On May 13, 2021 Synlogic, Inc. (Nasdaq: SYBX), a clinical stage company bringing the transformative potential of synthetic biology to medicine, reported financial results for the first quarter ended March 31, 2021, and provided an update on its clinical and preclinical programs (Press release, Synlogic, MAY 13, 2021, View Source [SID1234579940]).

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"We are building momentum and executing on our plans to demonstrate the clinical potential of our Synthetic Biotic platform in 2021," said Aoife Brennan, M.B. Ch.B., Synlogic’s President and Chief Executive Officer. "With proof of mechanism established in our two lead metabolic programs and a strengthened balance sheet, we are well positioned to deliver proof of concept readouts for both SYNB1618 in Phenylketonuria (PKU) and SYNB8802 in Enteric Hyperoxaluria later this year."

Quarter Highlights

The Metabolic Portfolio:

Continued development of Synthetic Biotic medicines for the treatment of PKU.

Enrollment of the SynPheny-1 Phase 2 trial is on track with data expected in the second half of 2021. 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 such as KUVAN (sapropterin dihydrochloride) or PALYNZIQ (pegvaliase-pqpz).

Data on the solid oral formulation of SYNB1618 was presented at the American College of Medical Genetics meeting in April 2021.

Continued development of SYNB1934, an evolved Synthetic Biotic medicine in the PKU portfolio, which may provide increased Phe lowering efficacy, lower dosing, or both, relative to SYNB1618. SYNB1934 is progressing through IND enabling studies.
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.

Demonstration of proof of mechanism of SYNB8802, a Synthetic Biotic medicine being developed for the treatment of Enteric Hyperoxaluria.

In an ongoing Phase 1 study, SYNB8802 demonstrated safety and urinary oxalate lowering in healthy volunteers consuming a high oxalate diet.

Urinary oxalate lowering by SYNB8802 was dose-dependent. The 3e11 dose was chosen for further evaluation in the second part of the Phase 1 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.

The second part of the Phase 1 study is continuing with the evaluation of SYNB8802 in patients with Enteric Hyperoxaluria secondary to Roux-en-Y gastric bypass surgery. Data from the second part of the study is anticipated in the second half of 2021.
SYNB8802 is an orally administered Synthetic Biotic medicine being developed as a potential treatment for Enteric Hyperoxaluria. 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. SYNB8802 is designed to consume oxalate in the GI tract to prevent the increased absorption of oxalate in patients with Enteric Hyperoxaluria.

The Immunomodulation Portfolio:

Progression of SYNB1891 in combination arm dosing with PDL1 checkpoint inhibitor in an ongoing Phase 1 clinical 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. The maximum tolerated dose has not been reached and dose escalation continues.

Part B is a combination arm and dosing has been completed in two cohorts to date with SYNB1891 and the PD-L1 checkpoint inhibitor atezolizumab to establish a recommended Phase 2 dose for the combination regimen.

Data from this study was presented at the American Association of Cancer Research meeting in April 2021.
SYNB1891 is an intratumorally administered Synthetic Biotic medicine engineered to act as a dual innate and adaptive immune activator. Data from both arms of the Phase 1 study will continue to be reported over the course of 2021, with mature combination therapy data expected by the end of the year.

Corporate Update:

Synlogic strengthens Balance Sheet.

On April 20th, subsequent to the end of the first quarter, Synlogic completed an underwritten public offering of 11.5 million shares. Net proceeds from the offering were $32.6 million, bringing Synlogic’s cash balance to approximately $127 million.
Synlogic advances strategic partnerships and expands manufacturing capabilities.

Synlogic plans to expand its manufacturing footprint by more than 50% to support continued advancement of its pipeline and late-phase development of its lead metabolic programs.

Synlogic will invest to expand fermentation and lyophilization capacity to support scale up efforts, enabling potential late stage development of SYNB1618 and SYNB8802.

Construction and build out anticipated to take place in the second half of 2021.

Synlogic and the MIT Voigt Lab are collaborating with the Air Force Research Laboratory (AFRL) and the Department of Defense (DoD) to engineer novel investigational medicines to address battle fatigue.

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.
First Quarter 2021 Financial Results

As of March 31, 2021, Synlogic had cash, cash equivalents and short-term investments of $94.4 million.

For the three months ended March 31, 2021, Synlogic reported a consolidated net loss of $15.0 million, or $0.36 per share, compared to a consolidated net loss of $15.8 million, or $0.46 per share, for the corresponding period in 2020.

Research and development expenses were $11.2 million for the three months ended March 31, 2021 compared to $12.7 million for the corresponding period in 2020.

