On November 13, 2018 Molecular Templates, Inc. (Nasdaq: MTEM, "Molecular" or "Molecular Templates"), a clinical-stage oncology company focused on the discovery and development of the company’s proprietary engineered toxin bodies (ETBs), which are differentiated, targeted, biologic therapeutics for cancer, reported financial results for the third quarter of 2018 (Press release, Molecular Templates, NOV 13, 2018, View Source [SID1234531340]). As of September 30, 2018, Molecular’s cash and cash equivalents totaled $78.7 million, this does not include $30 million received from Takeda in October 2018. Molecular’s current cash balance is expected to fund operations into 1H 2021.

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"Our recently announced CD38 collaboration with Takeda enables the development of TAK-169, the most potent ETB we have created with our platform to date. Importantly, the upfront payment from Takeda and the equity financing that we closed in September provide the funding to allow us to generate clinical data from multiple pipeline candidates throughout 2019 and beyond," said Eric Poma, Ph.D., Molecular Templates’ Chief Executive and Scientific Officer. "In 2019, our lead program MT-3724 will be in multiple Phase II studies and we expect to start clinical trials for three additional ETBs targeting CD38, HER2, and PD-L1."

Company Highlights and Upcoming Milestones

Corporate

On September 19, 2018, Molecular announced an agreement with Takeda for the joint development of CD38-targeted ETBs for the treatment of multiple myeloma. TAK-169, the lead development candidate, is a CD38-targeted ETB that resulted from a previous discovery collaboration between the two companies. Under the terms of the agreement, Takeda made an upfront payment of $30 million and Molecular is eligible to receive development, regulatory and commercial milestone payments of up to $632.5 million if Molecular exercises its co-development option or $337.5 million if Molecular does not exercise or opts out of its co-development option. Takeda has also agreed to pay royalties on the sales of the commercial products developed through the collaboration. The royalty percentages would range from low double-digits to low twenties if Molecular exercises its option to co-develop, and from high-single digits to low teens if Molecular does not exercise its option to co-develop. Molecular and Takeda will share equally in the development costs.
On September 18, 2018, Molecular entered into a Cancer Research Grant Contract with the Cancer Prevention and Research Institute of Texas (CPRIT), in connection with a grant of approximately $15.2 million awarded by CPRIT to Molecular in November 2016 to fund research of a cancer therapy involving a CD38 targeting ETB (MT-4019). Molecular may also use such funds to develop a replacement CD38 targeting ETB, with or without a partner and expects to use this grant to fund development of TAK-169.
On September 25, 2018, Molecular announced the closing of an underwritten public offering of its common stock, which generated gross proceeds of approximately $52 million.
TAK-169

Following the announcement of the CD38 joint development agreement in September, Takeda and Molecular are conducting IND enabling studies for TAK-169, which is expected to enter the clinic for the treatment of multiple myeloma in 2019.
MT-3724

Molecular expects to begin enrollment in 4Q18 for a Phase II combination study with MT-3724 and chemotherapy in earlier lines of diffuse large B-cell lymphoma (DLBCL).
In 1Q19 Molecular expects to start a Phase II monotherapy study, which has the potential to be a pivotal study.
Molecular expects to initiate a second Phase II combination study with MT-3724 and Revlimid (lenalidomide) in earlier lines of DLBCL in 1Q19.
Research

Molecular expects to file an IND application for an ETB targeting HER2 in 1Q19.
Molecular expects to file an IND application for an ETB targeting PD-L1 (with antigen seeding) in 2H19.
Several other ETB candidates are in pre-clinical development, targeting both solid and hematological cancers.
Takeda Multi-Target Collaboration

Takeda and Molecular are conducting lead optimization for ETBs against two undisclosed targets selected by Takeda under the collaboration. Should Takeda exercise its option to license ETBs for both targets, Molecular would receive $25 million and would be eligible to receive up to $547 million in milestone payments and tiered royalties on sales.
Financial Results

The net loss attributable to common shareholders for the third quarter of 2018 was $5.2 million, or ($0.19) per basic and diluted share. This compares with a net loss attributable to common shareholders of $11.1 million, or ($0.62) per basic and diluted share, for the same period in 2017.

