Cartesian Therapeutics(RNAC)
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Selecta Biosciences (SELB) Investor Presentation - Slideshow
2020-08-10 16:37
O श्रे Selecta. Biosciences Corporate Presentation August 2020 SELB Nasdaq Safe harbor/disclaimer Any statements in this presentation about the future expectations, plans and prospects of Selecta Biosciences, Inc. ("the company"), including without limitation, statements regarding the progress of the clinical development of SEL-212, the anticipated timing of the head-to-head trial comparing SEL-212 and pegloticase and related data readouts, the potential of ImmTOR™ to reduce AAV vector immunogenicity and en ...
Cartesian Therapeutics(RNAC) - 2020 Q2 - Earnings Call Transcript
2020-08-09 17:27
Financial Data and Key Metrics Changes - As of June 30, 2020, the company had $61.4 million in cash, cash equivalents, and restricted cash, down from $91.6 million as of December 31, 2019 [24] - Net cash used in operating activities was $23.5 million for the first half of 2020, compared to $27.4 million for the same period in 2019 [25] - The company reported a net loss of $24.1 million or $0.25 per share for the second quarter of 2020, compared to a net loss of $16.4 million or $0.37 per share for the same period in 2019 [26] Business Line Data and Key Metrics Changes - Research and development expenses for Q2 2020 were $10.7 million, down from $12.1 million in Q2 2019, primarily due to reduced expenses for the Phase II COMPARE trial for SEL-212 [25] - General and administrative expenses increased to $5.6 million in Q2 2020 from $4.1 million in Q2 2019, attributed to higher salaries and legal fees [26] Market Data and Key Metrics Changes - The strategic licensing agreement with Sobi, which closed on July 28, 2020, allows Sobi to assume responsibility for all development, regulatory, and commercial activities in all markets except China [9][11] - The company anticipates the initiation of the Phase III clinical program for SEL-212 in Q3 2020, consisting of two double-blinded placebo-controlled trials [12] Company Strategy and Development Direction - The company aims to maximize the potential of the ImmTOR immune tolerance platform, focusing on optimizing the efficacy and safety of biologics and enabling redosing of gene therapies [9][10] - The company has entered into a research license agreement with Sarepta for the use of ImmTOR in neuromuscular diseases, particularly Duchenne muscular dystrophy [15] - The lead gene therapy program in methylmalonic acidemia (MMA) is expected to enter the clinic in the first half of 2021, with preliminary data anticipated in the second half of 2021 [16] Management's Comments on Operating Environment and Future Outlook - Management described Q2 2020 as a transformational time for the company, emphasizing the importance of strategic business decisions made during this period [8] - The management expressed confidence in the company's ability to advance its clinical programs and capitalize on business development opportunities [27] Other Important Information - The company plans to host an R&D Day in October to provide specific details on gene therapy and autoimmune disease programs [27] - The newly appointed Chief Medical Officer, Dr. Peter G. Traber, brings extensive experience and will oversee medical affairs and clinical development [19] Q&A Session Summary Question: What are the gating factors before entering the clinic for MMA? - The company is finalizing toxicology studies and preparing for the IND filing, on track to start the trial in the first half of next year [30] Question: How will the dosing schedule be determined for the OTC deficiency program? - The company will use learnings from the MMA program for dose finding and aims to prevent the formation of neutralizing antibodies as a proof of concept [34][36] Question: What specific antigens are being targeted for IgA nephropathy? - The approach will involve combining ImmTOR with an IgA protease to address IgA immune complex deposits in the kidney [39] Question: How does the ImmTOR platform translate across different serotypes? - The technology is believed to be agnostic to serotypes, with applications for next-generation capsids [44] Question: What are the economic terms of the AskBio partnership? - The partnership includes a classical licensing deal with upfront payments and milestone payments, as well as a 50-50 cost and profit-sharing collaboration for the MMA program [67]
Cartesian Therapeutics(RNAC) - 2020 Q2 - Quarterly Report
2020-08-06 20:16
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 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, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 001-37798 Selecta Biosciences, Inc. (Exact name of registrant as specified in its charter) Delaware 26-1622110 (State or other jurisdiction of incorporation or organization) (I. ...
