On August 12, 2021 Instil Bio, Inc. ("Instil") (NASDAQ: TIL), a clinical-stage biopharmaceutical company focused on developing tumor infiltrating lymphocyte, or TIL, therapies for the treatment of patients with cancer, reported its second quarter 2021 financial results and provided a corporate update (Press release, Instil Bio, AUG 12, 2021, View Source [SID1234586425]).

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"We confirm our commitment to initiating a Phase 2 trial of ITIL-168 in advanced melanoma in the second half of 2021," said Bronson Crouch, Chief Executive Officer of Instil. "With the installation and ongoing qualification of modular clean room pods at our Tarzana, California facility and our progress toward activating additional manufacturing capabilities in Manchester, U.K., we expect increased clinical manufacturing capacity in late 2021 and early 2022 to support our clinical development plans for ITIL-168 and ITIL-306. Our commitment to innovation in manufacturing continues with the development of a shortened 21-day manufacturing process with robust levels of TIL transduction efficiency for ITIL-306, our first genetically engineered CoStAR-TIL. We expect to pursue further enhancements to both ITIL-168 and ITIL-306 manufacturing processes in the future."

Second Quarter 2021 Highlights and Anticipated Milestones:

Clinical Development:

Presented Clinical Data in Advanced Melanoma at AACR (Free AACR Whitepaper): Instil presented clinical data demonstrating a 67% objective response rate and 19% complete response rate from a compassionate use program of TILs for the treatment of metastatic melanoma as a late-breaking e-Poster at the AACR (Free AACR Whitepaper) virtual meeting in April 2021.

Orphan Drug Designation: On April 27, 2021, ITIL-168 received orphan drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of melanoma stages IIB to IV.

Phase 2 Clinical Trial Initiation of ITIL-168: Instil expects to start a Phase 2 clinical trial of ITIL-168 for the treatment of advanced melanoma in the second half of 2021. Topline safety and efficacy data would be expected in 2023, followed by submission of a BLA to the FDA and a Marketing Authorization Application to the European Medicines Agency expected in 2023 and 2024, respectively.

Phase 1 Clinical Trial Initiation of ITIL-306: Instil expects to start a Phase 1 clinical trial of ITIL-306 for the treatment of FOLR1-expressing cancer in the first half of 2022.
Manufacturing and Technical Operations:

Facility Readiness for Clinical Trials: Current manufacturing capacity in the U.K. is sufficient to support capacity needs at the start of the expected upcoming Phase 2 clinical trial of ITIL-168. Further expansion of our U.K. manufacturing capacity is expected later this year. Instil has also installed and begun qualification of its modular clean room pods at its Tarzana, California facility. These pods will support U.S. regional manufacturing and are expected to begin producing clinical batches in the first half of 2022.

ITIL-306 Manufacturing Process: Instil’s focus on continued improvements in manufacturing is highlighted by the development of a 21-day manufacturing process for ITIL-306. This process is capable of achieving high TIL transduction efficiencies that are well in excess of published literature.
Second Quarter 2021 Financial and Operating Results:

As of June 30, 2021, cash and cash equivalents totaled $566.7 million, compared to $241.7 million as of December 31, 2020. The Company expects that its cash and cash equivalents as of June 30, 2021 will enable it to fund its operating plan into 2023.

Research and development expenses were $21.2 million and $35.6 million for the three and six months ended June 30, 2021, compared to $2.2 million and $4.2 million for the three and six months ended June 30, 2020.

General and administrative expenses were $14.2 million and $23.2 million for the three and six months ended June 30, 2021, compared to $2.4 million and $4.3 million for the three and six months ended June 30, 2020.

On August 12, 2021 Calliditas Therapeutics AB (publ) ("Calliditas" or the "Company") (Nasdaq Stockholm – CALTX; Nasdaq – CALT), a biopharma company focused on identifying, developing and commercializing novel treatments in orphan indications, reported its intention to carry out a directed issue of common shares of approximately SEK 300 million to Swedish and international institutional investors and sector specialist investors (the "Issue") (Press release, Calliditas Therapeutics, AUG 12, 2021, View Source [SID1234586424]).

