On August 12, 2019 Unum Therapeutics Inc. (NASDAQ: UMRX), a clinical-stage biopharmaceutical company focused on developing curative cell therapies for cancer, reported financial results and corporate updates for the second quarter ended June 30, 2019, and provided recent activities (Press release, Unum Therapeutics, AUG 12, 2019, View Source [SID1234538624]).

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"During the quarter, we advanced our preclinical and clinical pipeline programs that are designed to improve the targeting and functionality of T cells to expand their use in hematologic and solid tumor cancers," said Chuck Wilson, President and Chief Executive Officer of Unum. "Today, we reported preliminary results from Cohort 3 of the Phase 1 trial with ACTR707 in patients with relapsed or refractory non-Hodgkin lymphoma. We are very encouraged by the results from this trial that support our progress towards developing a competitive program with complete responses achieved in five of the 14 patients treated and no reported adverse events of cytokine release syndrome or severe neurotoxicity. Patient enrollment in Cohort 4 is now complete and we anticipate providing results from this cohort later this year. Our ACTR and BOXR platform initiatives in solid tumors also continued during the quarter, with Phase 1 trial enrollment activities progressing on our ACTR707 program in patients with HER2+ solid tumors. Our BOXR platform is designed to improve the functionality of engineered T cells by incorporating a "bolt-on" transgene to overcome resistance of the solid tumor microenvironment to T cell attack, and we are pleased to advance our first candidate from this platform, BOXR1030, towards clinical trials."

Recent Program and Corporate Highlights

ACTR707 Hematologic Program Highlights:

Preliminary results from Cohort 3 from the Phase 1 trial (ATTCK-20-03) in non-Hodgkin lymphoma: Today, Unum provided preliminary results from patients treated in Cohort 3 in ATTCK-20-03, a Phase 1, multicenter, open-label, single-arm, dose-escalating trial evaluating ACTR707 in combination with rituximab in patients with relapsed/refractory CD20+ B cell non-Hodgkin lymphoma (r/r NHL) who, among other criteria, received adequate prior anti-lymphoma therapy, including anti-CD20 monoclonal antibody and chemotherapy. Among the 14 patients treated in Cohorts 1, 2 and 3, the majority (93%) were diagnosed with diffuse large B-cell lymphoma (DLBCL) and were heavily pre-treated with 57% having received three or more prior lines of therapy. Previously, results from the six patients treated in Cohort 1 (25M ACTR707+ T cells) and the three patients treated in Cohort 2 (40M ACTR707+ T cells) were presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2018. As presented at ASH (Free ASH Whitepaper), complete responses were achieved in three of six patients (50%) from Cohort 1 and a complete response was achieved in one of three (33%) patients from Cohort 2. The overall response rate, including complete and partial responses, was 50% in Cohort 1 and 67% in Cohort 2.

As a preliminary update provided today, for the five patients treated in Cohort 3 (55M ACTR707+ T cells), a complete response was achieved in one of five patients (20%) with overall responses in four of five patients (80%). The overall responses achieved in this cohort included evidence of deepening responses in two patients whose stable disease improved after the initial response assessment at day 42 to a partial and a complete response, respectively, as of the data cutoff in May 2019 (Table 1).
Table 1: ACTR707 Preliminary Phase 1 trial efficacy results in r/r NHL (Cohorts 1-3)
Clinical Response (1) Cohort 1
(n=6) Cohort 2
(n=3) Cohort 3
(n=5) Cohorts 1-3
(n=14)

Complete Response 3 1 1 36% (5/14)
Partial Response 0 1 3 29% (4/14)
Indeterminate Response 1 0 0 7% (1/14)
Progressive Disease 2 1 1 29% (4/14)
Overall Response Rate 50% (3/6) 67% (2/3) 80% (4/5) 64% (9/14)
ACTR707 + T cells administered per patient (range) 25M (23-38M) 40M (30-50M) 55M (45-55M)
(1) Data cutoff as of May 2019

Durable responses were observed in patients achieving a complete response with the durability of response ranging from 85-387+ days. In the first three cohorts, ACTR707 was well-tolerated in combination with rituximab. No dose-limiting toxicities (DLTs), no adverse events of cytokine release syndrome (CRS), and no severe neurological adverse events including neurotoxicity have been reported in Cohorts 1, 2 and 3 as of the May 2019 cutoff. Serious adverse events that were assessed by the investigator as possibly related to ACTR707 include two cases of febrile neutropenia and one case of cytopenia in Cohorts 1 and 2 (Table 2).

