On November 15, 2021 Athersys, Inc. (NASDAQ: ATHX) reported its financial results for the three months ended September 30, 2021 and provided a corporate update (Press release, Athersys, NOV 15, 2021, View Source [SID1234595602]).

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"The third quarter brought several important milestones in the development and potential commercialization of MultiStem cell therapy," stated Mr. William (B.J.) Lehmann, Jr., Interim Chief Executive Officer of Athersys. "First, our partner Healios announced positive topline data from its ONE-BRIDGE acute respiratory distress syndrome (ARDS) study, giving us further confidence in the potential of our cell therapy for the treatment of ARDS and critical care more generally. Second, enrollment has been completed for the Japan TREASURE study of MultiStem treatment for ischemic stroke patients, starting the countdown to the release of pivotal study data in this area. And third, we realigned our collaboration with Healios to put us in the best position to prepare together for commercialization in Japan.

"Additionally, we demonstrated steady progress in our MASTERS-2 study as well as in the steps necessary to establish commercial manufacturing capability," added Mr. Lehmann. "We look forward to important data readouts ahead of us, our partner’s progress in Japan in the application process for marketing approval, and further development of our commercial capabilities."

Highlights of the third quarter of 2021 and recent events include:

Positive topline results from the ONE-BRIDGE study announced by HEALIOS K.K. (Healios). The ONE-BRIDGE study evaluated the Company’s proprietary cell therapy, MultiStem (HLCM051; invimestrocel), for the treatment of pneumonia-induced and COVID-induced acute respiratory distress syndrome (ARDS) in Japan. Data from the study are consistent with the Company’s MUST-ARDS study results, and analyses of the pooled data of both studies reflect positive benefit trends;
Completion of TREASURE study enrollment announced by Healios. The TREASURE study is evaluating MultiStem for the treatment of ischemic stroke patients in Japan. Based on the advice from the Pharmaceuticals and Medical Devices Agency (PMDA), in order to avoid any potential bias to the 365-day data (and related secondary endpoints) that could result from unblinding and disclosure of 90-day data (primary endpoint) the decision was made that the 90-day unblinding, data analysis and release would take place after the 365-day data is locked. This will follow the last patient’s one-year follow up visit which Healios expects to occur in March of 2022;
Improved our collaboration with Healios and optimized the structure of the relationship to help drive commercial success for MultiStem therapy in Japan;
Steadily progressed our MASTERS-2 study, including the initiation of new sites, including our first sites outside of the U.S.;
Published additional important research findings covering Multipotent Adult Progenitor Cells (MAPC) and Treg biology and MAPC mechanisms of action, with references available on the Company’s website;
Achieved a "Prime" corporate rating from Institutional Shareholder Services Environmental, Social and Governance (ISS ESG) for fulfilling the requirements regarding sustainability performance in the Pharmaceuticals & Biotechnology sector;
Recognized net loss of $16.2 million, or $0.07 net loss per share, for the quarter ended September 30, 2021; and
Ended the third quarter with $49.7 million of cash and cash equivalents.
Third Quarter Results

Revenues increased to $4.8 million for the three months ended September 30, 2021 compared to $0.1 million for the three months ended September 30, 2020. Our collaboration revenues currently fluctuate from period to period based on the delivery of goods and services under our arrangement with Healios.

Research and development expenses decreased to $17.2 million for the three months ended September 30, 2021 from $18.5 million for the comparable period in 2020. The $1.3 million decrease is associated with decreases in clinical trial and manufacturing process development costs of $2.0 million and internal research supplies of $0.6 million. These decreases were partially offset by increases in personnel costs of $0.5 million, facilities costs of $0.4 million and outside service costs of $0.4 million. Our clinical development, clinical manufacturing and manufacturing process development expenses vary over time based on the timing and stage of clinical trials underway, manufacturing campaigns for clinical trials and manufacturing process development projects.

General and administrative expenses decreased to $3.6 million for the three months ended September 30, 2021 from $3.7 million for the comparable period in 2020.

Net loss for the third quarter of 2021 was $16.2 million compared to a net loss of $22.5 million in the third quarter of 2020. The difference primarily results from the above variances.

During the nine months ended September 30, 2021, net cash used in operating activities was $56.9 million compared to $44.5 million in the nine months ended September 30, 2020. At September 30, 2021, we had $49.7 million in cash and cash equivalents, compared to $51.5 million at December 31, 2020.