Revenues for the third quarter of 2018 were $6.8 million, compared to $0.6 million for the same period in 2017. Revenues for the third quarter of 2018 were comprised of grant revenue from the Cancer Prevention & Research Institute of Texas, and revenues from collaborative research and development agreements. Total research and development expenses for the third quarter of 2018 were $8.3 million, compared with $2.5 million for the same period in 2017. Total general and administrative expenses for the third quarter of 2018 were $3.5 million, compared with $4.0 million for the same period in 2017.

The net loss attributable to common shareholders for the nine months ended September 30, 2018 was $23.7 million, or ($0.87) per basic and diluted share. This compares with a net loss attributable to common shareholders of $17.2 million, or ($2.75) per basic and diluted share, for the same period in 2017.

Revenues for the nine months ended September 30, 2018 were $8.6 million, compared to $2.6 million for the same period in 2017. Revenues for the nine months ended September 30, 2018 were comprised of grant revenue from the Cancer Prevention & Research Institute of Texas, and revenues from collaborative research and development agreements. Total research and development expenses for the nine months ended September 30, 2018 were $22.6 million, compared with $4.8 million for the same period in 2017. Total general and administrative expenses for the nine months ended September 30, 2018 were $10.2 million, compared with $8.2 million for the same period in 2017

On November 13, 2018 AC Immune SA (NASDAQ: ACIU), a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases, reported financial results for the three and nine months ended September 30, 2018 (Press release, AC Immune, NOV 13, 2018, View Source [SID1234531243]).

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Prof. Andrea Pfeifer, CEO of AC Immune, commented: "During the third quarter we raised USD 117.5 million, and broadened our shareholder base with 11 new institutional investors. We are grateful for the continued support of our existing shareholders who also participated. These proceeds are expected to fund our three pillar strategy through at least 2021, excluding potential incoming milestones. This capital raise, and the established investors who participated, are a strong endorsement of our scientific pipeline and business model."

"We also continued to advance key assets in our pipeline, announcing both the start and dosing of the first patient in the Phase 2 trial with ACI-24 in patients with mild Alzheimer’s disease and completing recruitment for the high-dose cohort of the Phase 1b study with ACI-24 for Abeta-related cognitive decline in individuals with Down Syndrome. Vaccines are potentially an important option for the treatment and prevention of neurodegenerative diseases and are one of our main targets for clinical development.

A new exploratory Phase 2 data analysis presented at the AAIC 2018 showed that our lead product candidate crenezumab significantly reduces Abeta oligomers in cerebrospinal fluid in patients with Alzheimer’s disease. We are encouraged about crenezumab’s potential as a disease modifying therapy, particularly given its distinct differentiation from other beta-amyloid antibodies in terms of both target specificity and safety."

Key Financial Data – Unaudited (CHF million)

For the three months ended
September 30, For the nine months ended September 30,
2018 2017 2018 2017
(in CHF million except per share data) (in CHF million except per share data)
Total revenue 2.3 1.1 5.8 3.8

R&D expenses (11.5) (8.2) (32.2) (22.5)
G&A expenses (2.9) (2.5) (8.7) (7.0)

IFRS Loss for the period (13.5) (8.8) (36.3) (30.6)
IFRS Loss per Share – basic and diluted (0.21) (0.15) (0.61) (0.54)

Adjusted Loss for the period1 (11.6) (9.0) (33.3) (25.0)
Adjusted Loss Share – basic and diluted1 (0.18) (0.16) (0.56) (0.44)

1 Adjusted (Loss) and Adjusted Loss per Share are non-IFRS measures. See "Non-IFRS Financial Measures" below for further information and reconciliation to the most directly comparable IFRS measures.

