On August 6, 2020 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, 2020, and provided an update on programs and progress (Press release, Synlogic, AUG 6, 2020, View Source [SID1234563120]).

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"Our team at Synlogic continues to achieve our clinical programs and platform milestones, driving the advancement of our portfolio of novel Synthetic Biotic medicines," said Aoife Brennan, M.B. Ch.B., Synlogic’s president and chief executive officer. "We are on track to initiate the Phase 2 study of SYNB1618 in Phenylketonuria and the monotherapy arm of our Phase 1 trial of SYNB1891 in solid tumors continues to progress as planned. With the advancement of our pipeline and a cash runway into 2022, we are well positioned to meet our objectives and bring these novel Synthetic Biotic medicines to patients."

"We have rapidly advanced SYNB8802 in Enteric Hyperoxaluria, which leads to dangerously high levels of urinary oxalate and for which patients have few treatment options today," said Richard Riese, M.D., Synlogic’s chief medical officer. "We look forward to an IND filing and moving SYNB8802 into the clinic in early 2021."

2020 Priorities & Highlights

Initiation of a Phase 2 clinical trial to evaluate SYNB1618 in patients with phenylketonuria (PKU). SYNB1618 is an orally administered Synthetic Biotic medicine being developed as a potential treatment for PKU.
Synlogic expects to initiate the Phase 2 clinical trial of SYNB1618 in the second half of 2020, per plan.
The Phase 2 trial is designed to evaluate safety and tolerability of a solid formulation of SYNB1618 as well as its potential to lower blood phenylalanine levels in PKU patients.
In addition, the study is expected to provide valuable information to validate predictive pharmacodynamic and preclinical modeling.
Continuation of the monotherapy arm of the Phase 1 clinical study of SYNB1891 in patients with advanced solid tumors or lymphoma. SYNB1891 is currently in Phase 1 clinical development in patients with advanced solid tumors or lymphoma.
Enrollment in the Phase 1 trial continues per plan
Synlogic expects to share data from the monotherapy arm of the Phase 1 clinical study before the end of the year
Advancement of SYNB8802 for the treatment of enteric hyperoxaluria
Synlogic is developing SYNB8802 to treat enteric hyperoxaluria. SYNB8802 has moved into IND-enabling studies.
Enteric hyperoxaluria is an acquired metabolic disorder in which patients develop recurrent kidney stones due to elevated urinary oxalate levels and are at an increased risk of kidney failure.
Synlogic regains all rights to develop Synthetic Biotic medicines for all effectors targeting IBD
On May 21, Synlogic announced the termination of its collaboration with AbbVie.
Upon termination, Synlogic regained all rights to develop IBD Synthetic Biotic medicines for all effectors targeting IBD. This allows Synlogic to fully leverage its expertise in strain engineering, quantitative biology, regulatory, and manufacturing to expand its wholly owned GI-based program portfolio to include IBD.
Synlogic further regains the rights to partner its IBD programs.
First virtual R&D event
On May 27, Synlogic’s Executive Team presented an in-depth review of our Synthetic Biotic medicines platform and programs for the treatment of metabolic diseases, inflammatory and immune disorders, and cancer. The team was joined by guest speaker David S. Goldfarb, Professor of Medicine and Physiology and Clinical Chief, Division of Nephrology at NYU School of Medicine; Chief, Nephrology at NY Harbor VA Medical Center, for an overview of enteric hyperoxaluria.
The R&D event materials and replay can be found in the Presentations & Publications section of the Synlogic website
Synlogic expands Leadership Team and announces senior management promotions
Synlogic promoted Antoine (Tony) Awad to the position of Chief Operating Officer.
Tony joined Synlogic in December 2018 as Head of Technical Operations. He brings over 15 years of experience in the biotechnology and pharmaceutical industry with substantial experience in the development and manufacturing of novel therapeutics from pre-IND studies through global commercialization. Prior to joining Synlogic, Tony served as Senior Vice President of CMC and Operations at Abpro Therapeutics and L.E.A.F. Pharmaceuticals and served in roles of increasing responsibility at Ipsen Biosciences and Merrimack Pharmaceuticals. Tony is a graduate of Boston University and holds degree in biochemistry and molecular biology, and conducted graduate research at Boston University School of Dental Medicine.
Synlogic also announced the appointment of Andrew Marsh as Head of Clinical Operations.
Andrew brings over 15 years of experience across an array of therapeutic areas, including rare diseases and oncology, and has executed initial IND through registrational human clinical studies. Prior to joining Synlogic he served as Ra Pharmaceuticals’ Head of Clinical Development. Andrew is a graduate of Boston University and holds a degree in biomedical engineering. He will be responsible for Clinical Operations, Biometrics, and Clinical Bioanalytics.
Second Quarter 2020 Financial Results
As of June 30, 2020, Synlogic had cash, cash equivalents, and short-term investments of $109.1 million.