Selecta Biosciences (SELB) Investor Presentation - Slideshow
2020-06-03 20:06
SEL-212 for Chronic Refractory Gout - SEL-212 addresses a $1B+ chronic refractory gout market with high unmet need[5,15] - In a Phase 2 dose ranging study, 66% (21/32) of patients achieved SUA levels <6 mg/dL after 20 weeks of once-monthly SEL-212 treatment[17,18] - The company is conducting a head-to-head trial (COMPARE) of SEL-212 against pegloticase in chronic refractory gout patients, with approximately 150 patients enrolled[5,32] - Top-line data from the COMPARE trial is expected in 3Q 2020, and a Phase 3 pivotal program against placebo is planned for 2H 2020[5,64] ImmTOR Platform in Gene Therapy - The company's ImmTOR platform aims to mitigate Neutralizing Antibody (Nab) formation, potentially enabling re-dosing of AAV gene therapies[5] - Preclinical studies suggest ImmTOR can induce antigen-specific immune tolerance, preventing NAb development in mice treated with ImmTOR+AAV vector[42] - A license agreement with AskBio includes upfront payments of $7 million and potential clinical and sales milestone payments of $237 million for Pompe disease[50] - The company expects to commence a human POC trial under the AskBio collaboration in 4Q 2020[64] Financial Status - As of March 31, 2020, the company had $74.264 million in cash, cash equivalents, marketable securities, and restricted cash[61]
Cartesian Therapeutics(RNAC) - 2020 Q1 - Earnings Call Transcript
2020-05-09 17:07
Selecta Biosciences, Inc. (SELB) Q1 2020 Earnings Conference Call May 7, 2020 8:30 AM ET Company Participants Elona Kogan - General Counsel & Corporate Secretary Bradford Dahms - CFO, Principal Financial Officer & Principal Accounting Officer Carsten Brunn - CEO, President & Director Kei Kishimoto - Chief Scientific Officer Conference Call Participants Ellie Merle - Cantor Fitzgerald & Co. Raju Prasad - William Blair & Company Yun Zhong - Janney Montgomery Scott John Newman - Canaccord Genuity Difei Yang - ...
Cartesian Therapeutics(RNAC) - 2020 Q1 - Quarterly Report
2020-05-07 20:17
Financial Performance - Total current assets decreased from $96,667,000 as of December 31, 2019, to $74,440,000 as of March 31, 2020, a decline of approximately 23%[18]. - Grant and collaboration revenue for Q1 2020 was $0, compared to $10,000 in Q1 2019, indicating a significant drop in revenue[20]. - Total operating expenses increased to $18,822,000 in Q1 2020, up from $11,866,000 in Q1 2019, representing a rise of approximately 58%[20]. - Net loss for Q1 2020 was $19,620,000, compared to a net loss of $12,074,000 in Q1 2019, reflecting an increase in losses of about 63%[20]. - The company reported a basic and diluted net loss per share of $0.21 for Q1 2020, compared to $0.31 for Q1 2019[20]. - The accumulated deficit grew to $355,373,000 as of March 31, 2020, from $335,753,000 as of December 31, 2019, an increase of approximately 6%[23]. - The company has not generated any product revenue to date and does not expect to do so in the foreseeable future, relying solely on collaboration and grant revenue[38]. - Management has indicated that substantial additional financing will be required to fund operations and continue executing its strategy, raising doubts about the company's ability to continue as a going concern within one year[39][40]. Cash and Assets - Cash, cash equivalents, and restricted cash at the end of Q1 2020 totaled $74,264,000, down from $91,551,000 at the beginning of the period, a decrease of approximately 19%[28]. - As of March 31, 2020, the company had cash, cash equivalents, and restricted cash totaling $74.3 million, with $1.7 million in restricted cash related to lease commitments[39]. - The company maintained approximately $0.3 million in Russian bank accounts, all held in U.S. dollars[54]. Liabilities and Debt - Total liabilities increased from $91,172,000 as of December 31, 2019, to $97,563,000 as of March 31, 2020, an increase of about 7%[18]. - The company has classified all amounts due under the 2017 Term Loan as current liabilities due to material adverse change clauses[42]. - The outstanding principal balance under the 2017 Term Loan was $16.1 million as of March 31, 2020, down from $18.2 million as of December 31, 2019[122]. - Total minimum debt payments on the 2017 Term Loan as of March 31, 2020, were $17.7 million, with $6.6 million due in 2020[123]. Research and Development - Research and development expenses surged to $14,724,000 in Q1 2020, compared to $7,353,000 in Q1 2019, marking an increase of