As of
September 30, As of
December 31,

2018 2017 Change
(in CHF million)
Cash and cash equivalents 199.1 124.4 74.7
Total shareholder’s equity 192.0 116.8 75.2
Third Quarter 2018 Company Highlights

ACI-24 Vaccine for Alzheimer’s Disease
AC Immune has started the Phase 2 study with ACI-24 in patients with mild Alzheimer’s disease (AD). The aim of this double-blind, randomized, placebo-controlled study with an adaptive design is to assess the safety, tolerability, immunogenicity, target engagement, biomarkers and clinical efficacy of ACI-24. The trial will seek to confirm the positive trends on Abeta PET imaging and clinical measurement (CDR-SB) of the previous Phase 1 safety study. The Phase 2 trial will be conducted in several European countries and the first patients have been screened.

ACI-24 in Down Syndrome
AC Immune has completed recruitment for the high-dose cohort of the ACI-24 Phase 1b study for the treatment of Alzheimer’s disease-like characteristics in adults with Down Syndrome (DS), a condition affecting approximately one in 700 newborns. The first low-dose and the second high-dose cohorts have been fully recruited in August 2017 and in July 2018 respectively, and interim results of the low dose cohort are expected later in 2018. In addition to cognitive dysfunction beginning in childhood, individuals with DS are genetically-predisposed to develop Abeta-related cognitive decline at a much younger age and with much greater probability than the general population.

Closing of Three Primary Offerings for 10,000,000 Common Shares
In July, the Company completed three offerings, totaling 10,000,000 new common shares at a price per share of USD 11.75, from which the Company obtained gross proceeds of approximately USD 117.5 million (CHF 116.3 million). Net underwriting fees and transaction costs totaled CHF 6.8 million, yielding net proceeds of CHF 109.5 million.

Third Quarter 2018 Financial Highlights

Revenues
Our revenues fluctuate as a result of our collaborations with current and potentially new partners, the timing of milestone achievements, and the size of each milestone payment.

AC Immune generated revenues of CHF 2.3 million in the three months ended September 30, 2018, an increase of CHF 1.2 million over the comparable period in 2017. Contract revenues improved due to an incremental CHF 0.8 million for research and development services performed for the anti-pTau Vaccine (ACI-35) together with Janssen, CHF°0.2°million related to the TDP-43 PET Imaging Tracers Biogen collaboration and CHF 0.1 million for research services provided to Essex Bio-Technology. We also recognized CHF 0.1 million in grant revenue from the Michael J. Fox Foundation.

We recognized CHF 5.8 million in the nine months ended September 30, 2018, a CHF°2.0°million increase over the comparable period in 2017. Contract revenues improved principally due to increases of CHF 1.6 million for research and development services performed for the anti-pTau Vaccine (ACI-35) together with Janssen, CHF°0.5 million for research services provided to Essex Bio-Technology and CHF 0.5 million for research and development revenues from Biogen. The Company also recorded CHF 0.3 million in grant revenue from the Michael J. Fox Foundation. This was offset by a non-recurring CHF 1.1 million milestone in Q1 2017 from Life Molecular Imaging (formerly Piramal Imaging).

Research & Development (R&D) Expenses
For the three months ended September 30, 2018, AC Immune invested CHF 11.5 million in research and development, compared with CHF 8.2 million for the same period in 2017. The increase in R&D spending was primarily driven by investments in a variety of our programs. In our Alzheimer’s disease programs, this includes an incremental CHF 1.6 million for our anti-pTau Vaccine (ACI-35) program. The increase in our discovery programs of CHF 1.4 million was driven by a variety of projects including CHF 0.3 million related to the continued proof of concept studies and additional manufacturing activities of our lead compounds in the Tau Morphomers and a CHF 0.4 million increase related to manufacturing activities in our vaccine technology program.

For the nine months ended September 30, 2018, AC Immune invested CHF 32.2 million in research and development, compared with CHF 22.5 million for the same period in 2017. The increase in R&D spending was primarily driven by investments of CHF°3.8 million in our Alzheimer’s disease programs, specifically a CHF 1.2 million increase for our ACI-24 program in Alzheimer’s disease (AD) to start-up the Phase 2 study. We also invested an incremental CHF 2.8 million for our anti-pTau Vaccine (ACI-35) program. Importantly, we increased our investments in our Discovery programs by CHF°3.9 million, driven by a CHF 1.8 million increase for preparing the Phase 1 entry of our lead compounds in the Tau MorphomersTM program. Additionally, there were CHF°0.6 million increases related to our vaccine technology program and CHF°0.5°million for our anti-alpha-Synuclein antibody.