For the three months ended June 30, 2020, Synlogic reported a consolidated net loss of $15.5 million, or $0.44 per share, compared to a consolidated net loss of $12.3 million, or $0.45 per share, for the corresponding period in 2019.

Research and development expenses were $12.9 million for the three months ended June 30, 2020 compared to $9.7 million for the corresponding period in 2019.

General and administrative expenses for the three months ended June 30, 2020 were $3.5 million compared to $3.7 million for the corresponding period in 2019.

Revenues were $0.4 million for both the three months ended June 30, 2020 and June 30, 2019, respectively. Revenue for both periods was associated with Synlogic’s prior collaboration with AbbVie to develop Synthetic Biotic medicines for the treatment of irritable bowel disease.

Financial Outlook
Based upon its current operating plan, Synlogic expects to have a projected cash runway into 2022.

Conference Call & Webcast Information
Synlogic will host a conference call and live webcast today at 8:00 a.m. ET today, Thursday, 6 August 2020. To access the live webcast, please visit the "Event Calendar" page within the Investors and Media section of the Synlogic website.

Alternatively, 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 5673797. For those unable to participate in the conference call or webcast, a replay will be available for 30 days on the Investors and Media section of the Synlogic website.

On August 6, 2020 IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, reported its financial results for the second quarter ended June 30, 2020 and provided an update on recent developments (Press release, IGM Biosciences, AUG 6, 2020, View Source [SID1234563119]).

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"We continue to make steady progress advancing our pipeline of engineered IgM antibodies," said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. "Today, we are pleased to announce that the FDA has cleared our Investigational New Drug (IND) application for IGM-8444, our anti-Death Receptor 5 IgM antibody, which we believe may prove to be helpful in treating a broad range of solid and hematologic malignancies. Later this year, we look forward to beginning our Phase 1 trial of IGM-8444 in solid cancers and to sharing our initial clinical data from our Phase 1 trial of IGM-2323 in relapsed/refractory NHL."

IGM-8444

Investigational New Drug (IND) application for IGM-8444 cleared by the U.S. Food and Drug Administration (FDA). IGM reported that the FDA has cleared the Company to proceed to conduct clinical trials pursuant to its IND for IGM-8444, an IgM antibody targeting the Death Receptor 5 (DR5) protein, which may prove to be useful for the treatment of patients with solid and hematologic malignancies. The proposed multicenter, open-label Phase 1 clinical trial will evaluate IGM-8444 intravenously administered as a monotherapy and in combination with chemotherapy in patients with relapsed and/or refractory solid cancers. The key objectives of this Phase 1 clinical trial are to provide an initial assessment of pharmacokinetics, safety, biomarkers and preliminary efficacy of IGM-8444 both as a single agent and in combination with standard of care chemotherapy.
Corporate Updates