Table 2: ACTR707 Preliminary Phase 1 trial safety results in r/r NHL (Cohorts 1-3)

Safety Event (1) Cohort 1
(n=6) Cohort 2
(n=3) Cohort 3
(n=5)
Dose-limiting toxicities 0 0 0
Severe neurologic events (> Grade 3) 0 0 0
CRS (any grade) 0 0 0
ACTR707-related SAEs 1 2 0
febrile neutropenia 1 1 0
cytopenia 0 1 0
(1) Data cutoff as of May 2019

Cohort 4 (80M ACTR707+ T cells) enrollment proceeding in ATTCK-20-03: Enrollment in Cohort 4 of ATTCK-20-03 is complete and Unum plans to report updated results from ATTCK-20-03, including data from patients in Cohort 4, in late 2019.
ACTR707 Solid Tumor Program Highlights:

Phase 1 trial (ATTCK-34-01) with ACTR707 in HER2+ advanced solid tumor cancers ongoing: Clinical trial site activation, patient identification, screening and enrollment continues in the first dose cohort of ATTCK-34-01, a Phase 1, multicenter, open-label, single-arm, dose-escalation trial evaluating ACTR T cells (ACTR707) in combination with trastuzumab for the treatment of patients with HER2+ advanced cancers. Unum plans to report updates from the ATTCK-34-01 trial including patient enrollment status and preliminary safety data at the end of 2019.

Preclinical data demonstrate that, unlike traditional trastuzumab-based CAR-T cells that target HER2, ACTR707+ T cells administered with trastuzumab are highly selective for HER2-overexpressing tumor cells and discriminate against cells from normal tissues that express low levels of HER2. The preclinical activity of ACTR707+ T cell has been shown to be dose-dependent demonstrating control of ACTR707 activity by modulation of trastuzumab concentration. Together, the preclinical data suggest that ACTR cells in combination with trastuzumab may exhibit an improved clinical therapeutic index.

BOXR Solid Tumor Program Highlights:

Preclinical development ongoing for BOXR1030 targeting GPC3+ advanced cancers: Unum’s Bolt-On Chimeric Receptor (BOXR) platform is designed to improve engineered T cell functionality by identifying and incorporating a "bolt-on" transgene to overcome resistance of the solid tumor microenvironment to T cell attack. BOXR bolt-on transgenes identified in this platform are designed to address a variety of immunosuppressive mechanisms of solid tumors including metabolic competition, immune suppressor cells, and exhaustion due to chronic stimulation. These transgenes could offer the potential to add new functionality to T cells not achievable by traditional small molecule or antibody-based approaches. In addition, the BOXR bolt-on transgenes may be incorporated into several different types of therapeutic T cells, including ACTR T cells and CAR-T cells. Using a variety of BOXR bolt-on transgenes and tumor targeting technologies, Unum is building a pipeline of preclinical candidates to address a diverse range of solid tumor indications.

In early 2019, Unum nominated BOXR1030 as the first product candidate from the BOXR platform. In addition to research to further characterize its mechanism of action, preclinical studies of BOXR1030 are underway to support the filing of an investigational new drug (IND) application for BOXR1030. Unum plans to present preclinical data regarding BOXR1030 in the second half of 2019.
ACTR087 Hematologic Program Highlights:

Dose escalation continuing in Phase 1 (ATTCK-17-01) trial in multiple myeloma: Dose escalation continued during the second quarter in the ATTCK-17-01 trial combining ACTR087 with low doses of SEA-BCMA antibody. Enrollment and dosing of patients is complete in Cohort 4 (30M ACTR087+ T cells and 2.0 mg/kg SEA-BCMA) and Cohort 5 (50M ACTR087+ T cells and 2.0 mg/kg SEA-BCMA). Unum expects to report data from multiple dose cohorts in the second half of 2019.