Conference Call

We encourage shareholders to listen using the webcast link above. If you would like to dial in using the phone to ask a question, please register for the conference call ahead of time using the call registration link above. Once registered, you will receive the toll-free number, a direct entry passcode and a registrant ID.

A replay of the event will be available on the webcast link at www.athersys.com under the investors’ section approximately two hours after the call has ended. Shareholders may also call in for on-demand listening approximately three hours after the completion of the call until 11:59 PM EST on November 22, 2021, by dialing (800) 585-8367 or (416) 621-4642 and entering the conference code 6652068.

On November 15, 2021 Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, reported that Lawrence M. Blatt, Ph.D., MBA, Chairman and CEO of Aligos, will present at the Jefferies London Healthcare Conference and participate in virtual investor 1×1 meetings on the November 18-19, 2021 (Press release, Aligos Therapeutics, NOV 15, 2021, View Source [SID1234595601]).

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A webcast of the presentation will be available starting November 18, 2021, 8:00 AM GMT / 3:00 AM ET on the events section of the Aligos Website or by clicking the following link: Webcast Registration. A replay will be available following the presentation for 30-days.

Please contact your Jefferies representative to schedule virtual one-on-one meetings with Aligos during the conference. For more information about the Jefferies London Healthcare Conference, please refer to the Jefferies Conference Website.

On November 15, 2021 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported its financial results for the third quarter ended September 30, 2021 (Press release, Syndax, NOV 15, 2021, View Source [SID1234595600]). In addition, the Company provided a clinical and business update.

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"We are thrilled to announce that the pivotal Phase 2 portion of AUGMENT-101, examining SNDX-5613 across three distinct patient populations, is open and enrolling following a productive meeting with the U.S. Food and Drug Administration (FDA)," said Briggs W. Morrison, M.D., Chief Executive Officer of Syndax. "Supported by a growing body of data, we firmly believe that SNDX-5613 is ideally positioned to be first to market and serve as a meaningful intervention for patients with mutant nucleophosmin (NPM1c) and mixed lineage leukemia rearranged (MLLr) acute leukemias who are deeply in need of effective therapies. We look forward to presenting updated data from the Phase 1 portion of the AUGMENT-101 trial, including updated durability of CR/CRh responses, during an oral session at the upcoming 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting."

"We were also pleased to recently announce our partnership with Incyte for the development and commercialization of axatilimab. This agreement represents a key step forward in our strategy to expand and maximize the program across multiple lines of treatment in chronic graft-versus-host disease (cGVHD) as well as additional fibrotic diseases, such as idiopathic pulmonary fibrosis (IPF), where the monocyte-macrophage lineage plays a vital role. As we continue to execute on advancing the program, we look forward to sharing updated data from our Phase 1/2 trial of axatilimab in cGVHD during an oral session at the ASH (Free ASH Whitepaper) Annual Meeting next month."

Recent Pipeline Progress and Anticipated Milestones

SNDX-5613

The Phase 2 portion of AUGMENT-101 is currently enrolling patients with NPM1c mutant and MLLr relapsed/refractory (R/R) acute leukemias. A total of 64 adult and up to 10 pediatric patients will be enrolled across each of the following three distinct trial populations: patients with NPM1 mutant acute myeloid leukemia (AML), patients with MLLr AML, and patients with MLLr acute lymphocytic leukemia. Discussions with the FDA have confirmed that AUGMENT-101 may potentially serve as the basis for regulatory filings in each of the three distinct trials. The primary endpoint for each of the three trials will be efficacy as measured by complete remission rate (complete response [CR] + CR with partial hematologic recovery rate [CRh]), with key secondary endpoints including duration of response and overall survival.
In November 2021, the Company announced that updated data from the Phase 1 portion of the ongoing AUGMENT-101 trial will be featured during an oral session at the 63rd ASH (Free ASH Whitepaper) Annual Meeting being held December 11-14, 2021. Data included in the abstract demonstrated robust clinical activity with durable responses and no discontinuations due to treatment-related adverse events. The oral presentation will include updated Phase 1 data from additional patients as of a more recent cutoff date, as well as further details on durability and CR/CRh rate by mutational status.
The Company reported plans to initiate a new trial to assess the anti-leukemic efficacy of SNDX-5613 in NPM1 or MLLr patients with measurable residual disease (MRD) progression following initial treatment. The trial will be conducted as part of the Australian Leukemia and Lymphoma Group (ALLG) INTERCEPT Master Clinical Trial, a collaborative clinical trial investigating novel therapies to target early relapse and clonal evolution as pre-emptive therapy in AML. SNDX-5613 is the first menin inhibitor to be included in the INTERCEPT AML Master Clinical Trial. The Company expects ALLG to initiate the trial in the first half of 2022.
In August 2021, the Company announced plans to initiate two additional trials to assess the safety, tolerability, and preliminary anti-leukemic efficacy of SNDX-5613 in combination with venetoclax and azacitidine as part of the Leukemia & Lymphoma Society’s Beat AML Master Clinical Trial, and in combination with chemotherapy in patients with R/R NPM1 or MLLr acute leukemias in the AUGMENT-102 trial. The Company expects both trials to initiate in the first half of 2022.
Axatilimab