Kathy Miller, Ph.D., appointed as Vice President, Antibody Discovery. IGM reported the appointment of Kathy Miller, Ph.D., as Vice President, Antibody Discovery. Prior to joining IGM, Dr. Miller served as Vice President, Biotherapeutics at Five Prime Therapeutics from 2015-2020. She has also served in various scientific and leadership roles at Novartis Institutes for Biomedical Research, and at Merck Research Laboratories at the former DNAX/Schering Plough site. Dr. Miller received a B.S. and a Ph.D. in Molecular Genetics from The Ohio State University and conducted post-doctoral research at Genentech.
Phase I Clinical Trial of IGM-2323. IGM is continuing the dose escalation portion of its Phase I clinical trial evaluating IGM-2323 in patients with relapsed/refractory NHL, the first-in-human application of IGM’s engineered IgM antibody technology. IGM continues to expect to present initial data from this clinical trial in the fourth quarter of 2020.
Second Quarter 2020 Financial Results

Cash and Investments: Cash and investments as of June 30, 2020 were $203.1 million, compared to $236.6 million as of December 31, 2019.
Research and Development (R&D) Expenses: For the second quarter of 2020, R&D expenses were $15.0 million, compared to $8.3 million for the same period in 2019.
General and Administrative (G&A) Expenses: For the second quarter of 2020, G&A expenses were $4.4 million, compared to $2.2 million for the same period in 2019.
Net Loss: For the second quarter of 2020, net loss was $18.8 million, or a loss of $0.62 per share, compared with a net loss of $10.7 million, or a loss of $19.08 per share, for the same period in 2019.
Shares Outstanding: Weighted-average shares outstanding for the second quarter of 2020 were 30.6 million, compared to 0.6 million for the same period in 2019.
2020 Financial Guidance

IGM reiterates its previously issued financial guidance which consisted of non-GAAP operating expenses for 2020 of approximately $75 – $85 million, excluding estimated non-cash stock-based compensation expense of approximately $8 million. Including non-cash stock-based compensation expense, IGM estimates GAAP operating expenses for 2020 of $83 – $93 million. IGM also expects to end 2020 with a balance of over $140 million in cash and investments.

On August 6, 2020 IntelGenx Technologies Corp. (TSX-V:IGX) (OTCQB:IGXT) ("IntelGenx"), a leader in pharmaceutical films, reported that it will release its second quarter 2020 financial results after market close on August 13, 2020 (Press release, IntelGenx, AUG 6, 2020, View Source;Conference-Call-to-Follow/default.aspx [SID1234563118]).

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An accompanying conference call will be hosted by Dr. Horst G. Zerbe, Chief Executive Officer, and Mr. Andre Godin, President and Chief Financial Officer, to discuss the results and provide a business update. Details of the conference call and webcast are below:

Date: Thursday, August 13, 2020
Time: 4:30 p.m. ET
Online Registration:Click here

On August 6, 2020 Clovis Oncology, Inc. (NASDAQ:CLVS) reported financial results for the quarter ended June 30, 2020, and provided an update on the Company’s clinical development programs and regulatory and commercial outlook for the rest of the year (Press release, Clovis Oncology, AUG 6, 2020, View Source [SID1234563117]).

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"We are pleased with our U.S. approval in advanced prostate cancer and continued sales growth for Rubraca year over year in the U.S. and Europe, particularly in the face of evident headwinds from COVID-19. Second-quarter revenues were negatively affected, largely due to fewer new patient starts, as oncology practices and patients adjusted to the impact of the virus in the U.S. and Europe," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "We continue to believe that Rubraca has significant advantages as a maintenance option in ovarian cancer and a treatment option for prostate cancer in an environment in which physicians are trying to reduce patient visits to their clinics, and will continue our efforts to engage with clinicians during this period, which is ongoing as resurgences of the virus continue in large U.S. markets. I am pleased that we successfully completed target enrollment in the 1000 patient Phase 3 ATHENA study in front-line, newly diagnosed advanced ovarian cancer maintenance in June in less than two years. We are also particularly enthusiastic to be moving FAP-2286 into the clinic with planned imaging and therapeutic INDs in the fourth quarter."