Treatment continuing for responding patients in Phase 1 (ATTCK-20-2) trial in non-Hodgkin lymphoma: In July 2019, Unum announced that the U.S. Food and Drug Administration (FDA) placed a clinical hold (since communicated by the FDA as a partial clinical hold) on the Phase 1 trial (ATTCK-20-2) evaluating Unum’s ACTR087 in combination with rituximab in patients with CD20+ r/r NHL. The clinical hold was initiated following the submission of a safety report by Unum to the FDA regarding one patient in the safety expansion cohort of the trial who experienced serious adverse events including neurotoxicity, cytomegalovirus infection, and respiratory distress. As an update to this case, this patient subsequently experienced septic shock that was fatal and reported by the investigator as related to ACTR087. Patients who previously received ACTR087 and have ongoing clinical responses continue to receive rituximab infusions, with continued monitoring for adverse events. Unum continues to work closely with the FDA to further review these events and plans to report data from the ATTCK-20-2 trial at the end of 2019.
Corporate Highlights:

Announced new additions to its leadership team including Matthew Osborne as Chief Financial Officer, Mert Aktar as of Head of Business and Corporate Development and Jessica Sachs, M.D., as Chief Medical Officer replacing Michael Vasconcelles, M.D., who transitioned to a clinical advisory role. Each new executive has a proven track record of excellence and adds decades of experience to the Unum leadership team.

Announced the appointments of Arlene Morris and Matthew Ros to its Board of Directors. Ms. Morris and Mr. Ros replaced Robert Perez and Liam Ratcliffe, who transitioned from Unum’s Board of Directors in conjunction with their new positions within the biotechnology industry. Ms. Morris and Mr. Ross bring significant commercial, clinical and operational experience within the oncology field. Ms. Morris brings extensive corporate and business development experience in the pharmaceutical and biotechnology industries from numerous management and board roles, while Mr. Ros adds specific commercial experience, particularly with oncology products.

Entered into an agreement with Harbour Antibodies BV, a wholly-owned subsidiary of Harbour BioMed, granting Unum rights to utilize Harbour Antibodies’ H2L2 Harbour Mice platform. The agreement enables Unum to discover and incorporate fully-human antibody sequences into its novel ACTR and BOXR platforms to further enable and accelerate Unum’s preclinical discovery and development efforts.
Second Quarter 2019 Financial Results

Collaboration Revenue: Collaboration revenue recognized during the second quarter ended June 30, 2019 was $3.1 million, compared to $1.7 million in the same period of 2018. The increase reflects the recognition of a portion of the upfront payment received from Seattle Genetics, Inc. under Unum’s collaboration agreement as well as reimbursements of research and development costs attributed to the collaboration agreement.

R&D Expenses: Research and development expenses were $10.6 million for the second quarter ended June 30, 2019, compared to $9.1 million for the same period of 2018. The increase primarily reflects higher clinical trial costs for the active Phase 1 trials, as well as increased personnel-related costs.

G&A Expenses: General and administrative expenses for the second quarter ended June 30, 2019, were $3.1 million, compared to $2.0 million for the same period of 2018. The increase is primarily related to higher personnel related costs due to increased headcount and increased expenses around operating as a public company.

Net Loss: Net loss attributable to common stockholders was $10.5 million, or $0.34 per share, for the second quarter ended June 30, 2019, and $9.0 million, or $0.31 per share, for the same period of 2018.

Cash and Cash Equivalents: As of June 30, 2019, Unum had cash and cash equivalents of $55.9 million. Unum believes that its existing cash and cash equivalents will fund operating expenses and capital expenditure requirements into early 2021.
Investor Call and Webcast Information

Unum will host a live conference call and webcast today, August 12, 2019, at 4:30 p.m. ET, to discuss these financial results and company updates. To access the call, please dial 866-300-3411 (domestic) or 636-812-6658 (international) and refer to conference ID number 5658375. A webcast will be available at unumrx.com at least 10 minutes before the event begins. The archived webcast will be available at the same location approximately two hours after the event and will be archived for 90 days.

On August 12, 2019 Propanc Biopharma, Inc. (OTC: PPCB) ("Propanc"), a biopharmaceutical company developing new cancer treatments for patients suffering from recurring and metastatic cancer, reported that the company’s scientific researchers, together with its joint research partners, Universities of Jaén and Granada, published key data in a peer reviewed journal, Scientific Reports, confirming the mechanism of proenzymes and its anti-cancer effects against cancer stem cells (CSCs) (Press release, Propanc, AUG 12, 2019, View Source [SID1234538605]). From the publishers of Nature, it is an online, open access journal, which publishes primary research from all areas of the natural and clinical sciences. The article is entitled "Pancreatic proenzymes treatment suppresses BXPC-3 pancreatic Cancer Stem Cell subpopulation and impairs tumor engrafting," and can be accessed via the company website under the link: View Source

