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SELLAS Life Sciences Reports Full Year 2019 Financial Results and Provides Business Update

On March 13, 2020 SELLAS Life Sciences Group, Inc. (Nasdaq: SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, reported financial results for the year ended December 31, 2019 and provided a business update (Press release, Sellas Life Sciences, MAR 13, 2020, View Source [SID1234555533]).

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"Our clinical and corporate progress in 2019 has laid the foundation for a busy and exciting 2020. We are progressing our clinical development program for galinpepimut-S (GPS), including our Phase 3 REGAL study in acute myeloid leukemia (AML), our Phase 1/2 basket study in combination with pembrolizumab (KEYTRUDA), and our Phase 1 trial in combination with nivolumab (Opdivo) in malignant pleural mesothelioma (MPM). The positive follow-up data of the Phase 2a AML CR2 study announced last month further support our Phase 3 REGAL study design," said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. "Additionally, we have received and incorporated feedback from the U.S. Food and Drug Administration (FDA) on the design and plan for a Phase 3 registration-enabling study of nelipepimut-S (NPS) in patients with triple negative breast cancer (TNBC). Coupled with the Phase 2b data for NPS in combination with pembrolizumab in TNBC patients that were recently published in Clinical Cancer Research, this supports our business development efforts to pursue out-licensing opportunities for NPS’ clinical development."

Recent Pipeline Highlights

Galinpepimut-S (GPS) Program

In February 2020, SELLAS announced positive follow-up data from its Phase 1/2 study of GPS in patients with AML in second complete remission (CR2). The final data show a median overall survival (OS) of 21.0 months, at a median follow-up of 30.8 months, in patients receiving GPS compared to 5.4 months in patients treated with best standard care (p-value < 0.02). GPS therapy continued to be well-tolerated throughout the study.
In February 2020, SELLAS announced the enrollment of the first patient in an investigator-sponsored clinical trial of GPS in combination with Bristol-Myers Squibb’s anti-PD-1 therapy, nivolumab (Opdivo), in patients with MPM.
In January 2020, SELLAS announced that it has commenced patient screening for its pivotal Phase 3 REGAL study of GPS in patients with AML in CR2.

Nelipepimut-S (NPS) Program

Today, SELLAS is announcing that final results from the efficacy and safety data analysis of the Phase 2b independent investigator-sponsored clinical trial of the combination of trastuzumab (Herceptin) +/- NPS targeting HER2 low-expressing breast cancer patient cohorts, including TNBC patients, were recently published in the peer reviewed journal, Clinical Cancer Research. With regard to the TNBC patient cohort, the data analysis shows:
º Disease-free survival (DFS) landmark rate at 24 months for patients treated with NPS plus trastuzumab (n=53) was 92.6% compared to 70.2% for those treated with trastuzumab alone (n=44), a clinically and statistically significant improvement.
º There was a statistically significant reduction of 71.9% (p=0.01) in the frequency of clinically detected recurrences in patients treated with the combination (NPS plus trastuzumab) versus trastuzumab alone.
º The combination was generally well-tolerated and there were no clinicopathologic differences between the study groups.
In February 2020, SELLAS announced it finalized the design and plan for a Phase 3 registration-enabling study of NPS in combination with trastuzumab for the treatment of patients with TNBC in the adjuvant setting after standard treatment, following feedback from a Type C review with the FDA. SELLAS is actively pursuing out-licensing opportunities to fund and conduct the future clinical development of NPS.
Recent Corporate Highlights

In February 2020, SELLAS announced the appointment of Dragan Cicic, MD, as Senior Vice President, Clinical Development.
In January 2020, SELLAS entered into a securities purchase agreement with institutional investors to purchase approximately $6.5 million of its common shares (or pre-funded warrants to purchase common shares in lieu thereof) in a registered direct offering priced at-the-market and warrants to purchase common shares in a concurrent private placement.
Year End 2019 Financial Results

Cash Position: As of December 31, 2019, cash and cash equivalents were $7.3 million, compared to $5.3 million as of December 31, 2018. Net cash used in operating activities was $17.6 million for the year ended December 31, 2019, compared to $30.4 million for the year ended December 31, 2018. Net cash provided by financing activities was $19.6 million for the year ended December 31, 2019, primarily attributable to $16.0 million in net proceeds from the sale of equity securities and $3.6 million in net proceeds from the exercise of warrants to acquire shares of common stock. For the year ended December 31, 2018, net cash provided by financing activities was $23.1 million, primarily attributable to $31.2 million in net proceeds from the sale of equity securities, partially offset by $7.6 million in principal payments on previously outstanding debt and $0.5 million in cash dividends paid to the holders of previously outstanding preferred stock.

