On August 12, 2021 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, reported financial results for the second quarter of 2021 (Press release, CASI Pharmaceuticals, AUG 12, 2021, View Source [SID1234586454]).

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Wei-Wu He, Ph.D., CASI’s Chairman and Chief Executive Officer, commented, "We are pleased to report $7.1 million EVOMELA revenues for the quarter. Based on the current trend, we are revising our guidance for full-year 2021 revenue growth to exceed 80% over 2020. We are proud of our commercial franchise execution for EVOMELA and have expanded to over 100 FTEs on the commercial and marketing teams. In addition to the continued EVOMELA revenue growth, we achieved dosing of first patient of CID-103 in our Phase 1 clinical trial for relapse or refectory multiple myeloma. CID-103 has previously shown encouraging preclinical efficacy, a favorable preclinical safety profile, and greater antibody-dependence cellular cytotoxicity activity over other anti-CD38 mAbs, and we are hopeful this will translate into patient benefit."

Dr. He continued, "We are thrilled with the progress we continue to see throughout our hematology oncology pipeline. Our partner, Juventas, has completed CNCT19’s (CD19 CAR-T) Phase 1 studies of B-ALL and B-NHL in China. The Phase 2 B-NHL and B-ALL registration studies of CNCT19 are currently enrolling in China. Additionally, BioInvent recently announced that the China National Intellectual Property Administration (CNIPA) has issued a notice of allowance, informing the company that a patent application relating to the anti-FcγRllB antibody BI-1206 is expected to be granted. Together with BioInvent we plan to continue to develop BI-1206 in both hematological malignancies and solid tumors, with CASI responsible for development and commercialization in Greater China."

Second Quarter 2021 Financial Results

Revenues consist of product sales of EVOMELA that launched during August 2019. Revenue was $7.1 million for the three months ended June 30, 2021 compared to $2.6 million for the three months ended June 30, 2020. Revenues increased by 173% in the second quarter of 2021 as compared to same quarter in 2020 due to the continued growth in EVOMELA sales.

Costs of revenues were $2.9 million for the three months ended June 30, 2021, compared to $2.5 million for the three months ended June 30, 2020, which includes royalty payment of $1.4 million and $0.5 million for the same period. Costs of revenues excluding royalty were $1.5 million and $2.0 million for the three months ended June 30, 2021, and 2020. Costs of revenues, excluding royalty as a percentage of revenues, decreased significantly in the three months ended June 30, 2021, compared within the three months ended June 30, 2020, due to the new alternate manufacturer now in place, resulting in a considerable decrease in the unit cost of inventories of EVOMELA.

General and administrative expenses for the three months ended June 30, 2021 were $5.4 million, compared with $4.1 million for the three months ended June 30, 2020.

Selling and marketing expenses for the three months ended June 30, 2021 were $3.4 million, compared with $1.6 million for the three months ended June 30, 2020. The increase in selling and marketing expenses was due to expansion of sales team in China in 2021.

Acquired in-process R&D expenses for the three months ended June 30, 2021 was $1.06 million, compared to $0 million for the three months ended June 30, 2020. In June 2021, the Company achieved the First-Patient-In (FPI) in the Phase 1 dose escalation and expansion study of CID-103, and made $750,000 milestone payment and accrued €250,000 ($305,000) payment under the terms of the agreement.

Net loss for the three months ended June 30, 2021 was $6.7 million compared to $8.5 million for the three months ended June 30, 2020 due to significant revenue increase. As of June 30, 2021, CASI had cash and cash equivalents of $60.4 million compared to $57.1 million as of December 31, 2020.
Further information regarding the Company, including its Quarterly Report on Form 10-Q for the quarter ended June 30, 2021, can be found at www.casipharmaceuticals.com.