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"We are excited to publish this paper on our work with PRP and CSCs, where these cells drive cancer," said Dr Julian Kenyon, Propanc’s Chief Scientific Officer. "We were able to destroy these cells in significant numbers. Remarkably, we observed at least 13 genes that induce cancer were downregulated by PRP. Also, genes implicated in metastasis were downregulated and 7 genes related to cell adhesion, which is the normal state of healthy tissue, were upregulated. In summary, PRP has multiple modes of action, quite unlike any other cancer drug and is clearly in a class of its own. This is likely to translate into PRP being effective in many different cancer types and reducing the recurrence rate after standard treatments."

"Importantly, we proved that PRP impaired engrafting of human derived pancreatic CSC tumors in nude (immune compromised) mice, whilst also displaying an antigrowth effect toward initiated xenografts (grafted, human derived tumors), showing a decreased amount of tumor surrounding fibrotic tissue of treated mice," said Dr. Perán, Acting Professor at the Department of Health Sciences, University of Jaén and Propanc’s Scientific Advisor. "As cancer treatment moves towards more personalized medicine, proven therapies that target and treat specifically CSCs may prove to be a useful method for reducing recurrence after drug treatment failures."

The data provides the strongest evidence that proenzymes could be an effective tool in the fight against metastatic cancer, the single biggest cause of patient death for sufferers. The company’s lead product candidate, PRP, is a formulation of two proenzymes, designed to act synergistically against solid tumors which are malignant. PRP is currently in preparation for a First-In-Human study in advanced cancer patients which the company plans to commence in 2020.

To explain the significance of the discovery, people often have the misconception that tumors are made up from the same type of malignant cell that grows uncontrollably and exponentially. Although that could be the first impression when a tumors progress rapidly, in fact, tumors are a very complicated kind of new organ that develops an intricate organization with its own blood supply and an intricate communication system with the rest of the organism that facilitates the cancer dispersion. In addition, there are different types of cells within a tumor mass, it is true that all of them have a common feature, they are undifferentiated cells, but some of them are more "ancestral" than others. These cells are named cancer stem cells, or CSCs, and are responsible for tumor metastasis and tumor relapse. The strength of these particular cells is that they do not replicate, so conventional therapies that only affect growing cells, do not harm CSCs.

Other important facts about tumors is their ability to change their surroundings, inducing neighboring cells to become malignant, and even more worrisome, its ability to corrupt distant tissue cells creating a future tumor microenvironment.

After more than 10 years collaboration with Propanc’s prestigious, joint scientific researchers with significant experience in cancer, the company now understands the mechanism of action of PRP, a formulation containing a synergistic combination of two pancreatic proenzymes. The "beauty" of this naturally derived formulation is that the body has designed enzymes to perform a specific role on the cells to orchestrate gradual changes. In the same pathways that active enzymes work on healthy cells, PRP, once converted to the activated enzyme form, changes the malignant nature of cancer cells toward a differentiated state in which cells return to be what they were. Some of the company’s scientific studies have already been published in high impact journals, demonstrating that PRP decreases cell proliferation and migration, induces cell differentiation and impairs angiogenesis. In short, tumors cannot grow after PRP treatment, as demonstrated by in vivo studies with mice models.

This latest achievement has demonstrated that PRP also has a significant effect on that population of cells within the tumor that keep a dormant state and a stemness nature. As stated above, those cells, called CSCs, are not eradicated by conventional therapies and are responsible for generating a new tumor in other organs, a process known as metastasis, which is the main cause of patient death for sufferers.

"In collaboration with the Universities of Jaén and Granada, we have performed a detailed study on the effects of PRP upon these tumor-initiating cells and we are excited to reveal that our results are very encouraging," said Mr. James Nathanielsz, Propanc’s Chief Executive Officer. "In addition, we have proven a beneficial impact of our novel treatment, PRP, on tumor initiation and progression as well as on the tumor microenvironment, which is of great scientific interest."

The company has also been working with its research partners with the aim of enhancing the effects of PRP, whilst also maximizing a better-quality and safer product. The project is progressing well and on track to produce an optimized version of PRP which could be effectively reproduced with enhanced effects, compared to the naturally derived proenzymes. Further work is currently being undertaken to ensure the product is comparable in structure to PRP.