R&D Expenses: Research and development expenses were $7.3 million for the year ended December 31, 2019, as compared to $8.8 million for the year ended December 31, 2018. The $1.5 million decrease was primarily due to a $1.0 million decrease in personnel related expenses due to decreased headcount, a $0.6 million decrease in licensing fees primarily due to a clinical milestone for GPS recognized in 2018, a $0.3 million decrease in clinical expenses due to the completion of the Phase 2b trial of NPS in combination with trastuzumab in 2018 and a $0.2 million decrease in other research and development expenses. These decreases were partially offset by a $0.6 million increase in manufacturing related expenses for GPS.

G&A Expenses: General and administrative expenses were $9.9 million for the year ended December 31, 2019, as compared to $12.8 million for the year ended December 31, 2018. The $2.9 million decrease was primarily driven by a $0.8 million decrease in outside services and public company costs, a $0.7 million decrease in legal fees, a $0.7 million decrease in personnel related expenses due to reduced headcount, a $0.4 million decrease in rebates and returns related to former commercial products, a $0.2 million decrease in accounting fees, and a $0.3 million decrease in other general and administrative expenses. These decreases during 2019 reflect the Company’s efforts to limit expenses in order to preserve capital. These decreases were partially offset by a $0.2 million increase in insurance premiums.

Net Loss: Net loss for the year ended December 31, 2019 was $19.3 million and loss attributable to common stockholders was $28.0 million, or a basic and diluted loss per share to common stockholders of $10.92, as compared to a net loss of $27.7 million and loss attributable to common stockholders of $41.3 million for the year ended December 31, 2018, or a basic and diluted loss per share to common stockholders of $157.72. Net loss and loss attributable to common stockholders for the year ended December 31, 2019 includes a $2.8 million one-time non-cash impairment charge of in-process research and development associated with the abandonment of future development of GALE-301 and GALE-302, cancer immunotherapies that target the E39 peptide derived from the folate binding protein, as they are outside of the Company’s core focus of the development of GPS. Net loss and loss attributable to common stockholders for the year ended December 31, 2018 includes a $9.6 million one-time non-cash impairment charge of in-process research and development associated with the termination of a license agreement for anagrelide CR formulation (GALE-401).

Keytruda and Herceptin are registered trademarks of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., USA, and Genentech, Inc., respectively, and are not trademarks of SELLAS. The manufacturers of these brands are not affiliated with and do not endorse SELLAS or its products.

Clarity Pharmaceuticals Signs Copper-67 Supply Agreement with Idaho State University’s Idaho Accelerator Center

On March 13, 2020 Clarity Pharmaceuticals, a radiopharmaceutical company focused on the treatment of serious disease, is reported the signing of a Product Supply Agreement with the Idaho State University Idaho Accelerator Center (IAC) for the production and commercial supply of copper-67 (Cu-67) (Press release, Clarity Pharmaceuticals, MAR 13, 2020, View Source [SID1234555497]).

Under the new agreement, IAC will supply Clarity with Cu-67 for planned clinical development, including the SARTATETM trial in children with neuroblastoma and SAR-bisPSMA trial in prostate cancer patients in the United States. IAC has been Clarity’s long-term partner, providing a reliable supply of high purity and high specific activity Cu-67 for some years. IAC’s proven experience in the production and supply of Cu-67 has already allowed Clarity to initiate and complete therapeutic studies in a range of cancer types both in the United States and in Australia.

Clarity’s Executive Chairman, Dr Alan Taylor, commented, "We are excited to bolster our relationship with IAC to further progress our pipeline of theranostic agents in the fight against cancer. IAC’s electron accelerator capability enables Clarity to eliminate the reliance on supply from the limited number of aging nuclear reactors which currently produce therapeutic radionuclides such as lutetium-177. This gives Clarity the opportunity to move swiftly through clinical trials with its three main products, SARTATETM, SAR-bisPSMA and SAR-BBN in such indications as neuroblastoma, neuroendocrine tumours, prostate cancer, breast cancer and brain cancers.

