On May 14, 2018 Immunicom, Inc., a medical technology company developing revolutionary non-pharmaceutical approaches for treating cancer and autoimmune diseases, reported the company has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its Immunopheresis therapy, which is based on a proprietary technology that selectively removes immune inhibitors from a patient’s bloodstream potentially enabling their natural immune system to more-effectively attack cancer tumors (Press release, Immunicom, MAY 14, 2018, View Source [SID1234637423]).

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To achieve Breakthrough Device designation, a technology must demonstrate compelling potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases. In addition, there must be no FDA approved treatments presently available, or the technology must offer significant advantages over existing approved alternatives.
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The FDA’s intent in granting this specific designation to qualified devices is to collaboratively facilitate expediting the device’s assessment and review processes through more interactive communication and planning with the FDA; ensuring proper data collection, efficient clinical study design, senior management engagement of Agency personnel, and priority review of applicable filings.

In contrast to immunotherapy pharmaceuticals and biologicals that introduce foreign compounds and material into a patient’s body, and which are often accompanied by negative side effects, Immunicom’s patented technology is based on a "subtractive" approach that is intended to potentially limit treatment-associated adverse effects. By removing immune system inhibitors from the blood without introducing new substances, Immunicom’s therapeutic approach has been shown in preliminary preclinical studies to enhance anti-cancer immune system response without causing unwanted side effects.
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Immunicom’s blood-filtering device technology is the first step in execution of a broader corporate strategic vision. "We are very pleased with FDA’s granting of Breakthrough Device designation for Immunopheresis, our initial immunotherapy product for treating late/end stage IV cancer patients with metastatic solid tumors," said Amir Jafri, CEO of Immunicom, "This significant milestone will enable us to more efficiently pursue device regulatory approval and address critical unmet patient needs sooner, while also continuing our commitment to invest in other exciting treatment options in our product pipeline."

On May 14, 2018 Intrexon Corporation (NYSE: XON), a leader in the engineering and industrialization of biology to improve the quality of life and health of the planet, reported Lt. General (Ret.) Thomas P. Bostick, PhD, PE, Dist.M. ASCE, NAE, Intrexon’s Chief Operating Officer, and Thomas E. Shrader, PhD, CFA, Vice President, Communications and Strategy, will participate in a fireside chat session at the Bank of America Merrill Lynch 2018 Healthcare Conference at Encore at the Wynn, Las Vegas, Nevada on Tuesday, May 15th, at 5:00 p.m. Pacific Time (Press release, Intrexon, MAY 14, 2018, View Source [SID1234526562]).

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On May 14, 2018 Molecular Templates, Inc. (Nasdaq:MTEM) ("Molecular"), 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 first quarter of 2018 (Press release, Molecular Templates, MAY 14, 2018, View Source [SID1234526587]). As of March 31, 2018, cash and cash equivalents totaled $49.3 million. Molecular’s current cash balance is expected to fund operations into late 2019.

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"We are very pleased with the clinical results we have generated to date for MT-3724, which we expect to enter Phase II studies in relapsed/refractory DLBCL patients in the second half of 2018," said Eric Poma, Ph.D., CEO and CSO of Molecular Templates. "In the next twelve months, we expect our clinical pipeline to expand significantly as we file INDs for MT-4019 as well as our ETBs targeting HER2 and PD-L1."

Company Highlights and Upcoming Milestones

Corporate

At the American Association of Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in April 2018, preclinical data were presented for Molecular’s ETBs targeting PD-L1 (which incorporates Molecular’s Antigen Seeding Technology – a differentiated immune-oncology approach) and HER2.
On March 2, 2018, Molecular closed a $10 million debt facility with Perceptive Advisors. The proceeds were used to repay an existing debt facility with Silicon Valley Bank and will support Molecular’s build out of its GMP manufacturing facility, to support Molecular’s own pipeline as well as partnerships. The first tranche of $5 million was received in 1Q18 and the second tranche of $5 million is due to be received in 3Q18.
MT-3724

MT-3724 (an ETB targeting CD20) is in an ongoing Phase Ib expansion study intended to better define the single agent overall response rate in heavily pre-treated diffuse large B-cell lymphoma (DLBCL) patients with additional updates expected in 2Q18.
Molecular also expects to initiate Phase II combination studies with MT-3724 in earlier lines of DLBCL in 2H18.
MT-4019

MT-4019 (an ETB candidate designed to target CD38-expressing myeloma cancer cells) is progressing through IND enabling studies.
Takeda and Molecular are evaluating CD38 ETBs and could potentially select a drug candidate for development by the end of 3Q18. If the two companies do not select a joint candidate for development, Molecular anticipates filing an IND application for MT-4019 in 3Q18 and initiating a Phase I clinical trial in 2H18.
Research

Molecular expects to file an IND application for an ETB targeting HER2 in 4Q18.
Molecular expects to file an IND application for an ETB targeting PD-L1 (with antigen seeding) in 1Q19.
Several other ETB candidates are in pre-clinical development, targeting both solid and hematological cancers.
Takeda Multi-Target Collaboration

In December 2017, Takeda selected two targets for further research using Molecular’s ETBs. This triggered $4 million in milestone payments, which were paid by Takeda in 2Q18.
Financial Results

The net loss attributable to common shareholders for the first quarter was $8.7 million, or $0.32 per basic and diluted share. This compares with a net loss attributable to common shareholders of $1.6 million, or $7.56 per basic and diluted share for the same period in 2017.