Second Quarter 2020 Financial Results

Clovis reported net product revenue for Rubraca of $39.9 million for the second quarter of 2020, which included U.S. product revenue of $36.7 million and ex-U.S. product revenue of $3.2 million, compared to net product revenue for Q2 2019 of $33.0 million, which included U.S. net product revenue of $32.7 million and ex-U.S. net product revenue of $0.3 million. U.S. product revenues increased 12 percent in Q2 2020 compared to Q2 2019 and ex-U.S. product revenue increased meaningfully from the first reported ex-U.S. sales in Q2 2019.

Clovis reported net product revenue for Rubraca of $82.5 million for the six months ended June 30, 2020, which included U.S. product revenue of $76.0 million and ex-U.S. product revenue of $6.5 million, compared to net product revenue for same period in 2019 of $66.1 million, which included U.S. net product revenue of $64.6 million and ex-U.S. net product revenue of $1.5 million.

Net product revenue decreased six percent sequentially from Q1 2020 to Q2 2020 principally due to reduced new patient starts which we believe is the result of the effects of COVID-19 in the U.S. and Europe during the quarter. The effects of COVID-19 on future sales are difficult to predict, especially with the increase in COVID-19 cases in the U.S. and Europe.

Clovis had $261.4 million in cash and cash equivalents as of June 30, 2020, including $82.8 million in net proceeds in an equity offering of 11.1 million shares of common stock in May 2020.

The Company has reduced its total outstanding convertible debt by $145.1 million in outstanding principal amount from December 31, 2019 through June 30, 2020.

As of June 30, 2020, the Company had drawn approximately $68 million under the TPG ATHENA clinical trial financing and had up to $107 million available to draw under the agreement to fund the expenses of the ATHENA trial through Q3 2022.

Based on the Company’s anticipated revenues, spending, available financing sources and existing cash and cash equivalents, the Company believes it has sufficient cash and cash equivalents to fund its operating plan into early 2022, after taking into account any cash repayment (unless refinanced earlier) of the remaining $64.42 million aggregate principal amount of the 2.50% convertible notes, at their maturity in September 2021.

Net cash used in operating activities was significantly lower at $59.9 million for the second quarter of 2020, compared with $98.0 million for the second quarter of 2019. Similarly, net cash used in operating activities for the first half of 2020 was $142.4 million, compared with $196.5 million for the first half of 2019.

Borrowings under the TPG ATHENA financing provided $17.7 million in cash in Q2 2020, and we paid a milestone payment to Pfizer of $8.0 million for the U.S. mCRPC approval. Cash burn in Q2 2020 was $50.1 million, which represents a 25 percent decline from the Q1 2020 cash burn of $66.9 million. Cash burn in the first half of 2020 was $117.0 million.

Clovis reported a net loss for the second quarter of 2020 of $92.2 million, or ($1.15) per share, and a net loss of $191.6 million, or ($2.52) per share, for the first half of 2020. Net loss for Q2 2019 was $120.4 million, or ($2.27) per share, and $206.9 million, or a net loss of ($3.91) per share, for the first half of 2019. Net loss for Q2 and the first half of 2020 included share-based compensation expense of $13.3 million and $26.3 million, compared to $14.1 million and $27.8 million for the comparable periods of 2019.

Research and development expenses totaled $69.9 million for Q2 2020 and $138.1 million for the first half of 2020, compared to $70.7 million and $132.8 million for the comparable periods in 2019. Research and development expenses remained relatively flat for the second quarter and increased slightly for the first half of 2020 compared to the same period in the prior year. We expect research and development expenses to be lower in the full year 2021 compared to full year 2020.

Selling, general and administrative expenses totaled $41.9 million for Q2 2020 and $84.5 million for the first half of 2020, compared to $48.0 million and $95.8 million for the comparable periods in 2019. Selling, general and administrative expenses decreased during the second quarter and first half of 2020 compared to the same period in the prior year with savings due to the COVID-19 situation globally and overall cost reduction efforts.

U.S. Approval and Label Expansion for Rubraca now includes BRCA1/2-mutant mCRPC

On May 15, 2020, the U.S. FDA approved Rubraca for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castrate-resistant prostate cancer who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. The FDA approved this indication under accelerated approval based on objective response rate and duration of response data from the multi-center, single arm TRITON2 clinical trial.