"We are pleased to have signed the Product Supply Agreement with Clarity and are looking forward to continuing our supply of this copper isotope using our increased capacity and our world leading e-linac process to produce a high purity product at very high specific activity," said Jon Stoner, director of the IAC. "Clarity’s proprietary chelator technology along with our patent protected commercially produced Cu-67 combine to showcase a future market leading medical isotope."

Dr Taylor further commented, "Clarity is a clinical stage radiopharmaceutical company that is uniquely placed to control its full supply chain within the United States. With IAC further planning on additional facilities to support the development of Cu-67 production and with Clarity having recently signed a Letter of Intent with NorthStar Medical to supply and industrialise the production of this therapeutic isotope, we are well underway towards building stable and reliable commercial-scale supply of Cu-67 for our late-phase trials and market entry of our products in a number of large cancer indications".

About Copper-67 (Cu-67)
Copper-67 (Cu-67) is a short-range, beta-emitting radioisotope which is attractive for medical purposes due to its ability to carry sufficient radiation energy to cause cell death in targeted cells while having a sufficiently short half-life to limit unwanted radioactivity in patients. Cu-67 is being investigated for therapeutic purposes across a wide range of adult and childhood cancers. Potential radiotherapeutic targets include prostate cancer, breast cancer, neuroendocrine tumours (NETs), neuroblastoma, glioma, lymphoma, ovarian cancer and bladder cancers. In order to develop safe and effective targeted therapies, a chelator, which strongly binds Cu-67 to the targeting agent, is required. Clarity Pharmaceuticals has successfully developed a highly specific and highly stable chelator for copper isotopes and is now progressing a range of radiopharmaceuticals based on its proprietary MeCOSar chelator. The IAC has developed a proprietary process for production of high purity and high specific activity Cu-67 to meet demand for clinical research and treatment.

Tyligand Bioscience and Context Therapeutics Sign Strategic Development Agreement for Onapristone ER

On March 12, 2020 Tyligand Bioscience, Ltd., a leader in small molecule drug discovery and development, and Context Therapeutics LLC, a clinical stage biopharmaceutical company focused on hormone driven cancers, reported the signing of collaboration agreements for the development, manufacturing, registration and future commercialization of onapristone extended release (ER) (Press release, Tyligand Bioscience, MAR 12, 2020, View Source [SID1234644992]).

Onapristone ER is currently being evaluated in patients with progesterone receptor positive (PR+) ovarian and endometrial cancers in the ongoing Phase 2 ONWARD 220 clinical trial. Initiation of additional Phase 2 clinical trials in ER+, PR+, HER2- breast cancer and endometrial cancers are planned for mid-2020.

Under the terms of the agreements, Tyligand will be solely responsible for the design and optimization of a novel manufacturing process for onapristone ER to meet Context’s development and future commercialization needs, and standards for quality, safety and cost. Upon completion of specific performance-based milestones, Tyligand will be granted the exclusive right and will be solely responsible for the development and commercialization of onapristone ER in China, Hong Kong and Macau (the "Territory"), and Context will be eligible to receive royalties on net sales of onapristone ER in the Territory. Context will retain rest of world rights to commercialize onapristone ER.

"We are thrilled to partner with Tyligand as we accelerate onapristone ER’s Phase 2 evaluation and prepare for Phase 3," said Martin Lehr, CEO of Context. "Tyligand is renowned for its expertise in process development and has strong networks with manufacturing and clinical capabilities in China and the U.S. Partnering with Tyligand will enable Context to optimize and efficiently scale our manufacturing and clinical capacity to support the evaluation and future commercialization of onapristone ER, our experimental oral therapy, to address the unmet need in treating patients with PR+ cancers."

"Even with the major advances in cancer therapies in recent years, treatment options for patients with hormone driven cancers remain limited," said Tony Zhang, CEO of Tyligand."Onapristone ER has the potential to be the first-in-class therapeutic agent specifically targeting progesterone receptors and the best-in-class treatment option for breast, endometrial and ovarian cancers. We are proud to partner with Context to develop onapristone ER and make this innovative medicine ultimately more accessible for patients around the world."

BridgeBio Pharma’s QED Therapeutics Announces Dosing Of First Patients In Phase 3 And Phase 2 Clinical Trials Of Infigratinib In Tumors With FGFR Genetic Alterations

On March 12, 2020 BridgeBio Pharma, Inc. (Nasdaq: BBIO) affiliate company QED Therapeutics reported that patients have been dosed in separate Phase 3 and Phase 2 clinical trials of infigratinib in cancer indications (Press release, BridgeBio, MAR 12, 2020, View Source [SID1234556926]).