Conference Call

The Company will host a conference call reviewing the second quarter highlights today at 8:00 a.m. ET. The conference call can be accessed by dialing (833) 420-0382 (U.S.), (800) 870-0181 (China), (400) 682-8629 (China, domestic), 58086567 (Hong Kong) to listen to the live conference call. The conference ID number for the live call is 5639775. Participants dialing in via International Toll-Free Service (ITFS) numbers will be required to provide the following passcode to join the conference call: 8336474459, 6025859887.

This call will be recorded and available for replay by dialing (800) 859-2056 (U.S.) or (404) 537-3406 (international) and enter 5639775 to access the replay.

On August 12, 2021 iTeos Therapeutics, Inc. (Nasdaq: ITOS), a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of highly differentiated immuno-oncology therapeutics for patients, reported financial results for the second quarter ended June 30, 2021 and provided recent business highlights (Press release, iTeos Therapeutics, AUG 12, 2021, View Source [SID1234586471]).

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"The last few months have been a transformative time for iTeos, as we achieved significant milestones that will shape the future of our company and help us in our mission to discover, develop and deliver therapies that will improve the lives of people with cancer. I am incredibly proud of our continued execution with our clinical programs and strategic initiatives," said Michel Detheux, PhD, president, and chief executive officer of iTeos. "For our TIGIT program, we announced a transformational strategic collaboration with GSK that will allow us to combine our resources and expand and accelerate the development program for EOS-448 through rapid evaluation of dostarlimab and triplet combinations beginning in the coming months. With the rights iTeos retained, we can maximize the value of EOS-448 for patients and our shareholders. In addition to expanding our TIGIT program, the GSK collaboration is also an important validation for our team’s ability to identify and pursue best-in-class anti-tumor drug candidates. To that end, we are excited to advance inupadenant, our second clinical-stage program, which has demonstrated in a Phase 1 trial durable responses in two patients with checkpoint inhibitor resistant tumors, good tolerability and a potentially predictive biomarker which will help to drive tumor and patient selection in upcoming trials. In the coming months, we look forward to advancing inupadenant into proof-of-concept trials in several indications."

Program Highlights

EOS-448: IgG1 anti-TIGIT monoclonal antibody designed to engage the Fc gamma receptor (FcγR) and to enhance anti-tumor responses through a multifaceted mechanism of action.

In June 2021, iTeos and GSK announced an agreement to co-develop and co-commercialize EOS-448. As part of the agreement, iTeos received a $625 million upfront payment and is eligible to receive up to $1.45 billion in potential milestone payments upon the achievement of certain development and commercial milestones. GSK is responsible for 60% of expense in the global development plan. The companies will co-commercialize and equally split profits in the U.S. iTeos will be eligible to receive royalties on sales outside of the U.S.
In April 2021, the Company presented initial clinical and safety data from the monotherapy dose escalation part of the Phase 1 trial in adult patients with advanced solid tumors at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. These preliminary data show the drug was well-tolerated across dose levels, caused depletion of TIGIT-expressing Treg cells in the blood, providing evidence of target and FcyR engagement, and had encouraging early signs of anti-cancer activity in Phase 1, including one partial response in a pembrolizumab-resistant metastatic melanoma patient.
The Company is working with GSK to rapidly initiate trials of EOS-448 in combinations including with Jemperli (dostarlimab).
iTeos will also advance EOS-448 in combination with pembrolizumab and with inupadenant in patients with solid tumors, and as a monotherapy and in combination with an Immunomodulatory Drug (IMiD) in patients with multiple myeloma.
Inupadenant (EOS-850): Designed as an insurmountable and highly selective small molecule antagonist of the adenosine A2A receptor, the only high-affinity adenosine receptor expressed on different immune cells found in the tumor micro-environment.