In late May, the National Comprehensive Cancer Network (NCCN) updated its Clinical Practice Guidelines in Oncology for Prostate Cancer to include new recommendations for Rubraca. In addition to its ovarian cancer recommendations, Rubraca is now recommended in the NCCN Guidelines for the treatment of patients with BRCA-mutant tumors with mCRPC under second-line treatment and subsequent therapy as a Category 2A recommendation inclusive of the following:

Rucaparib is a treatment option for patients with mCRPC and a pathogenic BRCA1 or BRCA2 mutation (germline and/or somatic) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. If the patient is not fit for chemotherapy, rucaparib can be considered even if taxane-based therapy has not been given.

Target Enrollment Completed in the Phase 3 ATHENA Study

In June, the Company announced the completion of target enrollment of 1000 patients in the Clovis-sponsored Phase 3 ATHENA trial evaluating Rubraca as monotherapy and the combination of Rubraca and Opdivo as front-line maintenance treatment of newly-diagnosed advanced ovarian cancer. ATHENA is the first front-line switch maintenance study designed to evaluate PARP monotherapy and PARP/PD-1 combination therapy in one study design. Target enrollment of 1000 patients in the ATHENA study was achieved in less than two years with the support and involvement of the Gynecologic Oncology Group (GOG) and the European Network for Gynecological Oncological Trials (ENGOT), two of the largest cooperative groups in the U.S. and Europe dedicated to the treatment of gynecological cancers.

In addition, three abstracts describing data from rucaparib monotherapy or combination clinical trials were accepted for e-poster presentation at the 2020 ESMO (Free ESMO Whitepaper) Virtual Congress in September.

Lucitanib Combination Studies Underway

Two Clovis-sponsored early Phase 1b/2 lucitanib combination studies are currently underway: LIO-1, evaluating lucitanib and Opdivo in combination in advanced solid tumors (Phase 1b) and gynecologic cancers (Phase 2); and lucitanib in combination with rucaparib in advanced solid tumors (Phase 1b) and ovarian cancer (Phase 2) as an arm of the SEASTAR study. An abstract describing the initial Phase 1b clinical experience of lucitanib in combination with Opdivo (LIO-1) has been accepted as an e-poster for the 2020 European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress to be held in September. In addition, the Phase 2 portion of LIO-1 recently opened for enrollment and treated the first patient in the trial, and a Trials-In-Progress e-poster describing the trial design was also accepted for the 2020 ESMO (Free ESMO Whitepaper) Virtual Congress.

FAP-2286 and Peptide-Targeted Radiotherapy Development Program

The Company’s peptide-targeted radiopharmaceutical therapy development program includes lead compound FAP-2286 and three additional unnamed preclinical targets. An abstract describing the first presentation of FAP-2286 preclinical data in animal models has been accepted for the 2020 ESMO (Free ESMO Whitepaper) Virtual Congress, and during Q4 2020, Clovis intends to submit two Investigational New Drug (IND) applications for FAP-2286 for use as imaging and treatment agents respectively. Upon activation of the INDs by the U.S. FDA, Clovis will initiate a Phase 1 study to determine the dose and tolerability of the FAP-targeting therapeutic agent, with expansion cohorts planned in multiple tumor types. The FAP-targeting imaging agent will be utilized to identify tumors that contain FAP for treatment in the Phase 1 study.

Conference Call Details

Clovis will hold a conference call to discuss Q2 2020 results this afternoon, August 6, at 4:30pm ET. The conference call will be simultaneously webcast on the Clovis Oncology web site www.clovisoncology.com, and archived for future review. Dial-in numbers for the conference call are as follows: US participants (877) 698-7048, International participants (647) 689-5448, conference ID: 7155799.

About Rubraca (rucaparib)

Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed multiple tumor types, including ovarian and prostate cancers, as monotherapy and in combination with other anti-cancer agents. Exploratory studies in other tumor types are also underway. Clovis holds worldwide rights for Rubraca.