General and Administrative (G&A) Expenses
General and administrative expenses amounted to CHF 2.9 million in the three months ended September 30, 2018, compared with CHF 2.5 million in the same period in 2017. For the nine months ended September 30, 2018, and 2017, general and administrative expenses were CHF 8.7 million and CHF 7.0 million, respectively. The changes predominantly related to increases in personnel expenses.

IFRS Loss for the period
For the three months ended September 30, 2018, the Company had a net loss of CHF 13.5 million compared with net loss of CHF 8.8 million for the same period in 2017. The increased net loss for this three month period was partly attributable to the CHF 3.8 million increase in R&D and G&A expenses and CHF 2.2 million decrease in Finance result offset by the CHF 1.2 million in revenues additional revenues.

For the nine months ended September 30, 2018, the Company had a net loss of CHF 36.3 million compared with net loss of CHF 30.6 million for the same period in 2017. The increase in net loss for this nine month period was attributable to the increased spending of CHF 11.3 million in R&D and G&A expenses offset by gains in our Finance result of CHF 3.6 million and CHF 2.0 million in revenues.

Cash position
As of September 30, 2018, AC Immune had total cash and cash equivalents of CHF 199.1 million compared to CHF°124.4 million as of December 31, 2017. This CHF 74.7 million increase was principally due to the Company’s three follow on offerings which yielded a CHF 109.5 million in proceeds, after deducting underwriting fees and transaction costs. Net cash flows used in operating activities of CHF 32.3 million offset this cash increase, due to the higher investments in our major discovery and development programs, and the continued strengthening of the Company’s infrastructure, systems and organization as a publicly-traded company.

Non-IFRS Financial Measures
In addition to our operating results, as calculated in accordance with International Financial Reporting Standards, or IFRS, as adopted by the International Accounting Standards Board, we use Adjusted Loss and Adjusted Loss per Share when monitoring and evaluating our operational performance. Adjusted Loss is defined as loss for the relevant period, as adjusted for certain items that we believe are not indicative of our ongoing operating performance. Adjusted Loss per Share is defined as Adjusted Loss for the relevant period divided by the weighted-average number of shares for such period. The following table reconciles net loss to Adjusted Loss and Adjusted Loss per Share for the periods presented:

Reconciliation of Loss to Adjusted Loss and Loss Per Share to Adjusted Loss Per Share (unaudited)

Weighted-average number of shares used to compute Adjusted Loss per Share – basic and diluted 64,862,822 57,164,145 59,912,283 57,023,032

1 Reflects non-cash expenses associated with share-based compensation for equity awards issued to Directors, Management and employees of the Company.
This expense reflects the awards’ fair value recognized for the portion of the equity award which is vesting over the period.

2 Reflects foreign currency remeasurement gains and losses for the period, predominantly impacted by the change in the exchange rate between the US Dollar and the Swiss Franc.

Non-IFRS Expenditures
Adjustments for the three and nine months ended September 30, 2018, were CHF 1.9 million and CHF 3.0 million, respectively. These were largely due to foreign currency remeasurement losses of CHF 1.3 million and CHF 1.1 million, respectively, predominantly related to the cash balance of the Company as a result of a weakening of the US Dollar against the Swiss Franc for most of the third quarter. The Company also recorded CHF 0.6 million and CHF 1.9 million for the three and nine months, respectively, for share-based compensation expenses. The latter represented a CHF 1.0 million increase compared to the nine months ended September 30, 2017.

On November 13, 2018 Synlogic, Inc. (Nasdaq: SYBX), a clinical stage company applying synthetic biology to beneficial microbes to develop novel, living medicines, reported its financial results for the third quarter ended September 30, 2018, and provided an update on its programs (Press release, Synlogic, NOV 13, 2018, View Source [SID1234531263]).