About the University of Jaén:

The University of Jaén is among the Top 50 of the best young universities in the world according to THE (Times Higher Education). Likewise, the University of Jaén received the EFQM 500+ European Seal of Excellence, the highest level of recognition awarded by the Excellence in Management Club, as the official representative of the European Foundation for Quality Management (EFQM) in Spain. It also stands out in the field of computing, since the University of Jaén is among the 75 best universities in the world, according to Academic Ranking of World Universities (ARWU) 2017. The University of Jaén is repeatedly in the top 4% of universities worldwide, according to the Ranking Center for World University Rankings (CWUR), which annually collects the thousand best and most valued among the more than 25,000 existing universities. In addition, it is the fourth Spanish university that has obtained the highest score in the ranking of international student satisfaction, published by the STEXX International Studyportals Organization, in its 2016 version.

About the University of Granada:

The University of Granada is widely recognized internationally for its quality in higher education, teaching, research and outreach. National and international rankings reflect the University Granada’s position among the top universities in Spain and among the best in the world. In 2018, the University of Granada has further consolidated this dominant position – taking 278th place in the world and 3rd in Spain in the recently published Shanghai Academic Ranking of World Universities (ARWU 2018). Viewed from the perspective of its performance in specific academic subjects, the UGR has also set a new record, with a further 34 subjects taught at the University featuring in the 2018 ARWU — 12 more than in 2017. Furthermore, 5 of the University Granada’s subjects feature among the world top 100, marking another significant milestone.

On August 12, 2019 Molecular Templates, Inc. (Nasdaq: MTEM, "Molecular," "Molecular Templates" or "MTEM"), a clinical-stage biopharmaceutical 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 second quarter of 2019. As of June 30, 2019, MTEM’s cash and investments totaled $72.3 million, and is expected to fund operations into the first half of 2021 (Press release, Molecular Templates, AUG 12, 2019, View Source [SID1234538626]).

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"Updated data from our Phase I/Ib study of MT-3724 in DLBCL continue to show promising activity in heavily pretreated patients. In our three ongoing Phase II studies with MT-3724, we hope to replicate the monotherapy activity in a larger patient population as well as show the utility and safety of combination dosing in the separate chemotherapy and Revlimid combination studies," said Eric Poma, Ph.D., Molecular Templates’ Chief Executive and Scientific Officer. "Investigational New Drug Applications (INDs) have been accepted for both MT-5111 (HER2 targeted ETB) and TAK-169 (CD38 ETB) with Phase I dosing expected to begin soon for both programs. We look forward to providing study updates on the three ongoing MT-3724 Phase II studies and the MT-5111 Phase I study by the end of the year."

Company Highlights and Upcoming Milestones

TAK-169

Takeda and MTEM announced the acceptance of the IND for TAK-169 (CD38 targeted ETB) in June 2019. Dosing in the trial is expected to start in 2H19.
As presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in April 2019, TAK-169 is more potent than MT-3724 (our CD20 targeted ETB) and was also well tolerated at much higher doses than was MT-3724 in non-human primates.
The starting dose for the dose escalation for TAK-169 is 50 mcg/kg, which is the MTD for MT-3724. The protocol includes once weekly and once every two-week dosing schedules.
MT-3724

The Phase I/Ib monotherapy study of MT-3724 completed enrollment in 1Q19. Final data from this study are expected to be presented at a medical conference. A total of 27 patients were treated in this study across a range of doses (5 mcg/kg-100mcg/kg); 50 mcg/kg was identified as the maximum tolerated dose (MTD).
Thirteen of these patients with diffuse large B-cell lymphoma (DLBCL) were relapsed/refractory DLBCL patients (including transformed and composite histology), with assay-negative levels of serum rituximab.
Results for these thirteen patients were:
Five patients had responses (1 complete response, 1 complete metabolic response, 3 partial responses) for a 38% response rate. The median number of prior therapies in the responders was 3; four of the responders were primary R-CHOP refractory.
Three patients had stable disease (including two patients with 49% and 47% tumor reductions).
Five patients had progressive disease.
Five of these thirteen patients were treated at the MTD of 50 mcg/kg. Three of these five patients responded (1 CR, 2 PRs).
The patient with a CR has left the study for personal reasons after 5 cycles while still in a complete response.
One of the other patients with a PR remains in response and is currently in their 9th cycle of dosing.
The remaining patient, who had heterogeneous CD20 status at enrollment, had a partial response and then progressed after approximately 5 cycles.
The 50 mcg/kg dose has been generally well-tolerated; no life-threatening toxicities have been observed at any dose of MT-3724.
MTEM is conducting a Phase II monotherapy study of MT-3724 in relapsed/refractory DLBCL. This study has the potential to serve as a registration study. MTEM expects to provide an update on this study in 4Q19.
MTEM is also conducting two Phase II studies in earlier lines of DLBCL; one with MT-3724 in combination chemotherapy (gemcitabine and oxaliplatin) and the other with MT-3724 in combination with Revlimid. The Company expects to report an update on both MT-3724 combination studies in 4Q19.
MT-5111