In the United States, Rubraca is approved for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Rubraca is also approved in the United States for the treatment of adult patients with deleterious BRCA mutation (germline and/or somatic) associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies and selected for therapy based on an FDA-approved companion diagnostic for Rubraca. Additionally, Rubraca is approved in the U.S. for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. Patients should be selected for treatment with Rubraca based on the presence of a deleterious BRCA mutation (germline and/or somatic). This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. The TRITON3 clinical trial is expected to serve as the confirmatory study for the Rubraca accelerated approval in mCRPC.

In Europe, Rubraca is approved for the maintenance treatment of adults with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy. Rubraca is also approved in Europe for the treatment of adult patients with platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum-based chemotherapy, and who are unable to tolerate further platinum-based chemotherapy.

Rubraca is an unlicensed medical product outside of the U.S. and Europe.

About Lucitanib

Lucitanib is an oral, potent inhibitor of the tyrosine kinase activity of vascular endothelial growth factor receptors 1 through 3 (VEGFR1-3), platelet-derived growth factor receptors alpha and beta (PDGFRα/ß) and fibroblast growth factor receptors 1 through 3 (FGFR1-3). Emerging clinical data support the combination of angiogenesis inhibitors and immunotherapy to increase effectiveness in multiple cancer indications. Angiogenic factors, such as vascular endothelial growth factor (VEGF), are frequently up-regulated in tumors and create an immunosuppressive tumor microenvironment. Use of antiangiogenic drugs may reverse this immunosuppression and augment response to immunotherapy.

Lucitanib is an unlicensed medical product.

About FAP-2286

FAP-2286 is a preclinical candidate discovered by 3B Pharmaceuticals under investigation as a peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting fibroblast activation protein alpha (FAP). FAP is highly expressed in many epithelial cancers, including more than 90 percent of breast, lung, colorectal and pancreatic carcinomas. Clovis is planning to submit an investigational new drug application (IND) for FAP-2286 in the second half of 2020. Clovis will conduct the global clinical trials and holds U.S. and global rights, excluding Europe.

FAP-2286 is an unlicensed medical product.

On August 6, 2020 Molecular Templates, Inc. (Nasdaq: MTEM, "Molecular Templates," "MTEM" or "the Company"), a clinical-stage biopharmaceutical company focused on the discovery and development of proprietary targeted biologic therapeutics, engineered toxin bodies (ETBs), reported financial results for the second quarter of 2020 (Press release, Molecular Templates, AUG 6, 2020, View Source [SID1234563116]).

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"Since our last quarterly update, we presented preclinical data at AACR (Free AACR Whitepaper) on four preclinical ETB programs, provided an update on the ongoing Phase I study for MT-5111, and strengthened our balance sheet through a new debt facility and our ATM," said Eric Poma, Ph.D., Molecular Templates’ Chief Executive and Chief Scientific Officer. "In the second half of 2020, we expect to report interim clinical data from our three MT-3724 Phase 2 studies and additional data from the MT-5111 Phase 1 study, and also file the IND for MT-6402, our PD-L1-targeted ETB with antigen seeding."

Company Highlights, Pipeline Status, and Upcoming Milestones

Corporate

On May 22, 2020, MTEM announced it had secured a debt financing facility for up to $45 million from K2 HealthVentures, a healthcare-focused specialty finance company. MTEM received a first tranche of $15 million upon closing. Two subsequent tranches totaling $30 million will become available upon the achievement of certain milestones.
In July 2020, MTEM raised $50 million in gross proceeds from its At-The-Market Facility (ATM).
MT-3724 (CD20 ETB)