In November 2021, the Company announced that updated data from its Phase 1/2 trial of axatilimab in patients with cGVHD will be featured during an oral session at the 63rd ASH (Free ASH Whitepaper) Annual Meeting. Data included in the abstract demonstrated broad efficacy and tolerability for axatilimab in patients with relapsed or refractory cGVHD. The oral presentation will include additional follow up on all patients enrolled.
Enrollment is ongoing in the Company’s global pivotal Phase 2 AGAVE-201 trial of axatilimab in patients with cGVHD, with topline data expected in 2023. The trial will evaluate the safety and efficacy of three doses and schedules of axatilimab. The primary endpoint will assess objective response rate based on the 2014 NIH consensus criteria for cGVHD, with key secondary endpoints including duration of response and improvement in modified Lee Symptom Scale score.
In September 2021, Syndax and Incyte announced that they entered into an exclusive worldwide collaboration and license agreement to develop and commercialize axatilimab. Syndax and Incyte are seeking to develop axatilimab as a backbone therapy for patients with cGVHD as well as in additional immune-mediated diseases where CSF-1R-dependent monocytes and macrophages are believed to contribute to organ fibrosis. In addition to the ongoing global pivotal Phase 2 AGAVE-201 trial of axatilimab monotherapy in patients with cGVHD, the companies also plan to initiate additional trials of axatilimab in patients with cGVHD in 2022, including a Phase 2 trial in combination with a JAK inhibitor in patients with steroid-refractory cGVHD. Beyond cGVHD, Syndax plans to commence a Phase 2 proof of concept trial of axatilimab mid next year in patients with IPF, a serious, life-limiting orphan disease for which axatilimab may represent a much-needed treatment option with a novel mechanism of action.
Corporate Updates

In September 2021, Syndax announced the expansion of its Board of Directors to nine members with the appointment of Martin H. Huber, M.D. Dr. Huber has over 20 years of academic, biotechnology, and pharmaceutical drug development experience, currently serving as the President of Research and Development (R&D) and Chief Medical Officer of Xilio Therapeutics, Inc.
Third Quarter 2021 Financial Results

As of September 30, 2021, Syndax had cash, cash equivalents and short-term investments of $229.7 million and 52.2 million shares and share equivalents issued and outstanding. This includes 3.3 million pre-funded warrants.

Third quarter 2021 R&D expenses increased to $25.6 million from $14.4 million for the prior year period. The increase was primarily due to increased clinical trial activities and CMC activities for both SNDX-5613 and axatilimab.

General and administrative expenses for the third quarter 2021 increased to $6.8 million from $5.8 million for the prior year period. The increase is primarily due to increased professional fees.

For the three months ended September 30, 2021, Syndax reported a net loss attributable to common stockholders of $20.6 million or $0.40 per share compared to $20.4 million or $0.46 per share for the prior year period.

Financial Update and Guidance

For the full year of 2021, R&D expenses are expected to be $90 to $100 million, and total operating expenses are expected to be $110 to $120 million.

Conference Call and Webcast

In connection with the earnings release, Syndax’s management team will host a conference call and live audio webcast at 4:30 p.m. ET today, Monday, November 15, 2021.

The live audio webcast and accompanying slides may be accessed through the Events & Presentations page in the Investors section of the Company’s website at www.syndax.com. Alternatively, the conference call may be accessed through the following:

For those unable to participate in the conference call or webcast, a replay will be available on the Investors section of the Company’s website, www.syndax.com.