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The Issue in brief

The Issue is intended to be carried out with deviation from the shareholders’ preferential rights in accordance with the authorization granted by the Annual General Meeting on May 27, 2021. The subscription price and the total number of new shares in the Issue will be determined through an accelerated book building procedure, which will commence immediately following this press release. The completion, pricing and allocation of the new shares is expected to take place before the beginning of trading on Nasdaq Stockholm at 09.00 CEST on August 13, 2021. By establishing the subscription price in the Issue through an accelerated book building procedure, it is the assessment of the Board of Directors that the subscription price will accurately reflect current market conditions and demand. The closing, pricing and allocation in the book building procedure is at the discretion of the Company and may be cancelled at any time. The Company will announce the outcome of the Issue in a subsequent press release after the book building procedure has been completed.

The Company intends to use the net proceeds from the Issue for:

ongoing clinical development;
pre-commercial development in the United States;
commercial activities for Nefecon, if approved for marketing by the FDA later this year; and
general corporate purposes.
The Company believes that using the flexibility provided by a non-pre-emptive placing is the most appropriate and optimal transaction structure at this time in order to raise capital for the development of ongoing projects in a time and cost-effective manner. Moreover, the Company will further strengthen the shareholder base with Swedish and international institutional investors and sector specialist investors.

In connection with the Issue, the Company has agreed to a lock-up undertaking, with customary exceptions, on future share issuances for a period of 90 days. In addition, members of the Board of Directors and management of Calliditas, who owns shares or warrants, have, in connection with the Issue, agreed not to sell any shares in the Company during a lock-up period of 90 days subject to customary exceptions.

Advisers

In conjunction with the Issue, the Company has engaged Jefferies GmbH, Carnegie Investment Bank AB (publ) and Kempen & Co as Joint Global Coordinators and Joint Bookrunners. Vinge act as legal adviser to the Company and Baker McKenzie act as legal adviser to the Banks.

The information in the press release is inside information that Calliditas is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons above, on August 12, 2021 at 17:57 (CEST).

On August 12, 2021 Ikena Oncology, Inc. (Nasdaq: IKNA, "Ikena"), a targeted oncology company focused on developing novel cancer therapies targeting key signaling pathways, reported financial results for the quarter that ended June 30, 2021 (Press release, Ikena Oncology, AUG 12, 2021, View Source [SID1234586423]). The Company also shared updates on several pipeline programs targeting tumor signaling pathways, including Hippo, RAS, and the tumor microenvironment.

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"In recent months, the Ikena team has continued to generate data on the important targets we are exploring and our development candidates. This work has further elucidated the potential of TEAD inhibition as a monotherapy and in combination with other targeted therapies, and enables us to further refine the clinical development strategy for IK-930, our novel TEAD inhibitor," said Mark Manfredi, PhD, Chief Executive Officer of Ikena Oncology. "We look forward to sharing these and more updates as our data matures and we make strides towards our goal to transform the landscape of cancer treatment to a targeted, patient-focused treatment paradigm."

Ikena is also evaluating our novel AHR antagonist, IK-175, in a Phase I clinical trial as a monotherapy and in combination with nivolumab for the treatment of advanced or metastatic solid tumors, including in urothelial carcinoma, a type of bladder cancer where there is a significant unmet need. After completing the monotherapy dose escalation we are progressing the expansion cohort and enrolling additional urothelial carcinoma patients to continue evaluating IK-175 as a monotherapy and the path towards proof-of-concept in this patient population.

"The emerging clinical data observed for IK-175 monotherapy in urothelial carcinoma and the expansion of the cohort are great steps toward establishing proof of concept. These patients have very limited options for treatment, and we are hopeful that IK-175 could have significant impact in this setting," said Sergio Santillana, MD, Chief Medical Officer at Ikena. "The monotherapy cohort expansion is an encouraging development for the Ikena team and ultimately for the patients whose cancer could be treated with this novel therapy. We look forward to generating additional data and providing an update on safety and preliminary anti-tumor activity of IK-175 at a medical conference in 2022."