General and administrative expenses for the three months ended March 31, 2021 were $3.9 million compared to $3.8 million for the corresponding period in 2020.

There was no revenue for the three months ended March 31, 2021 compared to $0.1 million for the corresponding period in 2020. Revenue for the prior period was associated with Synlogic’s 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, balance sheet as of March 31st, 2021 and proceeds from the recent public offering in April 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, May 13, 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 2526209. A replay will be available for 30 days on the Investors and Media section of the Synlogic website.

On May 13, 2021 Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) ("Processa" or the "Company"), a clinical stage company developing drugs for patients who have unmet medical conditions that require better treatment options to improve a patient’s survival and/or quality of life, reported financial results for the year ended March 31, 2021, and provides corporate update (Press release, Processa Pharmaceuticals, MAY 13, 2021, View Source [SID1234579939]).

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Dr. David Young, CEO and chairman of Processa, commented, "During the first quarter we made substantial progress advancing our three clinical in-licensed drugs, each with a potential market exceeding $1 billion. We expect first patients to be dosed with PCS6422 and PCS499 within the next six weeks, and to receive interim data for PCS6422 near the end of the third quarter of 2021 and interim data for PCS499 during the first quarter of 2022."

Recent Highlights and New Developments

We have selected 5 U.S. clinical sites to enroll patients with ulcerative necrobiosis lipoidica and started the screening process for our first patient in our Phase 2B trial "A Randomized, Double-blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of PCS499 in Treating Ulcerations in Patients who Have Necrobiosis Lipoidica." In order to expedite enrollment for this rare condition, we are evaluating additional clinical sites both within and outside the U.S.

We are initiating clinical sites to enroll patients into our Phase 1B trial "A Study of the Safety and PK of PCS6422 (Eniluracil) with Capecitabine in Patients with Advanced, Refractory GI Tract Tumors."

We have received guidance from the FDA and plan to submit an IND application in the third quarter of 2021. PCS12852 is a small molecule drug in development for the treatment of gastroparesis and functional gastrointestinal motility disorders.

In February 2021, we closed a private placement with institutional and accredited investors for gross proceeds of $10.2 million. We sold 1,321,132 shares of the common stock at a purchase price of $7.75 per share and received net proceeds of $9.9 million.

Upcoming Clinical Drug Development Milestones

First half of 2021

Dose our first patient in our PCS499 (Ulcerative NL) Phase 2B trial.
Dose our first patient in our PCS6422 (cancer) Phase 1B trial.
Second half of 2021

Submit our IND application for PCS12852 in Gastroparesis to FDA.
Begin our interim cohort results for PCS6422.
First half of 2022

• Obtain interim results from our PCS499 Phase 2B trial.
• Dose our first patient in a Phase 2A trial for PCS12852.

Financial Results for the first quarter of 2021

Our cash and cash equivalents totaled $23 million as of March 31, 2021, compared to $15.4 million as of December 31, 2020. We had 15.5 million shares of common stock outstanding as of March 31, 2021.

Our research and development expenses for the three months ended March 31, 2021 were $1.5 million compared to $501 thousand for the three months ended March 31, 2020. General and administrative expenses for the three months ended March 31, 2021 were $717 thousand compared to $484 thousand for the three months ended March 31, 2020. We reported a net loss for the three months ended March 31, 2021 of $2.1 million compared to a net loss for the comparable prior year period of $874 thousand. Our net loss per share for the three months ended March 31, 2021 was $0.14 compared to net loss per share for the three months ended March 31, 2020 of $0.16.

Conference Call Information

To participate in this event, please dial in approximately 5 to 10 minutes before the beginning of the call.

On May 13, 2021 Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (INTASYL) therapeutic platform, reported its financial results for the quarter ended March 31, 2021 and provided a business update (Press release, Phio Pharmaceuticals, MAY 13, 2021, View Source [SID1234579938]).

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"This year has started out with great momentum across our pipeline, as we continue to present a steady flow of positive data that further demonstrate the value of direct therapy with INTASYL compounds, as well as their application in improving the efficacy of cell-based immunotherapy products. Results from various animal studies, including data presented at the AACR (Free AACR Whitepaper) conference last month, show how INTASYL compounds directly delivered to the tumor can activate the immune response resulting in strong anti-tumor effects. We also presented additional compelling data showing improvements of T cell immunotherapy products by reprogramming them with INTASYL compounds, and their resulting increased in vivo efficacy. For example, at the ASGCT (Free ASGCT Whitepaper) conference this week, we announced data showing how PH-762 can unlock the potential of CAR-T cell therapy in solid tumors. These data provide proof-of-concept for the application of PH-762 mediated PD-1 checkpoint silencing in CAR-T cells prior to adoptive cell therapy to enhance the therapeutic efficacy of CAR-T cell therapy. This is tremendous data for our program, especially when considering a recently published clinical study showing that similar strategies using CRISPR-Cas9 mediated PD-1 disruption in T cells is much less efficient," said Dr. Gerrit Dispersyn, President and CEO of Phio.

