Press Releases Events & Presentations Press Release Assembly Biosciences Reports Second Quarter 2019 Financial Results and Recent Highlights August 5, 2019 at 4:05 PM EDT PDF Version SOUTH SAN FRANCISCO, Calif., Aug. 05, 2019 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (NASDAQ: ASMB), a clinical-stage biotechnology company developing innovative therapeutics targeting hepatitis B virus (HBV) and diseases associated with the microbiome, today reported financial results and recent highlights for the second quarter ended June 30, 2019. “The second quarter of 2019 has been a period of great progress as we continue our transition into later stage clinical development. Following a series of data presentations at EASL in Vienna and IASL in China, we have continued to progress our HBV clinical candidates, now on a global scale,” said Derek Small, President and Chief Executive Officer. “We are also excited that the first oral microbiome biologic drug candidate from our proprietary platform is being evaluated in patients, with our Phase 1b clinical trial of ABI-M201 for mildly to moderately active ulcerative colitis underway.” Second Quarter 2019 and Recent Highlights Oral presentation, “New Therapies to More Effectively Eliminate Viral Replication and Increase Cure Rates in CHB Patients,” at the first International Association for the Study of the Liver (IASL) Congress on June 22, 2019 in Beijing, China by Richard Colonno, EVP and CSO of Virology Operations. • Reviewed science and strategies for utilizing HBV core inhibitors as well as interim clinical data previously reported by the company in April 2019 at The International Liver Congress™(ILC), the Annual Meeting of the European Association for the Study of the Liver (EASL). Received Clinical Trial Application (CTA) approvals from China’s Center for Drug Evaluation (CDE), part of the National Medical Products Administration (NMPA) in China, enabling Assembly’s plans to initiate Phase 2 and Phase 1 clinical trials of both 731 and 2158, respectively, at leading HBV trial sites in China. Dosed first patient with ABI-H2158 in Phase 1b dose escalation study in HBV patients. Dosed first patient with ABI-M201 in a Phase 1b clinical trial for mildly to moderately active ulcerative colitis (UC). • First oral microbiome biologic drug candidate from Assembly’s proprietary microbiome platform to enter clinical trials in patients. Steve Knox, SVP, Clinical Development and David Houck, PhD, SVP Product Development & Portfolio Management joined Assembly’s leadership team as the company transitions to a later stage development organization. Anticipated Milestones and Events HBV Program ABI-H0731 • Additional data from the ongoing long-term Phase 2a trial combining 731 with Nuc therapy, including 48-week interim results, expected in Q4 2019. ABI-H2158 • Data from Phase 1b trial in HBV-infected subjects expected in Q1 2020. ABI-H3733 • Phase 1a trial expected to initiate in Q1 2020. Microbiome Program ABI-M201 • Enrollment and dosing ongoing in Phase 1b trial in patients with mildly to moderately active UC. Microbiome Platform • Leveraging discovery and development capabilities and manufacturing expertise to advance new proprietary candidates for other disease indications. Upcoming Conferences Baird’s 2019 Global Healthcare Conference, in New York on September 5, 2019 at 10:15am ET Second Quarter 2019 Financial Results Cash, cash equivalents and marketable securities were approximately $173.8 million as of June 30, 2019, compared to approximately $193.5 million as of March 31, 2019. This quarter-end cash position is projected to fund operations into 2021. Revenues from collaborative research were approximately $3.1 million for the three months ended June 30, 2019 compared to $3.2 million for the same period in 2018. Research and development expenses, excluding stock-based compensation expense, were approximately $15.6 million for the three months ended June 30, 2019, compared to approximately $14.2 million for the same period in 2018. Stock-based compensation expense was approximately $3.1 million for the three months ended June 30, 2019, compared to approximately $3.7 million for the same period in 2018. General and administrative