In June 2021, the company presented updated data from 43 patients in both the single-agent dose-escalation and expansion portions of the ongoing open-label Phase 1/2a clinical trial, including results from pre-treatment tumor biopsy analyses, as part of an e-poster at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. Preliminary tumor biopsy analyses demonstrate that A2AR expression assessed using a proprietary assay, in patients with solid tumors treated with single agent inupadenant is associated with clinical outcomes. Results also provide evidence of durable antitumor activity in patients with advanced solid tumors and indicate a safety and tolerability profile consistent with previously reported data.
Based on the encouraging monotherapy results, iTeos plans to initiate inupadenant proof-of-concept trials in several indications and will continue to use A2AR and other potential biomarkers to select indications and patients most likely to benefit from treatment.
Preclinical programs: iTeos continues to progress research programs focused on additional targets that address pathways of immunosuppression and complement the mechanism of action of the A2AR and TIGIT programs. iTeos expects to nominate an additional product candidate which inhibits a novel target in the adenosine pathway for Investigational New Drug-enabling studies before the end of 2021.

Upcoming Events

KBC Securities Life Sciences Conference, September 7
Wells Fargo Healthcare Conference, September 9-10
Morgan Stanley Global Healthcare Conference, September 9-10 and 13-15
H.C. Wainwright Global Investment Conference, September 13-15
Cantor Fitzgerald Global Healthcare Conference, September 27-30
Second Quarter 2021 Financial Results

Cash Position: The Company had cash and cash equivalents of $302.9 million as of June 30, 2021, compared to $136.9 million as of June 30, 2020. Following receipt of the upfront payment from GSK pursuant to the Company’s Collaboration and License Agreement earlier in August 2021, the Company believes that its existing cash and cash equivalents would enable it to fund operating expenses and capital expenditure requirements into 2026.
Research and Development (R&D) Expenses: R&D expenses were $14.2 million for the quarter ended June 30, 2021, compared to $6.1 million for the same quarter of 2020. This increase was primarily due to an increase in activities related to clinical trials for EOS-448 and inupadenant and increased headcount.
General and Administrative (G&A) Expenses: G&A expenses were $15.1 million for the quarter ended June 30, 2021, compared to $2.4 million for the same quarter of 2020. This increase was primarily due to increased headcount, professional fees and other costs associated with becoming a public company, along with one-time legal and advisory fees incurred by the Company associated with the Collaboration and License Agreement with GSK to co-develop and co-commercialize EOS-448.
Net Loss: Net loss attributable to common shareholders was $26.5 million, or a net loss of $0.75 per basic and diluted share, for the quarter ended June 30, 2021, as compared to $10.3 million, or a net loss of $29.49 per basic and diluted share, for the same quarter of 2020.
Conference Call Details:
iTeos Therapeutics will host a conference call and webcast today at 8:00am ET. To access the live event, please use the following link and you will receive access details via email: View Source

A live audio webcast of the event will also be accessible from the Events page of the Company’s website at View Source The archived webcast will be available approximately two hours after the completion of the event and for 30 days following the call.

On August 12, 2021 Sosei Group Corporation ("the Company") (TSE: 4565) reported its consolidated results for the second quarter and first half ended 30 June 2021 (Press release, Sosei Heptares, AUG 12, 2021, View Source [SID1234586488]).

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The Company will host a webinar presentation today with Shinichi Tamura, Chairman, President and CEO, Chris Cargill, Group Chief Operating and Financial Officer, and Dr. Tim Tasker, Chief Medical Officer, at 5 pm JST (9 am BST). The webinar is open to all existing and potential investors as well as sell-/buy-side analysts and will consist of a presentation followed by a Q&A session. Please click here to register and receive a link to access the webinar.

Presentation slides will be made available by 4 pm JST (8 am BST) on the 12 August 2021 through the investor section of the Company’s Home Page here.