Recent Pipeline Progress and Corporate Update

IK-930: TEAD Inhibitor in the Hippo Signaling Pathway in IND-enabling Studies
IND-enabling studies continued to progress and the IND submission is on track for the end of 2021.
Translational and preclinical data will be shared at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) 2021 Virtual AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) taking place October 7-10, 2021.
Virtual Poster Presentation of IK-930 indication selection methodology and data, highlighting a novel method to assess activation across the Hippo pathway and the rationale behind mesothelioma as a cancer type that could benefit from TEAD inhibition as a monotherapy
Virtual Poster Presentation of the tumor growth inhibition observed in in vivo preclinical models of lung and colon cancer with IK-930 combined with inhibition of MEK and EGFR, separately and in triplet
IK-175: Clinical Stage AHR Antagonist Partnered with Bristol Myers Squibb (BMS)
Ikena is expanding the monotherapy bladder cancer cohort to treat additional patients in the current dose expansion cohort per protocol of the ongoing Phase 1 clinical trial.
Translational and preclinical data will be shared at scientific conferences in the second half of 2021.
Clinical data presentation planned for a major medical conference in 2022.
IK-412: Novel Enzymatic Therapeutic Degrading Kynurenine Partnered with BMS
Ikena was notified in the second quarter that a key component required in the manufacturing of IK-412 is also required for the manufacturing of COVID-19 vaccines and therapies. As a result, the availability of the component for purposes other than vaccine production is extremely limited in the near-term.
This situation impacted our manufacturing lead times, delaying the planned IND submission for IK-412.
Updated guidance on IND submission timing will be provided when material supply of this key component can be reliably projected.
We continue to work closely with our supplier and contract manufacturing organization, as well as our partner BMS, to advance the program toward IND submission.
IND-enabling studies of IK-412 continue to progress as planned.
Additional Pipeline Programs Continue to Progress
Financial Results for the Quarter Ended June 30, 2021

As of June 30, 2021, the Company had cash and cash equivalents totaling $264.0 million, which will fund operations through 2023. Net cash used in operations was $15.7 million for the second quarter of 2021 as compared to $7.7 million for the second quarter of 2020.

Research and development expenses for the second quarter 2021 were $11.4 million, compared to $6.3 million for the second quarter 2020. The increase in R&D expense was primarily related to on-going IND-enabling studies and manufacturing development costs for IK-930, ongoing IND-enabling studies for IK-412, increased research activities of other discovery stage programs and increased personnel expenses due to increase in headcount. The increase in research and development expenses was offset by a decrease in expense attributable to drug manufacturing of IK-175 and a decrease in clinical activities for IK-007.

General and administrative expenses for the second quarter were $4.9 million, compared to $1.8 million for the second quarter 2020. The increase in G&A expense was primarily related to compensation expense due to an increase in headcount, as well as general increases in audit, legal and consulting expenses to support our operations as a public company.

Net loss for the second quarter 2021 was $12.7 million, compared to $5.0 million for the second quarter 2020, driven by increases in research and development and general and administrative expenses.

On August 12, 2021 Prelude Therapeutics Inc. (Nasdaq: PRLD), a clinical-stage precision oncology company, reported its financial results for the second quarter ended June 30, 2021 and provided an update on recent clinical and development pipeline progress (Press release, Prelude Therapeutics, AUG 12, 2021, View Source [SID1234586422]).

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"Prelude’s second quarter was marked by solid operational execution, continued innovation, and organizational growth. We made meaningful progress advancing our pipeline of novel, internally discovered precision oncology therapeutics aimed at addressing several cancers with high unmet need," said Kris Vaddi, PhD, Chief Executive Officer. "Our ongoing clinical programs, including the Phase 1 trials of PRT543 and PRT811, for which we expect to present clinical data in the fourth quarter, and PRT1419 are advancing as planned. In addition, we continue to maintain focus on the advancement of our preclinical and discovery programs, with an IND application submission for PRT2527, our CDK9 inhibitor, and initiation of IND-enabling studies for our discovery programs expected by year end."