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"This is an exciting time for Synlogic, as we continue to explore the breadth of our platform. We have advanced SYNB1891, our dual innate immune activator for the treatment of cancer into IND-enabling studies," said Aoife Brennan, M.B., B.Ch., Synlogic’s president and chief executive officer. "Our two orally administered Synthetic Biotic medicines, SYNB1618 for the treatment of phenylketonuria and SYNB1020 for the treatment of hyperammonemia, have demonstrated proof of mechanism in healthy volunteers and we look forward to clinical data from the ongoing clinical trials in patients in 2019."

Recent Highlights
Pipeline

Presentation of preclinical data highlighting potential of Synthetic Biotic medicines in immuno-oncology (IO) and declaration of first IO clinical candidate at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) annual meeting. Data presented at the meeting demonstrate the platform’s potential for the treatment of cancer and inflammation and specifically highlight the unique advantages of Synlogic’s approach to stimulate the innate immune system. Based on preclinical data Synlogic is advancing SYNB1891, a STING-agonist producing synthetic biotic strain, into IND-enabling studies. Synlogic hosted an investor and analyst event at the SITC (Free SITC Whitepaper) annual meeting, featuring presentations by key opinion leaders (KOLs), and members of Synlogic management who outlined development plans for SYNB1891. A webcast of the event is available on the Synlogic website.
Presentation of preclinical data supporting continued development of SYNB1020 for the treatment of liver disease at the American Association for the Study of Liver Diseases (AASLD) annual meeting. Preclinical data were presented demonstrating dose dependent lowering of blood ammonia by Synthetic Biotic strains designed to consume ammonia and produce arginine in a rat bile duct ligation model confirming earlier preclinical observations in mouse models of liver disease. In addition, data were presented from studies conducted by Synlogic to establish ammonia measurement parameters and ammonia levels in healthy volunteers at clinical sites that are participating in Synlogic’s ongoing Phase 1b/2a clinical trial of SYNB1020 in patients with cirrhosis and elevated ammonia. Topline data from this clinical trial are now expected in mid-2019 due to slower than expected rates of initiation of clinical trial sites and patient enrollment.
Announcement of positive interim data from healthy volunteer (HV) arm of its ongoing Phase 1/2a clinical trial evaluating SYNB1618 for the treatment of Phenylketonuria (PKU): Data established a go-forward dose for the treatment arm in patients with PKU and demonstrated a statistically significant, dose-dependent effect on treatment-associated biomarkers, indicating proof-of-mechanism. Synlogic also published preclinical data identifying these same biomarkers in Nature Biotechnology, further supporting SYNB1618’s continued development. The Company continues to evaluate SYNB1618 in patients with PKU in its ongoing Phase 1/2a study and expects to report topline data from this trial in mid-2019.
Corporate

Appointed Aoife Brennan, M.B., B.Ch., as president and chief executive officer: Dr. Brennan had served as interim president and chief executive officer since May 2018 and joined Synlogic as chief medical officer in 2016.
Third Quarter 2018 Financial Results
As of September 30, 2018, Synlogic had cash, cash equivalents, and short-term investments of $132.6 million.

For the three months ended September 30, 2018, Synlogic reported a consolidated net loss of $10.7 million, or $0.43 per share, compared to a consolidated net loss of $11.9 million, or $1.66 per share, for the corresponding period in 2017.

Research and development expenses were $9.9 million for the three months ended September 30, 2018 compared to $9.0 million for the corresponding period in 2017.

General and administrative expenses for the three months ended September 30, 2018 were $3.4 million compared to $3.2 million for the corresponding period in 2017.

Revenues were $1.8 million for the three months ended September 30, 2018, compared to $0.1 million for the corresponding period in 2017. The revenue for both periods is associated with Synlogic’s collaboration with AbbVie to develop a Synthetic Biotic medicine for the treatment of inflammatory bowel disease. The increase in revenue was primarily the result of the achievement of a $2.0 million milestone under a September 2018 amendment to the AbbVie agreement of which $1.8 million was recognized in revenue in the quarter ended September 30, 2018.