Shinichi Tamura, Chairman, President and CEO of Sosei Heptares, commented: "We are pleased with the progress we have made during 2021. This year’s focus is on increasing investment in R&D and in strategic growth initiatives, as we continue to explore revenue-generating business opportunities for acquisition to support our medium-term plan for corporate expansion. Investments in R&D are focused on advancing our portfolio of muscarinic agonists for schizophrenia and other neurological disorders, and to partner this portfolio in the near term with a well-capitalized global partner to accelerate late-stage development of these programs. In addition, we continue to make good progress advancing our inhouse and partnered programs, as well as enhancing our world-leading platform for identifying and exploiting new druggable target opportunities. We are confident that we have the right overall corporate strategy to deliver continued success and value creation for all stakeholders."

Operational Highlights for H1 2021

Worldwide rights to out-licensed muscarinic agonist programs regained from AbbVie/Allergan – independent review of programs has completed, with increased investment allocated to advance the HTL’878 selective muscarinic M4 receptor agonist through clinical studies and build value ahead of future partnering. HTL’878 represents a unique opportunity to develop a novel therapeutic with a new mechanism of action for neurological disorders including schizophrenia. Negotiations for collaborations on this and other muscarinic programs are now in progress.
Third novel drug candidate resulting from multi-target drug discovery collaboration with Pfizer entered clinical trials – dosing of first subject with PF-07258669 (an MC4 receptor antagonist for Anorexia) by Pfizer triggered a US$5 million payment to Sosei Heptares.
Three milestone payments totalling US$6 million received from Genentech during H1 2021 – milestones achieved from the delivery of StaR proteins based on nominated targets under the 2019 multi-target agreement.
Sosei Heptares initiated a Phase 1 trial with the 10th candidate to be generated from its structure-based drug design (SBDD) platform – first healthy subjects dosed with HTL’22562 (also known as BHV3100), a novel, small molecule CGRP receptor antagonist targeting CGRP-mediated disorders, under its collaboration with Biohaven.
Spin-off company Orexia Therapeutics merged into Centessa Pharmaceuticals, a new asset-centric company – Orexia became one of ten private companies merged into Centessa, which launched in February 2021 and raised US$250 million. Sosei Heptares’ equity holding in Orexia was converted into a proportional shareholding (1.03%) in Centessa, which completed an Initial Public Offering on Nasdaq Global Market in June 2021 at a market capitalization of US$1.7 billion and raising an additional US$379.5 million, driving an increase in the value of the Company’s Other Financial Assets on balance sheet.
New strategic technology collaboration with PharmEnable for AI-driven drug discovery – aim to identify new leads against a challenging "peptidergic" GPCR target.
First strategic collaboration to explore SBDD approaches beyond GPCRs with Metrion Biosciences – drug discovery collaboration to identify novel, highly specific leads for further development against an ion channel associated with neurological diseases.
US$2.5 million milestone received from Formosa Pharmaceuticals – based on progression of APP13007, a divested asset, into Phase 3 trials as a new potential treatment for pain and inflammation following cataract surgery.
Post-period Highlights

¥29.8 billion raised from International Offering of Euro-Yen denominated convertible bonds due 2026. Strong demand from international investors – largest mid-cap convertible bond raise in Asia Pacific region since 2015. The Company intends to use the proceeds as follows:
repurchase of existing convertible bonds due 2025
to finance, together with current cash, strategic growth initiatives including (1) funding acquisitions of or investments in companies or technologies including in the areas of neurology, gastroenterology, immunology and rare diseases that complement and strengthen Sosei’s existing business foundation for drug candidate discovery and early development; and (2) funding potential introduction of drug products in the Japanese domestic market.
To finance research and development of new pipeline programs and working capital.
Entered multi-target AI-powered and GPCR-focused drug discovery collaboration with InveniAI – focus on identifying novel GPCR targets for multiple immune diseases
Financial Highlights for the Six-month Period ended 30 June 2021

