financial OfficerCorbus Pharmaceuticalssmoran@corbuspharma.com Bruce MackleManaging DirectorLifeSci Advisors, LLCbmackle@lifesciadvisors.com ---tables to follow--- Corbus Pharmaceuticals Holdings, Inc.Condensed Consolidated Statements of Operations and Comprehensive Loss(in thousands, except share and per share amounts)(Unaudited) For the Three MonthsEnded June 30, For the Six MonthsEnded June 30, 2024 2023 2024 2023 Operating expenses: Research and development $6,865 $4,249 $12,627 $17,637 General and administrative 4,123 3,940 7,984 7,849 Total operating expenses 10,988 8,189 20,611 25,486 Operating loss (10,988) (8,189) (20,611) (25,486)Other income (expense), net: Other income, net 695 183 3,604 412 Interest income 906 232 1,568 494 Interest expense (652) (1,008) (1,491) (1,948)Change in fair value of derivative liability 11 — 39 — Foreign currency transaction (loss) gain, net 31 (2) (5) (1)Other income (expense), net 991 (595) 3,715 (1,043)Net loss $(9,997) $(8,784) $(16,896) $(26,529)Net loss per share, basic and diluted $(0.90) $(2.05) $(1.75) $(6.27)Weighted average number of common shares outstanding, basic and diluted 11,053,241 4,277,701 9,681,875 4,229,894 Comprehensive loss: Net loss $(9,997) $(8,784) $(16,896) $(26,529)Other comprehensive (loss) income: Change in unrealized (loss) gain on marketable debt securities (59) 45 (387) 103 Total other comprehensive (loss) income (59) 45 (387) 103 Total comprehensive loss $(10,056) $(8,739) $(17,283) $(26,426) Corbus Pharmaceuticals Holdings, Inc.Condensed Consolidated Balance Sheets(in thousands, except share and per share amounts) June 30, 2024(Unaudited) December 31, 2023 ASSETS Current assets: Cash and cash equivalents $23,686 $13,724 Investments 123,339 7,182 Restricted cash 285 192 Prepaid expenses and other current assets 1,001 2,448 Total current assets 148,311 23,546 Restricted cash 385 478 Property and equipment, net 671 973 Operating lease right-of-use assets 2,612 3,063 Other assets — 212 Total assets $151,979 $28,272 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities: Notes payable $77 $301 Accounts payable 1,152 3,179 Accrued expenses 10,488 11,030 Derivative liability — 39 Operating lease liabilities, current 1,519 1,437 Loan payable 10,744 15,908 Total current liabilities 23,980 31,894 Other long-term liabilities — 44 Operating lease liabilities, noncurrent 2,456 3,239 Total liabilities 26,436 35,177 Stockholders’ equity Preferred stock, $0.0001 par value; 10,000,000 shares authorized, no shares issued and outstanding at June 30, 2024 and December 31, 2023. — — Common stock, $0.0001 par value; 300,000,000 shares authorized,11,498,917 and 4,423,683 shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively 1 — Additional paid-in capital 579,510 429,780 Accumulated deficit (453,580) (436,684)Accumulated other comprehensive loss (388) (1)Total stockholders’ equity (deficit) 125,543 (6,905)Total liabilities and stockholders’ equity $151,979 $28,272

Phase 1 data for CRB-701 (SYS6002) to be presented at ASCO Annual Meeting on June 1, 2024 $116M of capital raised in Q1 2024 extending cash runway through Q1 2027 Appointed Dr. Dominic Smethurst as Chief Medical Officer NORWOOD, Mass., May 07, 2024 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), a precision oncology company with a diversified portfolio, today provided a corporate update and reported financial results for the quarter ended March 31, 2024. “During the first quarter of 2024, we continued to make significant progress in advancing our pipeline toward meaningful milestones led by the dosing of the first patient in our U.S. Phase 1 clinical trial of CRB-701, our next-generation antibody drug conjugate targeting expression of Nectin-4,” said Yuval Cohen, Ph.D., Chief Executive Officer of Corbus. “The potential of CRB-701 was highlighted at ASCO GU in January 2024. The dose escalation data, presented by our development partner CSPC, demonstrated a differentiated safety and PK profile compared to enfortumab vedotin, as well as an emerging efficacy signal in both bladder and cervical cancer patients who are Nectin-4 positive. We look forward to CSPC’s presentation of updated data at the ASCO 2024 Annual Meeting. During the quarter, we also continued to advance CRB-913 for the treatment of obesity and expect to dose the first patient in Q1 2025. We strengthened our balance sheet by raising $116 million of capital in the quarter and bolstered our management team with the appointment of Dr. Dominic Smethurst as Chief Medical Officer. We look forward to continuing to advance our programs across