Recent Highlights and Upcoming Milestones

PRT543

Dose Expansion Portion of Phase 1 Trial Ongoing; Data from Dose Escalation Portion to be Presented at the AACR (Free AACR Whitepaper)-NCI-EORTC Annual Meeting: The Company will present data from the dose escalation portion of the Phase 1 trial in unselected patient populations, including safety, PK and PD data and markers of target engagement, at the AACR (Free AACR Whitepaper)-NCI-EORTC Annual Meeting in October. PRT543 is designed to be a potent and selective inhibitor of PRMT5. Patient enrollment is continuing in specific biomarker-selected solid tumor and hematologic malignancy expansion cohorts representing cancers of high unmet need, including adenoid cystic carcinoma (ACC), spliceosome mutated and HRD+ solid tumors and spliceosome-mutated myeloid malignancies. The Company expects to present data from the expansion cohorts at medical meetings throughout 2022.
PRT811

Dose Expansion Portion of Phase 1 Trial Expected to Commence in 3Q21; Data from Dose Escalation Portion to be Presented at the AACR (Free AACR Whitepaper)-NCI-EORTC Annual Meeting: The Company will present data from the dose escalation portion of the Phase 1 trial in unselected patient populations, including safety, PK and PD data and markers of target engagement, at the AACR (Free AACR Whitepaper)-NCI-EORTC Annual Meeting in October. PRT811 is designed to be a potent, selective, and brain penetrant PRMT5 inhibitor. Prelude anticipates beginning the dose expansion portion of the Phase 1 trial in the third quarter in selected patients with central nervous system cancers, including high grade gliomas and CNS metastatic cancers. The Company expects to present data from the expansion cohorts at medical meetings throughout 2022.
PRT1419

Oral Formulation: Dose Escalation Portion of Phase 1 Trial Ongoing. The dose escalation portion of the Company’s first-in-human Phase 1 study of oral PRT1419, the Company’s third clinical candidate, in patients with relapsed/refractory hematologic malignancies, including acute myeloid leukemia and high-risk myelodysplastic syndromes, remains ongoing. PRT1419 is designed to be an orally available, potent, and selective MCL1 inhibitor. The Company expects to add dose expansion and combination cohorts to the Phase 1 clinical trial in the second half of 2021.

IV Formulation: Dose Escalation Portion of Phase 1 Trial is Now Underway. The Phase 1 trial of an intravenous (IV) formulation of PRT1419, which leverages the optimized physicochemical properties of PRT1419, is now underway in patients with solid tumors.
Discovery Programs

Earlier-Stage Candidates Expected to Advance in 2021. The Company remains on track to submit an Investigational New Drug (IND) application in 2021 for PRT2527, which is designed to be a potent and selective CDK9 inhibitor. In addition, the Company continues to expect to initiate IND-enabling studies for PRT-SCA2, which is designed to be a SMARCA2 protein degrader, by the end of the year.
Corporate Updates

Martin Babler Appointed to Board of Directors. In July 2021, the Company announced the appointment of Martin Babler to its Board of Directors. Mr. Babler brings to Prelude over 25 years of pharmaceutical and biotech experience, most recently serving as President and Chief Executive Officer of Principia Biopharma until its acquisition by Sanofi S.A. in October 2020. Mr. Babler will serve as a member of the audit committee of the Board.

Michele Porreca Appointed as Chief People Officer. Prelude reported the recent appointment of Michele Porreca as Chief People Officer. In this newly created role, she will lead all aspects of the Company’s human resources management, including, talent management and strategy, organizational effectiveness, total rewards, culture, inclusion, and employee communications. Ms. Porreca brings to Prelude over 20 years of human resources experience, most recently serving as Chief Human Resources Officer at Nabriva Therapeutics.
Second Quarter 2021 Financial Results

Cash and Cash Equivalents: Cash and cash equivalents as of June 30, 2021 were $343.1 million.

Research and Development (R&D) Expenses: For the second quarter of 2021, R&D expense increased by $12.6 million to $22.4 million for the three months ended June 30, 2021 from $9.8 million for the three months ended June 30, 2020. The increase was mainly due to increased clinical research costs for the PRT543, PRT811 and PRT1419 (Oral and IV) programs, and increased chemistry, manufacturing and other costs for those trials.

General and Administrative (G&A) Expenses: For the second quarter of 2021, G&A expense increased by $3.9 million to $5.5 million for the three months ended June 30, 2021 from $1.6 million for the three months ended June 30, 2020. The increase was primarily due to an increase in personnel related expense due to an increase in employee headcount and an increase in the Company’s professional fees as a result of expanded operations to support research and development efforts as well as incurred additional costs to operate as a public company.