"As a result of the overwhelmingly positive data we’ve collected across our pipeline, we have moved to initiate a clinical study using intra-tumoral administration of PH-762 in patients with advanced melanoma, which is expected to begin in the fourth quarter of 2021. The clinical trial will be conducted at the Gustave Roussy Institute, which is one of the leading anti-cancer centers in Europe, with Dr. Caroline Robert as our lead principal investigator. This is an exciting next step in the development of innovative therapeutics based on our INTASYL platform and we look forward to keeping you posted as we move closer towards initiation of the study," concluded Dr. Dispersyn.

Quarter in Review and Recent Corporate Updates

Presented positive data from a study assessing the potential of PH-762, a PD-1 targeting INTASYL compound, to enhance the therapeutic efficacy of HER2-targeted CAR-T cells (HER2CART) in solid tumors, namely a subcutaneous HER2-expressing SKOV3 model of human ovarian cancer in mice. Compared to untreated HER2CART cells, HER2CART cells treated with PH-762 showed a statistically significant and durable inhibition of in vivo tumor growth. These data were included in a poster presentation during the 24th Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper).
Announced new in vivo data showing intratumoral (IT) treatment with PD-1 targeting INTASYL (mPH-762) inhibits tumor growth in a dose dependent fashion in both PD-1 responsive and refractory models. These data were included in a poster presentation during the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021.
Further bolstered the balance sheet to a total of $32.7 million in cash, following the completion of two financings in Q1 2021 for gross proceeds of $21.7 million in additional capital.
Completed a $7.7 million registered direct offering of common stock priced at-the-market.
Completed a $14.0 million private placement of common stock and warrants priced at-the-market.
Upcoming Pipeline Milestones for 2021

Scheduled to present new in-vivo data regarding dual targeting INTASYL drug therapy (BRD4 and PD-1) at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.
Initiate a first-in-human clinical study on the use of PH-762 in adoptive cell therapy with tumor infiltrating lymphocytes in patients with metastatic melanoma or squamous cell carcinoma of the head and neck (SSCHN).
Initiate a first-in-human clinical study on the use of PH-762 direct drug therapy (intratumoral injection) in patients with advanced melanoma.
Additional data publications on the Company’s pipeline programs.
Financial Results

Cash Position

At March 31, 2021, the Company had cash of $32.7 million as compared with $14.2 million at December 31, 2020. The Company expects its current cash will be sufficient to fund currently planned operations to the second quarter of 2023.

Research and Development Expenses

Research and development expenses were approximately $2.6 million for the quarter ended March 31, 2021, compared to approximately $1.2 million for the quarter ended March 31, 2020. The increase is primarily due to manufacturing costs and fees for the required preclinical studies in support of the Company’s planned clinical trials for PH-762 as compared to the same period in the prior year.

General and Administrative Expenses

General and administrative expenses were approximately $1.0 million for the quarter ended March 31, 2021, compared to approximately $1.1 million for the quarter ended March 31, 2020. The decrease is primarily due to a decrease in legal fees as compared to the same period in the prior year.

Net Loss

Net loss was $3.4 million, or $0.32 per share, for the quarter ended March 31, 2021, compared with $2.4 million, or $1.33 per share, for the quarter ended March 31, 2020. The increase in net loss was primarily attributable to the increase in research and development expenses, as described above. The change in net loss per share was primarily due to an increase in the number of shares outstanding as a result of the Company’s capital raise activities as compared to the prior year period.

On May 13, 2021 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a leading clinical-stage precision oncology company enabled by its proprietary synthetic lethality approach to the discovery and development of novel therapeutics, reported financial results for the first quarter ended March 31, 2021 (Press release, Repare Therapeutics, MAY 13, 2021, View Source [SID1234579937]).

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"We have advanced the Phase 1/2 clinical development of our ATR inhibitor RP-3500, with initial results expected from the monotherapy arm of the trial in the second half of 2021. The PARP inhibitor and RP-3500 combination arm is now recruiting," said Lloyd M. Segal, President and Chief Executive Officer of Repare. "We are pleased that the first patient has been dosed in our Phase 1 clinical trial of RP-6306, materially ahead of the timeline we disclosed at the time of our IPO last June."