Nine-months Results
For the nine months ended September 30, 2018, the consolidated net loss was $36.5 million, or $1.56 per share, compared to a consolidated net loss of $28.7 million, or $7.87 per share, for the corresponding period in 2017.

Total operating expenses were $40.9 million for the nine months ended September 30, 2018, compared to $31.2 million for the corresponding period in 2017. The increase in operating expenses was primarily due to compensation-related expenses associated with increased headcount and increased external costs associated with development of Synlogic’s Synthetic Biotic programs.

Conference Call & Webcast Information
Synlogic will host a conference call and live webcast today at 5:00 p.m. ET today, Tuesday, November 13, 2018. 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 2674209. 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 November 13, 2018 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, reported new positive interim data from its TACTI-mel Phase I clinical trial, presented at the 33rd Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) in Washington, D.C., U.S (Press release, Immutep, NOV 13, 2018, View Source [SID1234531297]).

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The TACTI-mel study is evaluating the use of eftilagimod alpha ("efti" or "IMP321"), a soluble LAG-3Ig fusion protein based on the LAG-3 immune control mechanism, in combination with anti-PD-1 therapy KEYTRUDA (pembrolizumab) for unresectable or metastatic melanoma.

In an oral presentation, Prof. Adnan Khattak, Consultant Medical Oncologist at Fiona Stanley Hospital and a principal investigator of the on-going TACTI-mel study, showed efficacy and safety data from 18 patients in part A, the dose escalation part of the study, and first safety data from 6 patients in part B.

In part A, dose escalation, combination therapy started after four cycles of KEYTRUDA monotherapy. In part B, patients were treated with the combination from the first day of treatment i.e. receiving efti from day one, cycle one with KEYTRUDA.

The efficacy data from part A was encouraging and supportive of previously disclosed response rates with a 33% Overall Response Rate (ORR) when measured from start of the combination at cycle 5 of KEYTRUDA. The ORR was 61% when measured from the start of KEYTRUDA monotherapy treatment in an explorative analysis measuring from cycle 1, day 1. A disease control rate of 66% was reported from the combination treatment. The patient population was partly pre-treated before the start of KEYTRUDA, suboptimally responding to KEYTRUDA and the majority had increased risk factors.

In both parts (A and B), combination therapy has been well tolerated with no dose-limiting toxicities and local erythema and injection site reactions as the most common side effects. Importantly the safety data of part B supports the dose scheduling of the Company’s planned Phase II TACTI-002 clinical study in collaboration with MSD.

Dr. Frédéric Triebel, Immutep’s Chief Scientific Officer and Chief Medical Officer, also commented "We were honored to have been selected for an oral presentation of the data which further supports our hypothesis that combining efti with a checkpoint inhibitor results in a combinatory therapeutic benefit to patients, pushing the accelerator and releasing the brake of the immune system. The data also highlights the excellent safety profile of efti, when combined with an anti-PD-1 therapy."

Prof. Adnan Khattak commented, "We are very pleased with the responses we have observed in this patient population. These patients had a sub-optimal response to pembrolizumab monotherapy. However, after participating in the TACTI-mel study, we have seen good responses in these patients, with a very encouraging overall response rate."

The data was also presented in a poster presentation titled "Results from a Phase I dose escalation trial (TACTI-mel) with the soluble LAG-3 protein (IMP321, eftilagimod alpha) together with pembrolizumab in unresectable or metastatic melanoma."

The trial design of the Company’s planned Phase II TACTI-002 clinical study in collaboration with MSD was presented at SITC (Free SITC Whitepaper) in a poster titled, "A Multicenter, Phase II Study in Patients With First Line NSCLC, or Recurrent PD-X Refractory NSCLC or With Recurrent HNSCC Receiving Eftilagimod Alpha in Combination With Pembrolizumab (TACTI-002)".

Dr. Frédéric Triebel, Immutep’s Chief Scientific Officer and Chief Medical Officer, commented, "We are looking forward to the initiation of TACTI-002 later this year and I believe the clinical trial collaboration and supply agreement that we entered into with MSD earlier this year, as well as the recently announced agreement with Merck KGaA and Pfizer Inc., further supports the development of efti in combination with PD-1 and PD-L1 therapeutics."