approximately 100%[20]. - The company has devoted nearly all financial resources to developing its ImmTOR platform and conducting preclinical studies and clinical trials[38]. - Clinical trial expenses are a significant part of R&D costs, with accruals based on estimates of patient enrollment and other factors[76]. Stock and Equity - The company issued 598,977 shares of common stock through an at-the-market offering, generating $1,141,000 in additional paid-in capital[23]. - The Company had a total of 94,723,513 weighted-average common shares and pre-funded warrants outstanding for the three months ended March 31, 2020, compared to 38,447,319 for the same period in 2019[93]. - The total unrecognized compensation expense related to unvested employee stock options was $10.2 million, expected to be recognized over a weighted average period of 2.5 years[153]. - The Company issued 78,583 shares of common stock under the Employee Stock Purchase Plan (ESPP) during the three months ended March 31, 2020[162]. Revenue Recognition - Revenue is recognized when control of promised goods or services is obtained, following a five-step model under ASC 606[67]. - The company generates revenue through grants, collaboration, and license agreements, with arrangements evaluated under ASC 808 and ASC 606[68]. - Milestone payments are evaluated for their relation to performance obligations, with revenue recognized based on the probability of achievement[72]. Strategic Collaborations - The company is actively exploring strategic collaborations to secure non-dilutive capital and accelerate the development of its product candidates[40]. - AskBio has agreed to pay an upfront fee of $7.0 million, with potential additional payments of up to $237.0 million in development, regulatory, and sales milestones[165]. - The Company and AskBio agreed to share research, development, and commercialization costs equally for collaboration products[206]. Accounting and Compliance - The company has assessed the impact of new accounting standards, including ASU 2019-12 and ASU 2016-13, on its consolidated financial statements and disclosures[90][89]. - The Company filed a registration statement with the SEC within the required timeframe, avoiding any pro-rata payments to investors[133]. COVID-19 Impact - The ongoing COVID-19 pandemic introduces significant uncertainty regarding the company's business operations and financial condition[41].
Selecta Biosciences (SELB) Investor Presentation - Slideshow
2020-04-15 19:59
O ato Selecta.. Biosciences Corporate Presentation April 2 0 2 0 SELB Nasdaq Safe harbor/disclaimer Any statements in this presentation about the future expectations, plans and prospects of Selecta Biosciences, Inc. ("the company"), including without limitation, statements regarding the progress of the clinical development of SEL-212, the anticipated timing of the head-to-head trial comparing SEL-212 and Krystexxa® and related data readouts, whether the head-to-head trial with Krystexxa will demonstrate sup ...
Cartesian Therapeutics(RNAC) - 2019 Q4 - Annual Report
2020-03-12 20:18
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2019 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-37798 Selecta Biosciences, Inc. (Exact name of registrant as specified in its charter) | Delawar | | --- | Delaware 26-1622110 (I.R.S. Employer ...
Cartesian Therapeutics(RNAC) - 2019 Q4 - Earnings Call Transcript
2020-03-12 17:42
Selecta Biosciences, Inc. (SELB) Q4 2019 Earnings Conference Call March 12, 2020 8:30 AM ET Company Participants Elona Kogan - General Counsel Carsten Brunn - President and Chief Executive Officer Brad Dahms - Chief Financial Officer Kei Kishimoto - Chief Scientific Officer Conference Call Participants Ellie Merle - Cantor Fitzgerald Raju Prasad - William Blair Chad Messer - Needham & Company John Newman - Canaccord Yun Zhong - Janney Difei Yang - Mizuho Securities USA Operator Good morning and welcome to ...
Selecta Biosciences (SELB) Investor Presentation - Slideshow
2020-02-27 16:21
O ရှိ Selecta.. Biosciences Corporate Presentation February 2020 Nasdaq SELB Safe harbor/disclaimer Any statements in this presentation about the future expectations, plans and prospects of Selecta Biosciences, Inc. ("the company"), including without limitation, statements regarding the progress of the clinical development of SEL-212, the anticipated timing of the head-to-head trial comparing SEL-212 and Krystexxa® and related data readouts, whether the head-to-head trial with Krystexxa will demonstrate sup ...