expenses, excluding stock-based compensation expense, were approximately $5.1 million for the three months ended June 30, 2019, compared to $4.6 million for the same period in 2018. Stock-based compensation expense was approximately $(1.1) million for the three months ended June 30, 2019, compared to approximately $7.9 million for the same period in 2018. This decrease was primarily due to the reversal of previously recognized expense of $3.6 million related to forfeited awards to a former officer who departed during the most recent period coupled with a $4.3 million one-time expense related to the departure and transition to consultant of a former officer in 2018. Net loss attributable to common stockholders was approximately $18.5 million, or $0.72 per basic and diluted share, for the three months ended June 30, 2019, compared to approximately $26.8 million, or $1.30 per basic and diluted share, for the same period in 2018. About Assembly BiosciencesAssembly Biosciences, Inc. is a clinical-stage biotechnology company developing innovative therapeutics targeting hepatitis B virus (HBV) and diseases associated with the microbiome. The HBV program is focused on advancing a new class of potent, oral core inhibitors that have the potential to increase cure rates for chronically infected patients. The microbiome program is developing novel oral live microbial biotherapeutic candidates with Assembly’s fully integrated platform, including a robust process for strain identification and selection, GMP banking and production, and targeted delivery to the lower gastrointestinal tract with the GEMICEL® technology. For more information, visit assemblybio.com. Forward-Looking Statements The information in this press release contains forward-looking statements regarding future events, including statements about the clinical and therapeutic potential of core inhibitors, the timing of the initiation of and the availability of data from our ongoing and planned clinical trials and cash projections. Certain forward-looking statements may be identified by reference to a future period or by use of forward-looking terminology such as “expected,” “plans,” “potential” and “projected.” Assembly intends such forward-looking statements to be covered by the safe harbor provisions contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. These risks and uncertainties include, among others: the components, timing, cost and results of clinical trials and other development activities involving our product candidates (including those licensed by Allergan Pharmaceuticals International Limited); the unpredictability of the preclinical and clinical development of our product candidates and of the duration and results of regulatory review of those candidates by the FDA and foreign regulatory authorities; our anticipated capital expenditures and our estimates regarding our capital requirements; and the possible impairment of, or inability to obtain, intellectual property rights and the costs of obtaining such rights from third parties. More information about the risks and uncertainties faced by Assembly are more fully detailed under the heading “Risk Factors” in Assembly's Quarterly Report on Form 10-Q for the quarter ended June 30, 2019 filed with the Securities and Exchange Commission. Except as required by law, Assembly assumes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. ContactsAssembly Biosciences, Inc. Investors:Lauren Glaser (415) 521-3828lglaser@assemblybio.com ASSEMBLY BIOSCIENCES, INC. CONDENSED CONSOLIDATED BALANCE SHEETS ($ in thousands except for share and per share amounts) June 30, December 31, 2019 2018 (Unaudited) ASSETS Current assets Cash and cash equivalents $ 34,258 $ 41,471 Marketable securities 139,553 176,609 Accounts receivable from collaboration 2,903 2,430 Prepaid expenses and other current assets 6,746 1,992 Total current assets 183,460 222,502 Property and equipment, net 2,048 557 Operating lease right-of-use assets 12,672 - Other assets 1,693 3,348 Indefinite-lived intangible asset 29,000 29,000 Goodwill 12,638 12,638 Total assets $ 241,511 $ 268,045 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities Accounts payable $ 3,414 $ 3,693 Accrued expenses 7,585 9,679 Deferred