Revenue totalled JPY 3,123 million (US$28.9 million*), an increase of JPY 607 million (US$5.7 million) vs. the prior corresponding period. The increase was due to the achievement of five progress milestone events from existing partners vs. one upfront fee and two milestone events in the prior corresponding period. In addition, there was an increase in deferred revenue releases from existing collaboration partners. Royalties from Novartis were stable.
Cash R&D expenses totalled JPY 2,382 million (US$22.0 million), an increase of JPY 882 million (US$8.1 million) vs. the prior corresponding period. The increase in R&D spend reflects higher activity levels on in-house programs (including the recently reverted muscarinic portfolio), participation in new co-development collaborations and the impact of a stronger GBP vs. JPY. Despite the relative increase in R&D spend vs. the prior corresponding period, the current period spend is in-line with our budgeted plans, and therefore our full year forecast cash R&D expenses remain unchanged, in the range of JPY 4,000 to JPY 5,000 million.
Cash G&A expenses totalled JPY 1,256 million (US$11.6 million), an increase of JPY 331 million (US$3.1 million) vs. the prior corresponding period. The increase in G&A spend is due to an increase in personnel related expenses and professional advisory fees as the Group continued to evaluate strategic growth opportunities. In addition, personnel related expenses in the prior corresponding period were lower than normal as a result of a reduction in the U.K. share-based payment related National Insurance liability, which was driven by share price movements in that particular period. Despite the relative increase in G&A spend vs. the prior corresponding period, the current period spend is in-line with our budgeted plans, and therefore our full year forecast cash G&A expenses remain unchanged, in the range of JPY 1,800 to 2,300 million.
Cash earnings loss** totalled JPY 800 million (US$7.4 million), vs. a cash earnings loss of JPY 181 million (US$1.7 million) in the prior corresponding period. The main reason for the increase in the cash earnings loss is that the increase in Cash R&D and G&A costs exceeded the increase in revenue, largely attributable to increased R&D investment (e.g. in the muscarinic portfolio and prioritized in-house programs) and professional advisory fees, as stated above.
Operating loss totalled JPY 1,849 million (US$17.1 million) vs. an operating loss of JPY 1,136 million (US$10.5 million) in the prior corresponding period. The main reason for the increase in the operating loss is that the increase in operating expenses exceeded the increase in revenue, including a small Oravi related impairment and higher stock-based compensation costs as the Company continued to roll out Restricted Stock Unit (RSU) plans for employees to drive greater long-term alignment with shareholders. Financing costs in the period were largely offset by contingent consideration and foreign exchange gains.
Loss for the six-month period ended 30 June 2021 totalled JPY 2,297 million (US$21.2 million) vs. a loss for the prior corresponding period of JPY 2,117 million (US$19.6 million). The main reason for the increase in net loss is the increase in the operating loss (for the reasons stated above), although the impact was largely mitigated by a gain relating to our investment in MiNA Therapeutics (driven by the receipt of a US$25 million upfront fee relating to an out-license with Lilly signed in May 2021).
Cash and cash equivalents as at 30 June 2021 increased by JPY 621 million (however decreased US$19 million) from the beginning of the year and amounted to JPY 40,629 million (US$367.5 million). Modest cash inflow achieved when balances aggregated in JPY, however weaker JPY in the period drove a reduction in total cash balance when aggregated in US$.
*Convenience conversion to US$ at the following rates: 2021: 1US$ =108.11 JPY; 2020: 1US$ =108.25 JPY

**Non-IFRS measure

On August 12, 2021 Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage oncology company developing potentially first-in-class therapeutics that combine both targeted and immune-mediated mechanisms, reported financial results and provided a corporate update for the second quarter ended June 30, 2021 (Press release, Tempest Therapeutics, AUG 12, 2021, View Source [SID1234586558]).

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"The second quarter of 2021 was an exciting period as Tempest became a public company and the team drove progress in all three of our novel programs," said Steve Brady, chief executive officer of Tempest. "We look forward to the planned opening of the TPST-1120 randomized study in first line hepatocellular carcinoma in collaboration with Roche and the first combination study of TPST-1495, and remain focused on delivering potentially value-creating milestones over the next year and beyond."