our pipeline over the course of this year,” concluded Dr. Cohen. Key Corporate and Program Updates: CRB-701:CRB-701 (SYS6002) is a next-generation antibody drug conjugate targeting Nectin-4 that contains a site-specific, cleavable linker and a homogenous drug antibody ratio of 2 using MMAE as the payload. Nectin-4 is a clinically validated, tumor-associated antigen in urothelial cancer. The first U.S. patient was dosed in the Phase 1 clinical trial of CRB-701-01 in April 2024. The Phase 1 portion of the open label study design (NCT06265727), being conducted in the U.S. and Europe, will evaluate the safety, efficacy and pharmacokinetics (“PK”) of CRB-701 in participants with advanced solid tumors associated with high Nectin-4 expression. The Phase 1 trial initiates with dose escalation followed by dose optimization and concludes with dose expansion to determine the recommended Phase 2 dose. The Company expects to present the U.S. dose escalation data by Q1 2025. Encouraging safety and efficacy data from the Phase 1 dose escalation study in China for patients with Nectin-4 positive tumors was presented in January 2024 by our development partner CSPC at the 2024 American Society of Clinical Oncology Genitourinary Cancers Symposium (“ASCO GU”) as a Poster Presentation. Summary of data presented at ASCO GU: Q3W schedule of CRB-701 (SYS6002) demonstrated a 43% ORR and 71% DCR (n=7) at predicted therapeutically relevant doses (>=2.7mgs/kg).All assessable Nectin-4 positive study participants with mUC or cervical cancer treated at or above this dose demonstrated some level of disease control.No dose limiting toxicities were observed to date at doses up to 3.6 mg/kg with further escalation at 4.5 mg/kg ongoing.No cases of peripheral neuropathy or skin rash have been observed to date. Updated data from this study will be presented by CSPC as a poster at the ASCO 2024 Annual Meeting on June 1, 2024. CRB-913: CRB-913 is a second-generation, highly peripherally restricted CB1 receptor inverse agonist designed to treat obesity. In a diet-induced obesity ("DIO") mouse model, CRB-913, as a monotherapy and in combination with incretin analogues (tirzepatide, semaglutide, or liraglutide), demonstrates a reduction in body weight in DIO mice and improvements were observed in body fat content, leptinemia, insulin resistance, liver triglycerides, liver fat deposits, and liver histology. The Company is currently conducting IND-enabling studies and expects to dose the first patient in the Phase 1 study in Q1 2025. CRB-601: CRB-601 is a high affinity and selective anti-αvβ8 monoclonal antibody that blocks the activation of TGFβ expressed on cancer cells in the tumor microenvironment. In pre-clinical models, CRB-601 demonstrates enhanced anti-tumor activity when combined with anti-PD-1 checkpoint inhibitor therapy compared to either single agent alone. In January 2024, the FDA cleared the IND for CRB-601 and the Company expects to initiate a Phase 1 study of CRB-601 in the summer of 2024. $116M of Capital Raised in Q1 2024Immediately following the ASCO GU data, the Company completed a public offering raising $94.5 million of gross proceeds combined with an additional $21.1 million from ATM sales. The $116 million of additional capital extends the Company’s cash runway through Q1 2027. Dr. Dominic Smethurst Appointed as Chief Medical Officer In February 2024, the Company appointed Dr. Dominic Smethurst, MA MRCP, as the Company’s Chief Medical Officer (“CMO”). He has over twenty years of experience working with pharmaceutical and biotechnology companies and most recently served as the CMO of Bicycle Therapeutics. Financial Results for Quarter Ended March 31, 2024:The Company reported a net loss of approximately $6.9 million, or a net loss per diluted share of $0.83, for the three months ended March 31, 2024, compared to a net loss of approximately $17.7 million, or a net loss per diluted share of $4.24, for the same period in 2023. Operating expenses decreased by $7.7 million to approximately $9.6 million for the three months ended March 31, 2024, compared to $17.3 million in the comparable period in the prior year. The decrease was primarily attributable to the upfront licensing fee of $7.5 million due to CSPC for licensing of CRB-701 recorded during the first quarter of 2023. In Q1 2024, the Company received $2.5 million refundable tax credit from a foreign tax authority that was recorded in Other Income, net. As of March 31, 2024, the Company had $120.1 million of cash, cash equivalents and investments on hand, which is expected to fund operations through