revenue - short-term 6,082 5,100 Operating lease liabilities - short-term 2,854 - Total current liabilities 19,935 18,472 Deferred rent - 108 Deferred tax liabilities 3,252 3,252 Deferred revenue - long-term 33,582 35,560 Operating lease liabilities - long-term 10,035 - Total liabilities 66,804 57,392 Commitments and contingencies Stockholders' equity Preferred stock, $0.001 par value; 5,000,000 shares authorized; no shares issued or outstanding - - Common stock, $0.001 par value; 100,000,000 shares authorized as of June 30, 2019 and December 31, 2018; 25,646,783 and 25,495,425 shares issued and outstanding as of June 30, 2019 and December 31, 2018, respectively 26 25 Additional paid-in capital 562,210 552,762 Accumulated other comprehensive loss (187 ) (347 ) Accumulated deficit (387,342 ) (341,787 ) Total stockholders' equity 174,707 210,653 Total liabilities and stockholders' equity $ 241,511 $ 268,045 ASSEMBLY BIOSCIENCES, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS ($ in thousands except for share and per share amounts) (Unaudited) Three Months Ended June 30, Six Months Ended June 30, 2019 2018 2019 2018 Collaboration revenue $ 3,080 $ 3,218 $ 6,966 $ 6,783 Operating expenses: Research and development 18,700 17,840 41,405 32,381 General and administrative 4,080 12,544 13,597 18,240 Total operating expenses 22,780 30,384 55,002 50,621 Loss from operations (19,700 ) (27,166 ) (48,036 ) (43,838 ) Other income (expenses) Interest and other income 1,182 453 2,458 899 Other income (expense), net 4 (127 ) 5 (150 ) Total other income 1,186 326 2,463 749 Loss before income taxes (18,514 ) (26,840 ) (45,573 ) (43,089 ) Income tax benefit 11 34 18 34 Net loss $ (18,503 ) $ (26,806 ) $ (45,555 ) $ (43,055 ) Other comprehensive (loss) income Unrealized gain on marketable securities, net of tax 52 87 160 20 Comprehensive loss $ (18,451 ) $ (26,719 ) $ (45,395 ) $ (43,035 ) Net loss per share, basic and diluted $ (0.72 ) $ (1.30 ) $ (1.77 ) $ (2.11 ) Weighted average common shares outstanding, basic and diluted 25,740,500 20,541,549 25,690,617 20,387,532 Source: Assembly Biosciences, Inc. 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Assembly Biosciences Reports Second Quarter 2019 Financial Results and Recent Highlights August 5, 2019 at 4:05 PM EDT PDF Version SOUTH SAN FRANCISCO, Calif., Aug. 05, 2019 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (NASDAQ: ASMB), a clinical-stage biotechnology company developing innovative therapeutics targeting hepatitis B virus (HBV) and diseases associated with the microbiome, today reported financial results and recent highlights for the second quarter ended June 30, 2019. “The second quarter of 2019 has been a period of great progress as we continue our transition into later stage clinical development. Following a series of data presentations at EASL in Vienna and IASL in China, we have continued to progress our HBV clinical candidates, now on a global scale,” said Derek Small, President and Chief Executive Officer. “We are also excited that the first oral microbiome biologic drug candidate from our proprietary platform is being evaluated in patients, with our Phase 1b clinical trial of ABI-M201 for mildly to moderately active ulcerative colitis underway.” Second Quarter 2019 and Recent Highlights Oral presentation, “New Therapies to More Effectively Eliminate Viral Replication and Increase Cure Rates in CHB Patients,” at the first International Association for the Study of the Liver (IASL) Congress on June 22, 2019 in Beijing, China by Richard Colonno, EVP and CSO of Virology Operations. • Reviewed science and strategies for utilizing HBV core inhibitors as well as interim clinical data previously reported by the company in April 2019 at The International Liver Congress™(ILC), the Annual Meeting of the European Association for the Study of the Liver (EASL). Received Clinical Trial Application (CTA) approvals from China’s Center for Drug Evaluation (CDE), part of the National Medical Products Administration (NMPA) in China, enabling Assembly’s plans to initiate Phase 2 and Phase 1 clinical trials of both 731 and 2158, respectively, at leading HBV trial sites in China. Dosed first patient with ABI-H2158 in Phase 1b dose