Net Loss: For the second quarter of 2021, net loss was $26.9 million, or $0.58 per share, compared with a net loss of $11.4 million, or $5.50 per share, for the same period in 2020.

Financial Guidance: The Company believes that its current cash and cash equivalents will be sufficient to fund operating expenses and capital expenditure requirements into mid-2023.

On August 12, 2021 Synlogic, Inc. (Nasdaq: SYBX), a clinical stage company bringing the transformative potential of synthetic biology to medicine, reported financial results for the second quarter ended June 30, 2021, and provided an update on its clinical and preclinical programs (Press release, Synlogic, AUG 12, 2021, View Source [SID1234586421]).

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"We are executing across our co-lead metabolic programs and advancing towards proof of concept readouts of our Synthetic Biotic medicines for the treatment of Phenylketonuria and Enteric Hyperoxaluria," said Aoife Brennan, M.B. Ch.B., Synlogic’s President and Chief Executive Officer. "With a next-generation strain in a Phase 1 study for the treatment of Phenylketonuria, a strategic collaboration in place to expand our IBD pipeline and an advancing pre-clinical pipeline of metabolic disease programs, we have a robust set of potential therapies that could provide meaningful benefit to patients. We look forward to communicating results and next steps over the coming months."

Quarter Highlights

The Metabolic Portfolio:

Proof of concept data of SYNB1618 for the treatment of Phenylketonuria (PKU) anticipated in second half of 2021, Phase 1 study of SYNB1934 initiated.

The SynPheny-1 Phase 2 trial of SYNB1618 continues to progress.
SynPheny-1 is designed to evaluate plasma phenylalanine (Phe) lowering of a solid oral formulation of SYNB1618 in adult PKU patients who do not benefit from, or do not tolerate, existing therapies.
In July, the Company initiated a Phase 1 study of SYNB1934, a next-generation strain designed for the treatment of PKU, to evaluate safety, tolerability and head-to-head comparison of Phe-consumption biomarkers between SYNB1934 and SYNB1618.
SYNB1934, an evolved strain of SYNB1618 in the PKU portfolio, has the potential to provide increased benefit to patients living with PKU.
Preclinical in vivo and in vitro studies demonstrated a greater than 2-fold improvement in the ability of SYNB1934 to consume and break down Phe compared to SYNB1618.
Papers published in the journals Nature Metabolism and Communications Biology detail findings from a first-in-human study of SYNB1618 and the development of a mechanistic model to predict the function of Synthetic Biotic medicines in healthy volunteers and PKU patients.
Data from the first-in-human study of SYNB1618 showed dose-responsive, non-saturated increases in gastrointestinal consumption of Phe by SYNB1618.
These data add to the growing body of scientific research demonstrating the therapeutic potential of Synthetic Biotic medicines for the treatment of PKU.
SYNB1618 and SYNB1934 are orally administered Synthetic Biotic medicines being developed as potential treatments for PKU. They are intended to address the needs of patients of all age groups through the consumption of Phe in the gastrointestinal (GI) tract, which has the potential to lower blood Phe levels and enable the consumption of more natural protein in the diet.

Proof of concept data of SYNB8802 for the treatment of Enteric Hyperoxaluria anticipated in second half of 2021.

SYNB8802 demonstrated proof of mechanism in Part A of an ongoing Phase 1 trial, with evidence of urinary oxalate lowering in a Dietary Hyperoxaluria model in healthy volunteers given a high oxalate diet.
Urinary oxalate lowering by SYNB8802 was robust and dose-dependent.
The 3e11 dose is undergoing evaluation in Part B of the study in patients with Enteric Hyperoxaluria.
This dose was well-tolerated and resulted in a 28.6% (90% CI: -42.4 to -11.6) reduction in urinary oxalate as measured by a change from baseline compared to placebo.
Part B of the study is continuing with the evaluation of SYNB8802 in patients with Enteric Hyperoxaluria secondary to Roux-en-Y gastric bypass surgery.
Data on the development of SYNB8802 was presented at the Synthetic Biology: Engineering, Evolution & Design (SEED) conference in June 2021.
SYNB8802 is an orally administered Synthetic Biotic medicine being developed as a potential treatment for Enteric Hyperoxaluria. SYNB8802 is designed to consume oxalate in the GI tract to prevent the increased absorption of oxalate in Enteric Hyperoxaluria patients.