Revenues for the first quarter of 2018 were $0.5 million, compared to $1.9 million for the same period in 2017. Revenues for the first quarter of 2018 and 2017 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 first quarter of 2018 were $6.7 million, compared with $1.1 million for the same period in 2017. Total general and administrative expenses for the first quarter of 2018 were $2.9 million, compared with $1.8 million for the same period in 2017.

On May 14, 2018 Unum Therapeutics Inc. (NASDAQ: UMRX), a clinical-stage biopharmaceutical company focused on the development of cellular immunotherapies based on its novel, universal Antibody-Coupled T-cell Receptor (ACTR) technology platform, reported financial results and provided a corporate update for the first quarter ended March 31, 2018 and recent activities (Press release, Unum Therapeutics, MAY 14, 2018, View Source [SID1234526563]).

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"Following our successful initial public offering in April 2018 and concurrent private placement, we are in a strong financial position to continue developing our proprietary, universal ACTR technology platform and rapidly advancing our pipeline of cellular immunotherapies through clinical development," said Chuck Wilson, CEO of Unum. "We are currently evaluating the potential of ACTR in combination with different tumor-targeting antibodies, in three ongoing multi-center Phase I trials, ATTCK-20-2 and ATTCK-20-03 evaluating ACTR087 and ACTR707, respectively, in combination with rituximab in patients with CD20+ r/r Non-Hodgkin Lymphoma (NHL), and ATTCK-17-01 evaluating ACTR087 in combination with SEA-BCMA in patients with r/r multiple myeloma. We expect to report preliminary data from these three trials late this year. In the second half of 2018 we also look forward to filing an IND and initiating clinical development of ACTR707 in combination with trastuzumab for the treatment of patients with HER2+ advanced cancers, our first solid tumor product candidate."

Recent Business Highlights and Outlook

Successfully Completed IPO and Concurrent Private Placement: In April, 2018, Unum successfully completed an initial public offering (IPO) of 5,985,000 shares of common stock at a public offering price of $12.00 per share, including the exercise by the underwriters of 215,000 shares of their overallotment option, raising $66.8 million in net proceeds. In addition, with a private placement concurrent with the IPO, Seattle Genetics, Inc. purchased $5.0 million shares of common stock at the initial public offering price. The proceeds from the IPO and the concurrent private placement will be used primarily to advance Unum’s four lead ACTR development candidates.

Initiated Cohort Expansion Phase of ATTCK-20-2 Phase I trial; Plans to Expand Clinical Development: In May 2018, Unum initiated the cohort expansion phase of the ATTCK-20-2 trial evaluating safety and anti-lymphoma activity of ACTR087 at the preliminary recommended phase 2 dose (RP2D) level used in combination with rituximab in patients with CD20+ r/r NHL. Unum expects to report updated data, including preliminary data from this phase of the ATTCK-20-2 trial, in the fourth quarter of 2018.

These data will also inform the strategy for a planned multi-center Phase II clinical trial exploring ACTR T cells used in combination with rituximab in patients with CD20+ r/r NHL who received prior CD19 CAR T cell therapy.

In addition, Unum intends to file a protocol amendment to the ATTCK-20-2 trial in the second half of 2018 to explore ACTR087 in combination with an alternative rituximab dosing regimen from that currently being studied. Preclinical experiments have shown that the level of ACTR T cell activity depends upon the amount of the co-administered antibody. As such, ACTR087 safety and anti-tumor activity in combination with rituximab in CD20+ r/r NHL may be even further optimized by an alternative rituximab regimen. Testing the alternative regimen will complement the clinical data being generated to support additional clinical trials with the combination.

Initiated Patient Enrollment and Dosing in ATTCK-17-01 Phase I trial: In the first quarter, Unum initiated patient enrollment ATTCK-17-01, a Phase I, multi-center, open-label clinical trial designed to test the safety, tolerability, and anti-myeloma activity of ACTR087 used in combination with SEA-BCMA in patients with r/r multiple myeloma. Unum is currently enrolling and dosing patients in this trial and expects to report preliminary data in the fourth quarter of 2018.

Continued Enrollment in ATTCK-20-03 Phase I trial: In the fourth quarter of 2017, Unum initiated patient enrollment in a Phase I, multi-center, open-label clinical trial called ATTCK-20-03, evaluating the safety, tolerability, and anti-lymphoma activity of ACTR707 used in combination with rituximab in patients with CD20+ r/r NHL. Unum has completed enrollment in the first dose level of this ongoing dose escalation study and expects to report preliminary data from the trial in the fourth quarter of 2018.