escalation study in HBV patients. Dosed first patient with ABI-M201 in a Phase 1b clinical trial for mildly to moderately active ulcerative colitis (UC). • First oral microbiome biologic drug candidate from Assembly’s proprietary microbiome platform to enter clinical trials in patients. Steve Knox, SVP, Clinical Development and David Houck, PhD, SVP Product Development & Portfolio Management joined Assembly’s leadership team as the company transitions to a later stage development organization. Anticipated Milestones and Events HBV Program ABI-H0731 • Additional data from the ongoing long-term Phase 2a trial combining 731 with Nuc therapy, including 48-week interim results, expected in Q4 2019. ABI-H2158 • Data from Phase 1b trial in HBV-infected subjects expected in Q1 2020. ABI-H3733 • Phase 1a trial expected to initiate in Q1 2020. Microbiome Program ABI-M201 • Enrollment and dosing ongoing in Phase 1b trial in patients with mildly to moderately active UC. Microbiome Platform • Leveraging discovery and development capabilities and manufacturing expertise to advance new proprietary candidates for other disease indications. Upcoming Conferences Baird’s 2019 Global Healthcare Conference, in New York on September 5, 2019 at 10:15am ET Second Quarter 2019 Financial Results Cash, cash equivalents and marketable securities were approximately $173.8 million as of June 30, 2019, compared to approximately $193.5 million as of March 31, 2019. This quarter-end cash position is projected to fund operations into 2021. Revenues from collaborative research were approximately $3.1 million for the three months ended June 30, 2019 compared to $3.2 million for the same period in 2018. Research and development expenses, excluding stock-based compensation expense, were approximately $15.6 million for the three months ended June 30, 2019, compared to approximately $14.2 million for the same period in 2018. Stock-based compensation expense was approximately $3.1 million for the three months ended June 30, 2019, compared to approximately $3.7 million for the same period in 2018. General and administrative expenses, excluding stock-based compensation expense, were approximately $5.1 million for the three months ended June 30, 2019, compared to $4.6 million for the same period in 2018. Stock-based compensation expense was approximately $(1.1) million for the three months ended June 30, 2019, compared to approximately $7.9 million for the same period in 2018. This decrease was primarily due to the reversal of previously recognized expense of $3.6 million related to forfeited awards to a former officer who departed during the most recent period coupled with a $4.3 million one-time expense related to the departure and transition to consultant of a former officer in 2018. Net loss attributable to common stockholders was approximately $18.5 million, or $0.72 per basic and diluted share, for the three months ended June 30, 2019, compared to approximately $26.8 million, or $1.30 per basic and diluted share, for the same period in 2018. About Assembly BiosciencesAssembly Biosciences, Inc. is a clinical-stage biotechnology company developing innovative therapeutics targeting hepatitis B virus (HBV) and diseases associated with the microbiome. The HBV program is focused on advancing a new class of potent, oral core inhibitors that have the potential to increase cure rates for chronically infected patients. The microbiome program is developing novel oral live microbial biotherapeutic candidates with Assembly’s fully integrated platform, including a robust process for strain identification and selection, GMP banking and production, and targeted delivery to the lower gastrointestinal tract with the GEMICEL® technology. For more information, visit assemblybio.com. Forward-Looking Statements The information in this press release contains forward-looking statements regarding future events, including statements about the clinical and therapeutic potential of core inhibitors, the timing of the initiation of and the availability of data from our ongoing and planned clinical trials and cash projections. Certain forward-looking statements may be identified by reference to a future period or by use of forward-looking