On November 15, 2021 iBio, Inc. (NYSEA:IBIO) ("iBio" or the "Company"), a developer of next-generation biopharmaceuticals and pioneer of the sustainable FastPharming Manufacturing System, reported its financial results for the fiscal quarter ended September 30, 2021 and provides a corporate update (Press release, iBioPharma, NOV 15, 2021, View Source [SID1234595599]).

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"We are continuing to accelerate the execution of our growth strategy as we start our fiscal year 2022," said Tom Isett, Chairman & CEO of iBio. "Having only just launched our oncology initiative six months ago, we have already created six active programs, including the two new ones announced today. In addition, we have advanced our novel COVID-19 vaccine candidate to pre-IND, while concurrently building out our vaccine platform with new drug delivery technology partnerships. We have also acquired our cGMP manufacturing facility and taken sole ownership of our CDMO subsidiary, along with the attendant rights to manufacture biologics using our FastPharming System in the United States. We are confident that our investments over the past year in talent, technology, and infrastructure will return value to patients and shareholders as we go forward."

Fiscal First Quarter and Recent Business Developments:

BIOPHARMACEUTICALS

Therapeutics

In August 2021, iBio added to its pipeline by in-licensing an IL-2 sparing anti-CD25 antibody (IBIO-101) from RubrYc Therapeutics. Pre-clinical data shows that the molecule can deplete regulatory T cells from the tumor microenvironment and restore anti-tumor immunity, potentially representing an important new tool in the fight against cancer.
The Company continues to advance its endostatin E4 molecule for fibrotic diseases (IBIO-100) toward the clinic. Meanwhile, leveraging its investment in endostatin E4, iBio announced earlier today that it will separately explore the molecule’s usefulness in the treatment of solid tumors as part of a research collaboration with the University of Texas Southwestern Medical Center.
Pursuant to its new partnership with RubrYc Therapeutics wherein artificial intelligence ("AI")-based antibody discovery technologies are deployed, iBio announces today that the first new target is now being optimized using the platform. This result follows just two months after the joint discovery collaboration was initiated.
Vaccines

The Company recently conducted a preclinical dose ranging study of IBIO-202, its nucleocapsid ("N") antigen-based, intramuscularly ("IM")-delivered COVID-19 vaccine candidate. The results confirmed generation of a robust, antigen-specific, memory T-cell response and provided data that further informed iBio’s product formulation strategy.
The Company submitted a pre-IND package for IBIO-202 to the U.S. Food and Drug Administration in September 2021 and is anticipating a response in the coming months.
Today, iBio announces that is has entered a collaboration with a leading innovator of microarray patch systems, which are a painless alternative to IM injections. The first objective of the collaboration is to evaluate feasibility of intradermal delivery of a COVID-19 vaccine antigen. If successful, the partnership has the potential to drive improved access to vaccines by avoiding cold chain issues and possibly enabling self-administration. The collaboration is not expected to impact the current development timeline of IBIO-202.
The Company continues to advance its Classical Swine Fever ("CSF") vaccine candidate, IBIO-400, through the U.S. Department of Agriculture’s Centers for Veterinary Biologics’ regulatory process. Additionally, iBio announces today that studies are now underway at Texas A&M University System to evaluate alternatives to IM injection of its CSF vaccine candidate, including an oral dose option.
BIOPROCESS

In November 2021, iBio purchased the Bryan, Texas, manufacturing facility it previously operated under a lease from two affiliates of Eastern Capital Limited (the "Eastern Affiliates"). The Company also acquired the equity interest in iBio CDMO, LLC, that was formerly held by the Eastern Affiliates. As a result, the subsidiary and its intellectual property are now wholly-owned by iBio.
Fiscal First Quarter and Recent Corporate Developments:

iBio made progress in government relations during the quarter by engaging with senior-level U.S. policymakers to build awareness of the FastPharming System and to underscore the benefits of rapid, sustainable, domestic bioproduction.
iBio is encouraging shareholders who held common stock at the close of business on October 15, 2021 to vote "FOR" all proposals put forth in the proxy statement prior to its December 9, 2021, Annual Meeting of Stockholders to help the Company continue to grow its pipeline, services, and value.
"Over the course of the next year, we are focused on delivering shareholder value across multiple fronts, including announcing new oncology targets and two possible IND filings," said Mr. Isett. "We are also excited about the partnership opportunities that we see ahead for our bioprocess business as industry awareness of the need to implement sustainable, ESG-based practices continues to grow. With sole ownership of our FastPharming Facility and CDMO subsidiary now secured, we have additional strategic and operational flexibility to deploy our rapid, scalable biologics development system for our own pipeline, as well as for clients, so that we may enable more potentially life-saving therapeutics to enter the clinic."