On Track to File IND for First Solid Tumor ACTR Product Candidate in the Second Half of 2018: Unum is on track to file an IND in the second half of 2018 for ACTR707 in combination with trastuzumab for the treatment of patients with HER2+ advanced cancers.
First Quarter 2018 Financial Results

Collaboration Revenue: Collaboration revenue recognized during the three months ended March 31, 2018 and 2017 of $2.2 million and $1.8 million, respectively, reflects the recognition of a portion of the $25.0 million upfront payment received from Seattle Genetics under Unum’s collaboration agreement as well as reimbursements of research and development costs by Seattle Genetics. Effective January 1, 2018, Unum adopted the new revenue recognition standard, ASC 606, which changed the manner in which the Company recognizes revenue from this collaboration agreement.

R&D Expenses: Research and development expenses were $8.1 million for the three months ended March 31, 2018, compared to $7.0 million for the same period last year. The increase reflects higher clinical trial costs for the three active Phase I clinical trials, as well as increased personnel-related costs, materials and facility-related costs related to scaling manufacturing processes, and increased consultant costs. This was partially offset primarily by a decrease in consulting and manufacturing costs incurred for the Phase I clinical trial of ACTR087 in combination with rituximab as there was no production activity in the first quarter of 2018.

G&A Expenses: General and administrative expenses for the three months ended March 31, 2018 were $1.1 million, compared to $0.9 million for the prior year period.

Net Loss: Net loss attributable to common stockholders was $6.8 million, or $0.66 per share, for the three months ended March 31, 2018, and $6.0 million, or $0.58 per share, for the three months ended March 31, 2017.

Cash, Cash Equivalents and Marketable Securities: As of March 31, 2018, Unum had cash, cash equivalents, and marketable securities of $32.4 million. This amount does not include the approximately $66.8 million in net proceeds from its IPO in April 2018, $5.0 million from the concurrent private placement, and available borrowings under its loan and security agreement of $15.0 million. The Company believes that the net proceeds from the IPO and concurrent private placement, together with its existing cash, cash equivalents, and marketable securities, will fund operating expenses and capital expenditure requirements through at least December 2019, without considering available borrowings under its loan and security agreement.

On May 14, 2018 Mustang Bio, Inc. ("Mustang") (NASDAQ:MBIO), a Fortress Biotech (NASDAQ:FBIO) Company focused on the development of novel immunotherapies based on proprietary chimeric antigen receptor engineered T cell (CAR-T) technology, reported financial results for the first quarter ended March 31, 2018 (Press release, Mustang Bio, MAY 14, 2018, View Source [SID1234526588]).

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Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, "In the first quarter of 2018, Mustang continued to execute on our strategy of developing a portfolio of differentiated CAR-T therapies for patients with aggressive forms of cancer. We are pleased to report significant progress on the build-out of our proprietary CAR-T cell processing facility at UMass Medicine Science Park in Worcester, Mass., which is on track to be fully operational and ready to process cells by the end of the year. We are also transitioning two preclinical CAR-T programs at City of Hope into the clinic in 2018, and plan to file our first Investigational New Drug Application during the fourth quarter. In March, we were delighted to announce the promotion of Sadik Kassim, Ph.D., to Chief Scientific Officer, and Knut Niss, Ph.D., to Chief Technology Officer, and look forward to continuing to work together to innovate in cell processing and to explore opportunities to leverage best-in-class science to strengthen our CAR-T pipeline. To this end, we will expand our internal research capabilities and plan to hire a team of scientists that will be fully dedicated to preclinical and translational research efforts."

Financial Results:

As of March 31, 2018, Mustang’s consolidated cash, cash equivalents, short-term investments (certificates of deposit) and restricted cash totaled $55.3 million, compared to $61.5 million as of December 31, 2017, a decrease of $6.2 million for the quarter.
Research and development expenses were $4.3 million for the first quarter of 2018, compared to $0.7 million for the first quarter of 2017. Non-cash, stock-based compensation expenses included in research and development were $1.5 million for first quarter of 2018, compared to $0 million for the first quarter of 2017.
Research and development expenses from license acquisitions totaled $0.1 million for the first quarter of 2018, compared to $0.6 million for the first quarter of 2017.
General and administrative expenses were $2.1 million for the first quarter of 2018, compared to $2.0 million for the first quarter of 2017. Non-cash, stock-based compensation expenses included in general and administrative expenses were $0.5 million for the first quarter of 2018, compared to $1.2 million for the first quarter of 2017.
Net loss attributable to common stockholders was $6.3 million, or $0.24 per share, for the first quarter of 2018, compared to $3.2 million, or $0.14 per share, for the first quarter of 2017.