First Quarter 2021 Review and Operational Updates:

Highlighted program progress and introduced PKMYT1 as synthetic-lethal target to CCNE1 and FBXW7 at RP-6306 Virtual Investor Day Event.
In April 2021, the Company highlighted pre-clinical anti-tumor activity of RP-6306, a potential first-in-class small molecule product candidate targeting PKMYT1, which is synthetic lethal with CCNE1 amplification, FBXW7 loss, and potentially other genomic alterations.
Announced enrollment of first patient in RP-6306 Phase 1 clinical trial.
In April 2021, the Company dosed the first patient in its Phase 1 clinical trial of RP-6306.
The trial (NCT04855656) is expected to enroll approximately 60 patients with recurrent tumors characterized by genomic alterations predicted by the Company’s SNIPRx CRISPR-based platform to be sensitive to RP-6306.
The trial objectives include assessment of safety, tolerability, dose and schedule (including the establishment of a recommended Phase 2 dose).
Subject to completion and review of the Phase 1 clinical trial, the Company expects to advance RP-6306, both as monotherapy and in combination with chemotherapies and other agents, into proof-of-concept trials in 2022 targeting a variety of patient populations, including those with tumors with CCNE1 amplification, FBXW7 loss or other undisclosed alterations identified through its proprietary STEP2 screen.
Prospective enrichment of patient trial populations will be guided by the Company’s ongoing efforts to develop patient selection, target engagement and functional biomarkers.
Initiated patient recruitment of PARP-inhibitor combination arm of the RP-3500 TRESR Phase 1/2 clinical trial.
Repare has activated 10 clinical trial sites across North America and Europe, and is actively recruiting patients to evaluate RP-3500 in a combination arm with Pfizer’s PARP inhibitor, talazoparib, in addition to a monotherapy arm.
Initial results are expected to be reported from the monotherapy arm of the trial in the second half of 2021.
First Quarter 2021 Financial Results:

Cash and cash equivalents, restricted cash and marketable securities: Cash and cash equivalents, restricted cash and marketable securities as of March 31, 2021 were $319.1 million.
Research and development expenses, net of tax credits (Net R&D): Net R&D expenses were $16.5 million and $8.6 million for the quarters ended March 31, 2021 and 2020, respectively. The increase in R&D expenses year-over-year was primarily due to increases in development costs related to the Company’s RP-3500 and RP-6306 programs, as well as increases in personnel related expenses, including stock-based compensation, and certain other R&D expenses.
General and administrative (G&A) expenses: G&A expenses were $5.2 million and $2.2 million for the quarters ended March 31, 2021 and 2020, respectively. The increase in G&A expenses year-over-year was due to increases in personnel related costs, including stock-based compensation, and D&O insurance which increased as a result of the Company’s transition to a public company.
Net loss: Net loss was $21.4 million, or $0.58 per share in the quarter ended March 31, 2021 and $12.6 million, or $7.71 per share, in the quarter ended March 31, 2020.
About Repare Therapeutics’ SNIPRx Platform

Repare’s SNIPRx platform is a genome-wide CRISPR-based screening approach that utilizes proprietary isogenic cell lines to identify novel and known synthetic lethal gene pairs and the corresponding patients who are most likely to benefit from the Company’s therapies based on the genetic profile of their tumors. Repare’s platform enables the development of precision therapeutics in patients whose tumors contain one or more genomic alterations identified by SNIPRx screening, in order to selectively target those tumors in patients most likely to achieve clinical benefit from resulting product candidates.

On May 13, 2021 Monopar Therapeutics Inc. (Monopar or the Company) (Nasdaq: MNPR), a clinical-stage biopharmaceutical company primarily focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, reported first quarter 2021 financial results and recent business updates (Press release, Monopar Therapeutics, MAY 13, 2021, View Source [SID1234579936]).