MTEM announced the acceptance of its IND filing for MT-5111, its ETB targeting HER2, in April 2019. The Phase I study in patients with HER2 positive solid tumors is expected to start dosing in 3Q19. MTEM expects to report an update on this study in 4Q19.
Research

MTEM expects to file an IND application for MT-6035, its ETB targeting PD-L1 (with antigen seeding), in 4Q19.
Several other ETB candidates are in preclinical development, targeting both solid and hematological cancers.
Takeda Multi-Target Collaboration

Takeda and MTEM 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, MTEM would receive $25.0 million and would be eligible to receive up to $547.0 million in milestone payments and tiered royalties on sales.
Financial Results

The net loss attributable to common shareholders for the second quarter of 2019 was $9.2 million, or $0.25 per basic and diluted share. This compares with a net loss attributable to common shareholders of $9.7 million, or $0.36 per basic and diluted share, for the same period in 2018.

Revenues for the second quarter of 2019 were $5.4 million, compared to $1.4 million for the same period in 2018. Revenues for the second quarter of 2019 were comprised of revenues from collaborative research and development agreements with Takeda, and grant revenue from CPRIT. Total research and development expenses for the second quarter of 2019 were $10.2 million, compared with $7.7 million for the same period in 2018. Total general and administrative expenses for the second quarter of 2019 were $4.6 million, compared with $3.7 million for the same period in 2018.

On August 12, 2019 Apollo Endosurgery, Inc. ("Apollo") (Nasdaq:APEN), a global leader in less invasive medical devices for gastrointestinal and bariatric procedures, reported that it has closed its previously announced private placement of $20 million of unsecured convertible debentures to accredited and institutional investors (Press release, Lpath, AUG 12, 2019, View Source [SID1234538836]).

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Interest on the debentures is payable semi-annually in common stock, or in kind in certain situations, at a rate per annum of 6.0%. At any time prior to maturity, the debentures are convertible into shares of Apollo’s common stock at a conversion price of $3.25, subject to certain customary adjustments. Upon the satisfaction of price and other conditions, Apollo has the right to force the conversion of the debentures. The debentures are unsecured and rank junior in right of payment to Apollo’s existing senior indebtedness. The outstanding principal and accrued interest on the debentures is due on the five-year anniversary of the issuance date. Apollo intends to use the proceeds from the sale of debentures for working capital and general corporate purposes.

Craig-Hallum Capital Group acted as the exclusive placement agent in connection with this transaction.

The securities sold in the private placement have not been registered under the Securities Act of 1933, as amended, or state securities laws and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission (SEC) or an applicable exemption from such registration requirements. Apollo has agreed to file a registration statement with the SEC registering the resale of the shares of common stock underlying the convertible debentures.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful.

On August 12, 2019 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, reported financial results for the second quarter ended June 30, 2019, and provided a corporate update (Press release, Cellectar Biosciences, AUG 12, 2019, View Source [SID1234538589]).

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"We made considerable progress on both the clinical and regulatory fronts during the second quarter and subsequent period. CLR 131 continues to advance, delivering encouraging preliminary data with improving efficacy and a clear dose response in our ongoing Phase 1 study. In addition, the company received FDA Fast Track Designation for CLR 131 in two separate indications and believe that we continue to track toward a registrational study in at least one B-cell hematologic malignancy from our ongoing Phase 2 CLOVER-1 study," said Jim Caruso, CEO of Cellectar. "Our recently adopted fractionated dosing schedule of CLR 131 has led to the improved efficacy and tolerability observed in our latest cohorts and we are moving forward with this dosing strategy in our recently initiated pediatric Phase 1 trial for the treatment of life-threatening cancers."