Q1 2027, based on the current planned expenditures. About CorbusCorbus Pharmaceuticals Holdings, Inc. is a precision oncology company with a diversified portfolio and is committed to helping people defeat serious illness by bringing innovative scientific approaches to well-understood biological pathways. Corbus’ pipeline includes CRB-701, a next generation antibody drug conjugate that targets the expression of Nectin-4 on cancer cells to release a cytotoxic payload, CRB-601, an anti-integrin monoclonal antibody which blocks the activation of TGFβ expressed on cancer cells, and CRB-913, a highly peripherally restricted CB1 receptor inverse agonist for the treatment of obesity. Corbus is headquartered in Norwood, Massachusetts. For more information on Corbus, visit corbuspharma.com. Connect with us on Twitter, LinkedIn and Facebook. Forward-Looking StatementsThis press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company's trial results, product development, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statement that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management's current beliefs and assumptions. These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential,” "predict," "project," "should," "would" and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors on our operations, clinical development plans and timelines, which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company's filings with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. All product names, logos, brands and company names are trademarks or registered trademarks of their respective owners. Their use does not imply affiliation or endorsement by these companies. INVESTOR CONTACTS: Sean MoranChief Financial Officersmoran@corbuspharma.com Bruce MackleManaging DirectorLifeSci Advisors, LLCbmackle@lifesciadvisors.com ---tables to follow--- Corbus Pharmaceuticals Holdings, Inc.Condensed Consolidated Statements of Operations and Comprehensive Loss For the Three MonthsEnded March 31, 2024 2023 Operating expenses: Research and development $5,761,494 $13,388,343 General and administrative 3,861,251 3,908,682 Total operating expenses 9,622,745 17,297,025 Operating loss (9,622,745) (17,297,025) Other income (expense), net: Other income, net 2,909,097 229,507 Interest expense, net (177,015) (678,022) Change in fair value of derivative liability 28,568 — Foreign currency transaction (loss) gain, net (36,676) 728 Other income (expense), net 2,723,974 (447,787) Net loss $(6,898,771) $(17,744,812) Net loss per share, basic and diluted $(0.83) $(4.24) Weighted average number of common shares outstanding, basic and diluted 8,310,508 4,181,556 Comprehensive loss: Net loss $(6,898,771) $(17,744,812) Other comprehensive (loss) income : Change in unrealized (loss) gain on marketable debt securities (326,949) 57,623 Total other comprehensive (loss) income (326,949) 57,623 Total comprehensive loss $(7,225,720) $(17,687,189) Corbus Pharmaceuticals Holdings, Inc.Consolidated Balance Sheets March 31, 2024(Unaudited) December 31, 2023 ASSETS Current assets: Cash and cash equivalents $14,103,120 $13,723,681 Investments 106,000,091 7,182,325 Restricted cash 284,950 192,475 Prepaid expenses and other current assets 1,308,336 2,447,549 Total current assets 121,696,497 23,546,030 Restricted cash 384,950 477,425 Property and equipment, net 821,526 973,214 Operating lease right-of-use assets 2,841,189 3,062,920 Other assets — 212,804 Total assets $125,744,162 $28,272,393 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities: Notes payable $189,818 $300,664 Accounts payable 2,081,812 3,178,516 Accrued expenses 9,398,225 11,030,506 Derivative liability 10,882 39,450 Operating lease liabilities, current 1,477,669 1,436,723 Current portion of long-term debt 12,764,915 15,908,214 Total current liabilities 25,923,321 31,894,073 Other long-term liabilities — 44,411 Operating lease liabilities, noncurrent 2,855,140 3,238,631 Total liabilities 28,778,461 35,177,115 Stockholders’ equity Preferred stock, $0.0001 par value; 10,000,000 shares authorized, no shares issued and outstanding at March 31, 2024 and December 31, 2023 — — Common stock, $0.0001 par value; 300,000,000 shares authorized,10,507,237 and 4,423,683 shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively 1,050 442 Additional paid-in capital 540,875,910 429,780,375 Accumulated deficit (443,582,754) (436,683,983)Accumulated other comprehensive loss (328,505) (1,556)Total stockholders’ equity (deficit) 96,965,701 (6,904,722) Total liabilities and stockholders’ equity $125,744,162 $28,272,393