Financial Results:

Revenues for the first fiscal quarter ended September 30, 2021, were approximately $211,000, a decrease of 49% from approximately $410,000 in the same period of 2020. As noted previously, significant quarter-to-quarter revenue variability is commonplace for early-stage pharma services companies given the timing of revenue recognition. Consistent with these business dynamics, iBio continues to expect a sequential decline in revenue during the first half of fiscal 2022 compared to the second half of fiscal 2021, followed by higher growth in the second half of fiscal 2022.

R&D and G&A expenses for the first quarter of fiscal 2022 increased 35% and 24%, respectively, over the comparable period in fiscal 2020. This reflects the Company’s growing investments in its pipeline, platform technologies, employees, and related infrastructure. iBio anticipates this trend continuing, however, the rate of growth is expected to moderate over time.

iBio’s consolidated net loss for the first quarter ended September 30, 2021, was approximately $8.9 million, or $0.04 per share, compared to a net loss of approximately $7.5 million, or $0.05 per share, in the same period of 2020.

iBio had $82.3 million dollars in cash and cash equivalents and investments in debt securities as of September 30, 2021. The Company used $9.3 million in cash during the quarter for operating activities and $5.1M for investing activities which included elements of the RubrYc transaction and for capital expenditures. Subsequent to the end of the first quarter of fiscal 2021, iBio used approximately $6.0 million in cash to help fund the purchase of its manufacturing facility in Bryan, Texas, and to secure full control of iBio CDMO, LLC, which holds the exclusive rights to manufacture using the FastPharming System in the United States. Taking into account potential long-term financing options, combined with the approximate 67% savings in facility-related cash requirements expected to be achieved through this transaction, the Company continues to believe that its current cash position is sufficient to fund its operations through Q3-FY23. If the Company cannot take advantage of the additional financial flexibility, and based on the Company’s working capital on September 30, 2021, management has concluded that there is sufficient liquidity to fund normal operations through at least Q2-FY23.

Webcast and Conference Call

iBio management will host a webcast and conference call at 4:30 p.m. Eastern Time today, November 15, 2021, to discuss these results and provide a corporate update.

The live and archived webcast may be accessed on the Company’s website at www.ibioinc.com under "News and Events" in the Investors section. The live call can be accessed by dialing (833) 672-0651 (domestic) or (929) 517-0227 (international) and referencing conference code: 7779281.

On November 15, 2021 TransCode Therapeutics, Inc. (Nasdaq: RNAZ), an RNA oncology company created on the belief that cancer can be defeated through the intelligent design and effective delivery of RNA therapeutics, reported recent business progress and third quarter 2021 financial results (Press release, TransCode Therapeutics, NOV 15, 2021, View Source [SID1234595598]).

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"TransCode has made further progress across our corporate infrastructure and bourgeoning portfolio, advancing our mission to design RNA therapeutics that can effectively treat cancer. Reflecting the results of an important microdosing study recently reported in Cancer Nanotechnology, TransCode believes it has an opportunity in its planned First-in-Human (FIH) Phase 0 clinical trial of its lead therapeutic candidate, TTM-MC138, to obtain results that will better inform designs of planned follow-on trials than the original FIH trial design. The reported study was conducted by Dr. Zdravka Medarova, a scientific co-founder of TransCode Therapeutics who was appointed Chief Technology Officer effective October 1," said Michael Dudley, co-founder, president and CEO of TransCode Therapeutics. Dr. Medarova noted, "We believe a microdosing study offers the potential to more definitively establish proof-of-mechanism for our delivery platform, upon which we hope to build a broad and diverse pipeline of therapeutics and diagnostics with the potential to reach previously undruggable genetic targets."

Dudley added, "We are striving to file our exploratory Investigational New Drug Application (eIND) required for the FIH trial by the end of the first quarter 2022, although because of COVID-19-related backlogs at contract research organizations, the filing may be later in the first half. Regardless, we believe the proposed microdosing study should, if successful, demonstrate the power and versatility of our TTX platform in solving the challenges of RNA delivery in oncology. In addition, we have continued IND-enabling work for TTX-MC138 and remain on track to file an IND for a Phase I clinical trial for treatment of metastatic disease by year end 2022."