Recent Highlights

Public Company Transition: successfully closed merger and concurrent PIPE financing, allowing Tempest to become a public company listed on the Nasdaq Capital Market, and extending runway into 2023 through multiple potential catalysts.
TPST-1495 (clinical dual EP2/4 prostaglandin receptor antagonist): continued enrollment in monotherapy dose optimization towards recommended Phase 2 dose ("RP2D").
TPST-1120 (clinical PPARα antagonist): (i) completed monotherapy dose escalation and selected 600mg BID as RP2D; (ii) observed stable disease ("SD") in 50% of the monotherapy-treated patients, including prolonged SD in patients with refractory cholangiocarcinoma; and (iii) observed a deep, confirmed partial response in a patient with checkpoint inhibitor-refractory fourth line renal cell carcinoma in the combination study with nivolumab (->60% by RECIST 1.1, durable through 4 scans and ongoing).
TREX-1 Inhibitor (preclinical, tumor-selective STING pathway activator): (i) progressed lead series to picomolar IC50 potency in biochemical assays; and (ii) demonstrated significant proof of concept in a mouse tumor model with systemic delivery of a lead series molecule.
Board of Directors: Christine Pellizzari, J.D., Geoff Nichol, M.B., Ch.B., M.B.A., and Ronit Simantov, M.D., joined the Board of Directors, bringing deeper financial, legal, and clinical development expertise to Tempest.
Planned Near-Term Milestones

TPST-1495 (clinical dual EP2/4 prostaglandin receptor antagonist): (i) selection of monotherapy RP2D expected in the first half of 2022; (ii) commencement of a combination study with an anti-PD-1 checkpoint inhibitor expected prior to the end of 2021; and (iii) commencement of monotherapy expansion in targeted indications and biomarker-selected patient populations expected in the first half of 2022.
TPST-1120 (clinical PPARα antagonist): (i) identification of RP2D of TPST-1120 in combination with nivolumab expected prior to the end of 2021; and (ii) commencement of first line randomized Phase 1b/2 study in hepatocellular carcinoma patients, under a collaboration with F. Hoffman La Roche, expected within the third quarter.
TREX-1 Inhibitor (preclinical tumor-selective STING pathway activator): planned selection of development candidate in the first half of 2022.
Financial Results

Second Quarter

Tempest ended the second quarter of 2021 with $68.5 million in cash and cash equivalents and short-term restricted cash, compared to $18.8 million in December 31, 2020. The increase was primarily due to the merger and concurrent PIPE, which closed in June 2021.
Net loss and net loss per share for the second quarter of 2021 were $7.1 million and $7.63, respectively, compared to $5.2 million and $11.42, respectively, for the second quarter of 2020. The increase was primarily due to an increase in compensation expense and professional fees associated with the merger.
Research and development expenses for the second quarter of 2021 were $4.2 million, compared to $4.1 million for the same period in 2020. The $0.1 million increase was primarily attributable to increased compensation expenses.
For the three months ended June 30, 2021, general and administrative expenses were $2.6 million compared to $1.1 million for the same period in 2020. The increase was primarily due to growth in compensation expense and professional fees associated with the merger.
Year-to-Date

Net cash used in operations for the six months ended June 30, 2021 was $6.2 million.
Net loss and net loss per share for the six months ended June 30, 2021 were $12.4 million and $17.30, respectively, compared to $9.5 million and $21.28, respectively, for the same period in 2020.
Research and development expenses for the six months ended June 30, 2021 were $7.8 million compared to $7.1 million for the same period in 2020. The $0.7 million increase was primarily due to increased compensation expenses and consulting services.
For the six months ended June 30, 2021, general and administrative expenses were $4.1 million compared to $2.4 million for the same period in 2020.

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 [SID1234586370]).

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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.