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Recent Business Updates

Validive

Monopar’s Phase 2b/3 VOICE clinical trial of Validive (clonidine HCl mucobuccal tablet) for the prevention of severe oral mucositis (SOM) in patients undergoing chemoradiotherapy (CRT) for oropharyngeal cancer (OPC) dosed its first patient in February 2021 and is actively recruiting patients and initiating additional clinical trial sites. There is no FDA-approved prevention or treatment for CRT-induced SOM.
The U.S. Patent and Trademark Office (USPTO) allowed a new patent with claims for Validive covering "Clonidine and/or clonidine derivatives for use in the prevention and/or treatment of adverse side effects of chemotherapy." This patent expands coverage on the potential uses of Validive in cancer patients beyond earlier allowed claims limited specifically to the prevention and/or treatment of oral mucositis in patients receiving CRT.
Camsirubicin and Novel Analogs

Based on the Company’s current inability to gain regulatory approval to initiate the camsirubicin Phase 2 clinical trial in Spain, Monopar is evaluating alternatives to move the dose escalation run-in clinical trial forward outside of Spain. Monopar believes that it will be able to initiate the run-in clinical trial in the second half of 2021 in the U.S. or another country.

The USPTO allowed a new patent with claims covering compositions of matter for a novel family of camsirubicin analogs (2-pyrrilino camsirubicins). This patent expires in 2038, not including any patent term extensions. The patent broadens Monopar’s camsirubicin portfolio and covers a pipeline of compounds designed to retain the potentially favorable non-cardiotoxic chemical backbone of camsirubicin along with the potent broad-spectrum antitumor activity of doxorubicin. Preclinical evidence suggests that this new family of 2-pyrrilino camsirubicin analogs could be active against doxorubicin-resistant tumor cells and thereby may enable use in cancer types beyond those treatable with doxorubicin.
MNPR-101 and Related Compounds

Progress continues in the Monopar/NorthStar Medical Radioisotopes collaboration focused on developing a novel treatment for severe COVID-19 by partnering with (1) IsoTherapeutics Group, LLC to develop, optimize and manufacture humanized urokinase plasminogen activator receptor radioimmunotherapeutics (uPRITs), (2) Aragen Bioscience, Inc. which performed studies to enable the selection of a lead candidate uPRIT along with back-up candidates to potentially advance into IND-enabling development, and (3) The University of Texas Health Science Center at Tyler and its Texas Lung Injury Institute (TLII) to perform in vitro and in vivo studies and to participate in the potential clinical development of uPRITs.
A peer-reviewed preclinical study that reported the potential utility of MNPR-101 conjugates as uPAR imaging agents to improve surgical outcomes in bladder cancer and for surveillance post-resection was published in The European Journal of Cancer. This publication builds on previous studies using conjugates of MNPR-101 and its mouse analog, ATN-658, for the optical imaging of oral and colon cancer.
A peer-reviewed study titled "Engineered Antibody Fragment against the Urokinase Plasminogen Activator for Fast Delineation of Triple-Negative Breast Cancer by Positron Emission Tomography" demonstrated the potential to identify breast cancers with urokinase plasminogen activator (uPA) overexpression, and monitor uPA expression during treatment using positron emission tomography (PET) imaging along with the Company’s uPA antibody fragment radiotracer.
Results for the First Quarter Ended March 31, 2021 Compared to the First Quarter Ended March 31, 2020

Cash and Net Loss

Cash and cash equivalents as of March 31, 2021 were $25.7 million. Monopar anticipates that its current cash and cash equivalents, which includes $10.9 million of net proceeds raised in the first quarter of 2021 under the Company’s Capital on DemandTM Sales Agreement with JonesTrading Institutional Services, at an average gross price per share of $10.20, will fund the Company’s major programs at least through June 2022, including: funding and completing the Phase 2b portion of the VOICE clinical trial and commencing of the Phase 3 portion; funding the camsirubicin run-in clinical trial; continuing advancement of the COVID-19 uPRIT program; and developing other MNPR-101 related compounds and technologies. The Company plans to raise additional funds and/or engage a partner within the next 12 months to complete the VOICE clinical program and continue the camsirubicin clinical development beyond the run-in clinical trial.

Net loss for the first quarter of 2021 was $1.9 million or $0.16 per share compared to net loss of $1.1 million or $0.10 per share for the first quarter of 2020.

Research and Development (R&D) Expenses

R&D expenses for the first quarter of 2021 were $1.2 million compared to $0.3 million for the first quarter of 2020. This increase of $0.9 million was primarily attributed to increases of (1) $0.3 million for the planning of the GEIS-sponsored camsirubicin Phase 2 clinical trial including drug product manufacturing, (2) $0.3 million for R&D personnel expenses, (3) $0.2 million for the VOICE clinical trial and manufacturing-related expenses, and (4) $0.1 million for other R&D operating expenses.

General and Administrative (G&A) Expenses

G&A expenses for the first quarter of 2021 were $0.7 million, a nominal decrease from $0.8 million of G&A expenses for the first quarter of 2020.