Enteric Hyperoxaluria results in dangerously high urinary oxalate levels causing progressive kidney damage, kidney stone formation, and nephrocalcinosis. Enteric Hyperoxaluria has no approved treatment options. Approximately 100,000 patients in the US suffer from chronic and recurrent kidney stones as a result of severe Enteric Hyperoxaluria.

The Immunomodulation Portfolio:

Progression of SYNB1891 in combination arm dosing with PD-L1 checkpoint inhibitor in Phase 1 study in patients with advanced solid tumors or lymphoma.

SYNB1891 is currently being evaluated in a Phase 1 study that has two parts: Part A is a monotherapy arm that has enrolled six dose cohorts to date. Part B is a combination arm with SYNB1891 and the PD-L1 checkpoint inhibitor atezolizumab that has enrolled two dose cohorts to date.
The study is ongoing. Mature combination therapy data is expected by the end of the year.
SYNB1891 is an investigational drug for the intra-tumoral treatment of solid tumors and lymphoma, composed of an engineered Synthetic Biotic strain of E. coli Nissle that produces cyclic di-AMP (CDA), a stimulator of the STING (STimulator of INterferon Genes) pathway.

Advancement of preclinical programs in Inflammatory Bowel Disease.

In June, Synlogic and Roche entered into a research collaboration agreement for the discovery of a novel Synthetic Biotic medicine for the treatment of inflammatory bowel disease (IBD). Under the terms of the agreement, Synlogic and Roche will collaborate to develop a Synthetic Biotic medicine addressing an undisclosed novel target in IBD.
Data on novel Synthetic Biotic approaches for the treatment of IBD was presented at Digestive Disease Week (DDW) in May 2021.
Corporate Update:

Synlogic strengthens Balance Sheet and advances synthetic biology capabilities.

In April, Synlogic completed an underwritten public offering of 11.5 million shares, resulting in net proceeds to Synlogic of approximately $32.6 million.
Synlogic and Ginkgo Bioworks continue to advance their long-term strategic platform collaboration that provides expanded synthetic biology capabilities to Synlogic with multiple undisclosed metabolic programs now in preclinical stages of development. Additional information on these programs will be provided over the course of the year.
Second Quarter 2021 Financial Results

As of June 30, 2021, Synlogic had cash, cash equivalents, and short-term investments of $115.5 million.

For the three months ended June 30, 2021, Synlogic reported a consolidated net loss of $14.5 million, or $0.28 per share, compared to a consolidated net loss of $15.5 million, or $0.44 per share, for the corresponding period in 2020.

Research and development expenses were $10.7 million for the three months ended June 30, 2021 compared to $12.9 million for the corresponding period in 2020.

General and administrative expenses for the three months ended June 30, 2021 were $4.1 million compared to $3.5 million for the corresponding period in 2020.

Revenue was $0.2 million for the three months ended June 30, 2021, compared to $0.4 million for the corresponding period in 2020. Revenue for the three months ended June 30, 2021 was due to the collaboration with Roche, for the discovery of a novel Synthetic Biotic medicine for treatment of inflammatory bowel disease (IBD). Under the terms of the agreement, Synlogic and Roche will collaborate to develop a Synthetic Biotic medicine addressing an undisclosed novel target in IBD. Revenue for the three months ended June 30, 2020 was due to the prior collaboration with AbbVie to develop Synthetic Biotic medicines for the treatment of inflammatory bowel disease, which was terminated in May 2020.

Financial Outlook

Based upon its current operating plan and balance sheet as of June 30, 2021 Synlogic expects to have sufficient cash to be able to fund the base operating plan into the second half of 2023.

Conference Call & Webcast Information

Synlogic will host a conference call and live webcast at 8:30 a.m. ET today, Thursday, August 12, 2021. To access the live webcast, please visit the "Event Calendar" page within the Investors and Media section of the Synlogic website. Investors may listen to the call by dialing +1 (844) 815-2882 from locations in the United States or +1 (213) 660-0926 from outside the United States. The conference ID number is 7586239. A replay will be available for 30 days on the Investors and Media section of the Synlogic website.