MTEM is currently conducting three Phase 2 studies with MT-3724 in relapsed/refractory diffuse large B-cell lymphoma (DLBCL): a monotherapy study that has the potential to be pivotal, a combination study with chemotherapy, and a combination study with lenalidomide.
Interim results for the study of MT-3724 in combination with lenalidomide were presented at the 25th Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) virtual meeting in June 2020. This data demonstrated preliminary evidence of tolerability and efficacy with lenalidomide at standard doses and MT-3724. Among 7 evaluable subjects, 2 had CRs and 3 had PRs. While there were no permanent discontinuations due to adverse events, grade 2 capillary leak syndrome occurred at 25 mcg/kg, leading to the opening of a new cohort at 20 mcg/kg. The study now has a new schedule of therapy with MT-3724 being dosed twice rather than three times weekly for the first two cycles, and then on a weekly schedule thereafter.
MTEM expects to report updates on all three MT-3724 DLBCL studies in 2H20.
MTEM also expects to initiate Phase 2 studies for MT-3724 in follicular lymphoma and mantle cell lymphoma in 2H20.
TAK-169 (CD38 ETB)

Takeda and MTEM are conducting an ongoing Phase 1 study evaluating TAK-169 in relapsed/refractory multiple myeloma.
MT-5111 (HER2 ETB)

MTEM is conducting a Phase 1 study of MT-5111 in HER2-positive cancers.
In June 2020, MTEM provided an interim update from the first three dose cohorts of the dose escalation portion of the Phase 1 study. That update noted that 10 subjects, with a median of 5 prior lines of therapy and a median of 2 prior HER2-targeting regimens, have been treated with MT-5111 (metastatic cholangiocarcinoma n=5, metastatic breast cancer n=4, metastatic gastro-esophageal junction carcinoma n=1). Thus far, no dose limiting toxicities (DLTs) have been observed in any cohort and MT-5111 appears to be well tolerated, with no cardiotoxicity observed to date (cardiotoxicity is a known potential toxicity for HER2 targeted therapies).
Further to the June 2020 interim update, MTEM expects to provide an update on results from the subjects still on treatment as well as higher dose cohorts from the dose escalation portion of the Phase 1 study (including doses that are predicted to be clinically active based on preclinical data) in 4Q20.
Research

MTEM presented preclinical data on ETB programs targeting PD-L1, CTLA-4, SLAMF-7 and CD45 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting II, which took place June 22-24, 2020.
MTEM expects to file an investigational new drug (IND) application for MT-6402, its ETB targeting PD-L1 (with antigen seeding), in 2H20.
MTEM expects to file an IND application for its ETB targeting CTLA-4 in 2021.
COVID-19 Impact

The COVID-19 pandemic has resulted in a significant slowdown in the pace of site initiations and patient enrollment across our MT-3724 Phase 2 programs. Much like other sponsors with studies in patients with hematologic malignancies, we are working with sites to determine when a patient is suitable for each research study and to ensure the continued safety of all research participants.
To date, screening and enrollment for the MT-5111 Phase 1 study has been less adversely affected than the MT-3724 studies but it is enrolling at slower pace than was projected pre-COVID-19.
To date, MTEM has been able to continue to work at its cGMP manufacturing facility and laboratories without interruption from COVID-19. As a result, manufacturing of product supply for clinical trials and research activities to support advancement of our preclinical pipeline (including partnered programs) have not been adversely affected by COVID-19 to date.
Financial Results

The net loss attributable to common shareholders for the second quarter of 2020 was $31.2 million, or $0.68 per basic and diluted share. This compares with a net loss attributable to common shareholders of $9.2 million, or $0.25 per basic and diluted share, for the same period in 2019.

Revenues for the second quarter of 2020 were $6.9 million, compared to $5.4 million for the same period in 2019. Revenues for the second quarter of 2020 were comprised of revenues from collaborative research and development agreements with Takeda and Vertex, as well as grant revenue from CPRIT. Total research and development expenses for the second quarter of 2020 were $30.4 million, compared with $10.2 million for the same period in 2019. Total general and administrative expenses for the second quarter of 2020 were $6.4 million, compared with $4.6 million for the same period in 2019.

As of June 30, 2020, MTEM’s cash and investments totaled $91.0 million. With the addition of $50 million in gross proceeds raised through MTEM’s ATM facility after the end of the quarter, MTEM expects to be able to fund operations into 2H22.