Third Quarter 2021 and Recent Highlights

Expanded the Company’s executive team with the appointment of TransCode’s scientific co-founder, Zdravka Medarova, Ph.D., as Chief Technology Officer effective October 1. Dr. Medarova is a leader in the field of non-coding RNA delivery to cancer and has authored multiple high-impact publications on the topic of RNA delivery, nanotechnology, and the biology of cancer metastasis.
Continued eIND-enabling activities for TTX-MC138, the Company’s lead program, targeting micoRNA-10b (miR-10b) for treatment of metastatic solid tumors. Due to continued COVID-19-related backlogs at contract research organizations, the planned eIND filing may be in the second quarter 2022. Concurrently, IND-enabling efforts remain on track to support an IND expected to be filed in 2H 2022 for a planned Phase 1 study of TTX-MC138.
Announced publication of preclinical results supporting TTX-MC138 in Cancer Nanotechnology, based on research conducted at the Athinoula A. Martinos Center for Biomedical Imaging in the Department of Radiology at Massachusetts General Hospital and Harvard Medical School. The key results of the study demonstrated that a radiolabeled derivative of TTX-MC138, when injected intravenously, accumulated in metastatic lesions, confirming its intended pharmacokinetic profile.
Based on joint research conducted at Michigan State University and the Athinoula A. Martinos Center for Biomedical Imaging in the Department of Radiology and Massachusetts General Hospital and Harvard Medical School, additional preclinical data were published in Oncotarget highlighting the potential for microRNA-based therapies in glioblastoma multiforme (GBM). The publication included in vivo animal studies confirming the inhibitory effect of TTX-MC138 on the growth of stem cell-derived orthotopic GBM xenografts, suggesting miR-10b may represent a useful target in GBM therapy.
Conversion of the Company’s convertible promissory notes into common stock upon completion of the initial public offering (IPO) in July.
Key Planned Upcoming Milestones

TransCode’s goals to continue to advance its portfolio include:

TTX-MC138
Submission to FDA of an eIND application by second quarter 2022.
Initiation of a FIH Phase 0 clinical study evaluating TTX-MC138 for treatment of metastatic solid tumors later in 2022.
Concurrent completion of IND-enabling studies to support a second half 2022 filing of an IND application for a Phase I clinical trial of TTX-MC138.
Publication in the first half of 2022 of preclinical results supporting the TTX delivery platform in pancreatic cancer and glioblastoma multiforme.
Filing of additional patents related to new and current technologies.
Continuation of pre-clinical studies for therapeutic candidates TTX-RIGA, TTX-siPDL1 and TTX-siLin28b
Third Quarter Financial Highlights

Cash and Cash Equivalents: As of September 30, 2021, cash and cash equivalents totaled approximately $22.5 million largely reflecting the net proceeds from the July IPO.
R&D Expenses: Research and development expenses were approximately $993 thousand in the third quarter of 2021, compared to approximately $54 thousand in the third quarter of 2020. The increase was primarily due to purchases of materials, compensation costs which the Company did not have prior to the third quarter of 2021 except for stock-compensation expenses, license fees, intellectual property expenses, and lab facility expenses.
G&A Expenses: General and administrative expenses were approximately $1.4 million in the third quarter of 2021, compared to approximately $186 thousand in the third quarter of 2020. The increase was primarily due to increased liability insurance costs, compensation and related personnel costs which the Company did not have in the 2020 period except for stock- compensation expenses, investor relations and other costs of being a public company, and expenses for legal, accounting and tax services.
Operating Loss: Operating loss was approximately $2.4 million in the third quarter of 2021, compared to approximately $239 thousand in the third quarter of 2020. Net loss for the 2021 third quarter was approximately $2.3 million, or $0.20 per basic and diluted share, compared to a net loss of approximately $1.4 million, or $0.30 per basic and diluted share, for the third quarter of 2020. The Company expects that operating losses will increase substantially in the foreseeable future.
Financial Guidance

TransCode expects that its cash and cash equivalents as of September 30, 2021, together with additional funding expected from an April 2021 SBIR award, are sufficient to fund planned operations through year-end 2022.