The TACTI-mel poster and presentation, along with the TACTI-002 poster are available on Immutep’s website under the "Investor & Media" tab at www.immutep.com/investors-media/presentations.

About the TACTI-mel clinical trial

The ongoing TACTI-mel (Two ACTive Immunotherapies in melanoma) Phase I clinical trial is a multi-center, open-label, dosing escalating (1, 6 or 30 mg of eftilagimod alpha or "efti") study evaluating the combination of efti with pembrolizumab, in unresectable or metastatic melanoma patients that have had either a suboptimal response or had disease progression with pembrolizumab monotherapy (clinicaltrials.gov identifier NCT 02676869).

In Part A of the study, the combination therapy starts at treatment cycle 5 (of pembrolizumab) for 6 months and consists of three cohorts of six patients. Part B is an expansion of the initial study by an additional cohort of 6 patients that receive 30 mg of efti in combination with pembrolizumab starting at cycle 1 and with a treatment duration of 12 months.

On November 13, 2018 Surface Oncology (NASDAQ:SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported financial results and corporate highlights for the third quarter of 2018 (Press release, Surface Oncology, NOV 13, 2018, View Source [SID1234531244]).

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"The team we have assembled at Surface Oncology continues to excel in its execution, both in the clinic with SRF231 and with our later stage preclinical programs targeting CD39 and IL-27," said Jeff Goater, chief executive officer of Surface Oncology. "The overall accomplishments in the field of immuno-oncology have been transformative for patients, but we are driven by the fact that there is so much more to be done to help those affected by cancer. Our diverse portfolio represents a broad and unique approach to fighting cancers, targeting multiple pathways to overcome the immunosuppressive tumor microenvironment."

Selected Corporate Highlights:

Dose escalation continues for phase 1 studies of both SRF231 (CD47) and NZV930 (CD73), with initial data for SRF231 anticipated H1 2019.
IND-enabling studies for both SRF617 (CD39) and SRF388 (IL-27) are ongoing and filings are anticipated around the end of 2019 and early 2020, respectively.
A recent publication in the scientific journal Nature1 highlighted the role of IL-27 in, and its potential as a master switch of, the expression of certain checkpoint proteins.
Two scientific posters highlighting SRF231 were accepted for presentation at the 60th American Society for Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in San Diego, CA:
° "The fully human anti-CD47 antibody SRF231 has dual-mechanism antitumor activity against chronic lymphocytic leukemia (CLL) cells and increases the activity of both rituximab and venetoclax"
° "Targeted inhibition of CD47-SIRP alpha requires Fc-Fc Gamma receptor interactions to maximize phagocytosis in T-Cell lymphomas" (Oral presentation)
Expansion of our facility at 50 Hampshire St., Cambridge, MA began in September. The expansion is slated for completion in Q4 and will add over 12,000 square feet of both laboratory and office space.
Financial Results:
As of September 30, 2018, cash, cash equivalents and marketable securities were $173.4 million, compared to $185.6 million on June 30, 2018. Research and development (R&D) expenses were $15.8 million for the third quarter ended September 30, 2018, compared to $12.1 million for the same period in 2017. The increase was primarily driven by expenditures associated with Surface’s advancing product pipeline, including increased R&D personnel costs associated with the growth of the Company. R&D expenses included $0.5 million in stock-based compensation expenses for the third quarter of 2018.

General and administrative (G&A) expenses were $4.0 million for the third quarter ended September 30, 2018, compared to $4.7 million for the same period in 2017. The decrease was largely due to a one-time charge related to employee separation costs during the quarter ended September 30, 2017, partially offset by increases in professional fees related to legal and accounting services. G&A expenses included $0.7 million in stock-based compensation expenses for the third quarter of 2018.

For the third quarter ended September 30, 2018, net loss was $17.2 million, or basic and diluted net loss per share attributable to common stockholders of $0.62. Net loss was $14.4 million for the same period in 2017, or basic and diluted net loss per share attributable to common stockholders of $5.75.