terminology such as “expected,” “plans,” “potential” and “projected.” Assembly intends such forward-looking statements to be covered by the safe harbor provisions contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. These risks and uncertainties include, among others: the components, timing, cost and results of clinical trials and other development activities involving our product candidates (including those licensed by Allergan Pharmaceuticals International Limited); the unpredictability of the preclinical and clinical development of our product candidates and of the duration and results of regulatory review of those candidates by the FDA and foreign regulatory authorities; our anticipated capital expenditures and our estimates regarding our capital requirements; and the possible impairment of, or inability to obtain, intellectual property rights and the costs of obtaining such rights from third parties. More information about the risks and uncertainties faced by Assembly are more fully detailed under the heading “Risk Factors” in Assembly's Quarterly Report on Form 10-Q for the quarter ended June 30, 2019 filed with the Securities and Exchange Commission. Except as required by law, Assembly assumes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. ContactsAssembly Biosciences, Inc. Investors:Lauren Glaser (415) 521-3828lglaser@assemblybio.com ASSEMBLY BIOSCIENCES, INC. CONDENSED CONSOLIDATED BALANCE SHEETS ($ in thousands except for share and per share amounts) June 30, December 31, 2019 2018 (Unaudited) ASSETS Current assets Cash and cash equivalents $ 34,258 $ 41,471 Marketable securities 139,553 176,609 Accounts receivable from collaboration 2,903 2,430 Prepaid expenses and other current assets 6,746 1,992 Total current assets 183,460 222,502 Property and equipment, net 2,048 557 Operating lease right-of-use assets 12,672 - Other assets 1,693 3,348 Indefinite-lived intangible asset 29,000 29,000 Goodwill 12,638 12,638 Total assets $ 241,511 $ 268,045 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities Accounts payable $ 3,414 $ 3,693 Accrued expenses 7,585 9,679 Deferred revenue - short-term 6,082 5,100 Operating lease liabilities - short-term 2,854 - Total current liabilities 19,935 18,472 Deferred rent - 108 Deferred tax liabilities 3,252 3,252 Deferred revenue - long-term 33,582 35,560 Operating lease liabilities - long-term 10,035 - Total liabilities 66,804 57,392 Commitments and contingencies Stockholders' equity Preferred stock, $0.001 par value; 5,000,000 shares authorized; no shares issued or outstanding - - Common stock, $0.001 par value; 100,000,000 shares authorized as of June 30, 2019 and December 31, 2018; 25,646,783 and 25,495,425 shares issued and outstanding as of June 30, 2019 and December 31, 2018, respectively 26 25 Additional paid-in capital 562,210 552,762 Accumulated other comprehensive loss (187 ) (347 ) Accumulated deficit (387,342 ) (341,787 ) Total stockholders' equity 174,707 210,653 Total liabilities and stockholders' equity $ 241,511 $ 268,045 ASSEMBLY BIOSCIENCES, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS ($ in thousands except for share and per share amounts) (Unaudited) Three Months Ended June 30, Six Months Ended June 30, 2019 2018 2019 2018 Collaboration revenue $ 3,080 $ 3,218 $ 6,966 $ 6,783 Operating expenses: Research and development 18,700 17,840 41,405 32,381 General and administrative 4,080 12,544 13,597 18,240 Total operating expenses 22,780 30,384 55,002 50,621 Loss from operations (19,700 ) (27,166 ) (48,036 ) (43,838 ) Other income (expenses) Interest and other income 1,182 453 2,458 899 Other income (expense), net 4 (127 ) 5 (150 ) Total other income 1,186 326 2,463 749 Loss before income taxes (18,514 ) (26,840 ) (45,573 ) (43,089 ) Income tax benefit 11 34 18 34 Net loss $ (18,503 ) $ (26,806 ) $ (45,555 ) $ (43,055 ) Other comprehensive (loss) income Unrealized gain on marketable securities, net of tax 52 87 160 20 Comprehensive loss $ (18,451 ) $ (26,719 ) $ (45,395 ) $ (43,035 ) Net loss per share, basic and diluted $ (0.72 ) $ (1.30 ) $ (1.77 ) $ (2.11 ) Weighted average common shares outstanding, basic and diluted 25,740,500 20,541,549 25,690,617 20,387,532 Source: Assembly Biosciences, Inc.