Second Quarter and Recent Corporate Highlights

·Announced initial results from Cohort 6 in the company’s ongoing Phase 1 clinical study with CLR 131 in Relapsed or Refractory Multiple Myeloma (R/R MM). Data from Cohort 6 showed improved efficacy and a clear dose response compared to prior cohorts, including a 50% overall response rate, a 50% minimal response rate and 100% disease control rate. The International Myeloma Working Group defines a partial response as a 50% to 89.9% reduction in the marker of disease and minimal response as 25% to 49.9% reduction in the marker of disease. One patient achieved a minimal response with a 48% reduction in their m-protein. The other patient achieving a minimal response had a 39% reduction in m-protein remains on study and continues to be evaluated.

·Expanded the third cohort of our ongoing Phase 2 CLOVER-1 study of CLR 131 after preliminary results showed it exceeded pre-specified performance criteria. We are currently enrolling patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), lymphoplasmacytic lymphoma (LPL) and marginal zone lymphoma (MZL) in the third cohort. The company continues to expect to report top-line data from the Phase 2 CLOVER-1 study in 2019.

·Received FDA Fast Track Designation for CLR 131 in two separate indications: in fourth line or later relapsed/refractory multiple myeloma and in relapsed or refractory Diffuse Large B-Cell Lymphoma (DLBCL). CLR 131 is currently being evaluated in Cellectar’s ongoing CLOVER-1 Phase 2 clinical study in patients with select B-Cell lymphomas, including multiple myeloma and DLBCL.

·Closed on a financing for gross proceeds of $10 million. In a registered direct offering, Cellectar issued 1,982,000 shares of common stock. In a separate concurrent private placement transaction, Cellectar sold 2,018,000 shares of common stock. In conjunction with the offerings, the company also issued 4,000,000 warrants to purchase common stock in the private placement.

Second Quarter Summary of Financial Results

Cash and Cash Equivalents: As of June 30, 2019, cash and cash equivalents were approximately $16.8 million compared to $13.3 million as of December 31, 2018. We believe that our cash balance is adequate to fund our basic budgeted operations through the fourth quarter of 2020. Cash used in operating activities was approximately $5.5 million during the six months ended June 30, 2019 as compared to $5.7 million used during the six months ended June 30, 2018.

Research and Development Expense: R&D expense for the three months ended June 30, 2019 was $1.8 million compared to $1.7 million in the three months ended June 30, 2018. The cumulative R&D spending for the first six months of 2019 was $4.1 million as compared to $3.8 million for the first six months of 2018. The majority of the company’s R&D spend for year-to-date 2019 was dedicated to the start-up and support of our pediatric study with $1.3 million and $2.9 million spent for the three and six months ending June 30, 2019, respectively, related to clinical project costs and manufacturing expenses.

General and Administrative Expense: General and administrative (G&A) expense for the three months ended June 30, 2019 was approximately $1.4 million compared to approximately $1.2 million in the three months ended June 30, 2018. The cumulative G&A spending for the first six months of 2019 were of $2.7 million as compared to $2.6 million for the first six months of 2018.

Net Loss: Net loss for the three months ended June 30, 2019 was $(3.2) million, or a loss of $(0.46) per diluted share, compared to a net loss of $(2.9) million, or a loss of $(1.69) per diluted share, in the three months ended June 30, 2018. Net loss for the six months ended June 30, 2019 was $(6.8) million, or a loss of $(1.15) per diluted share, compared to a net loss of $(6.4) million, or a loss of $(3.75) per diluted share, in the six months ended June 30, 2018.

About CLR 131

CLR 131 is a small-molecule, targeted Phospholipid Drug Conjugate (PDC) designed to deliver cytotoxic radiation directly to cancer cells, while limiting exposure to healthy cells. CLR 131 is the company’s lead product candidate and is currently being evaluated in a Phase 2 study in B-Cell lymphomas, and two Phase 1 dose-escalating clinical studies, one in multiple myeloma and one in pediatric solid tumors and lymphoma. CLR 131 was granted Orphan Drug designation for the treatment of multiple myeloma, and was granted Orphan Drug and Rare Pediatric Disease designations for the treatment of neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma and osteosarcoma.