The Phase 3 PROOF 302 trial sponsored by QED is studying infigratinib for the adjuvant (post-surgery) treatment of invasive urothelial carcinoma. A second, investigator-initiated trial, led by Sameek Roychowdhury, M.D., Ph.D., of The Ohio State University (OSU) Comprehensive Cancer Center, is studying infigratinib for the treatment of advanced and metastatic solid tumors with confirmed FGFR gene fusions/translocations or other FGFR alterations.

In the PROOF 302 trial, investigators are enrolling subjects with invasive urothelial cancer harboring susceptible FGFR3 genetic alterations who are at high risk of recurrence following surgical resection. Subjects will be randomized (1:1) to receive once daily oral infigratinib or placebo. The primary outcome is disease-free survival, and secondary outcomes include metastasis-free survival, overall survival, and safety and tolerability measures.

"Many patients with invasive urothelial carcinoma will have their cancer recur within two years after surgery," said PROOF 302 trial lead Sumanta Pal, M.D., professor of medical oncology and therapeutics research at City of Hope Comprehensive Cancer Center. "Correspondingly, I believe there are many patients who could benefit from an oral, post-surgery treatment option that targets FGFR3 alterations, the genetic driver of many urothelial carcinomas."

The Phase 2 study at OSU and selected sites within the Oncology Research Information Exchange Network (ORIEN) will evaluate the efficacy of infigratinib in patients who have advanced or metastatic solid tumors that are positive for FGFR1-3 gene fusions/translocations or other FGFR alterations. The open-label study will assess overall response rate as the primary outcome. Secondary outcomes include progression-free survival, best overall response, disease control rate, overall survival and measures of safety and tolerability.

"Increasingly, oncologists are learning to classify their patients’ cancers based on genetic mutations, going beyond the origin of the tumor," noted Dr. Roychowdhury. "Given the activity we have seen with infigratinib in FGFR2-fusion-driven bile duct cancers and FGFR3-altered urothelial carcinoma, our hope is that infigratinib will demonstrate similar activity in additional cancers that appear to be driven by alterations in FGFR. There appear to be multiple FGFR alterations that can drive cancer growth—and we hope to see these patients benefit too."

For additional information on the PROOF 302 trial, including eligibility, patients should ask their physician, visit clinicaltrials.gov, or email [email protected].

For additional information on the Phase 2 trial in metastatic solid tumors with FGFR gene alterations, including eligibility, patients should ask their physician, visit clinicaltrials.gov, or email [email protected].

NFCR-Backed Technology Receives FDA’s Assent for Lymphoma Clinical Trials

On March 12, 2020 The National Foundation for Cancer Research (NFCR)reported that it has recently been approved by the U.S. Food and Drug Administration (FDA) for the initiation of human clinical trials. The regulatory body accepted the Investigational New Drug (IND) application for ST-001, a unique intravenous (IV) nano-delivery system of the off-patent synthetic chemical compound fenretinide, for the experimental treatment of patients with T-cell non-Hodgkin’s lymphoma.

Fenretinide is a small-molecule which past studies have shown to be both safe and have cancer mitigating qualities. However, heretofore it has not been approved as a cancer therapeutic, largely due to the challenges of delivering it in adequate doses to tumor cells.

The molecule is highly hydrophobic, meaning poorly soluble in water. Therefore, the clinical use of fenretinide as a cancer therapeutic by itself is limited—that is, unless delivered to cancer cells in a manner via which the molecule’s insolubility will no longer be problematic. Existing technology has not yet solved this problem.

However, funded in part by an NFCR grant, a unique nanoparticle-based IV delivery system has been developed which shows promise in being able to address the insolubility challenge and administer therapeutically effective high doses of fenretinide. Phase I clinical trials for its safety are expected to begin later this year at the Rush University Medical Center in Chicago.

NFCR’s translational research support helped advance the cancer treatment technology, developed by scientists including the U.S. National Cancer Institute’s Ralph Parchment, Ph.D., to this crucial IND acceptance stage. Additionally, optimism for the prospect of the upcoming trials’ successful outcome is justified by earlier research on fenretinide conducted and published by multiple scientists, including Dartmouth College’s Michael Sporn, M.D., a former NFCR project director, showing the drug to be safe in humans after long periods of use.

"The acceptance by the FDA of ST-001’s IND application underscores the importance of research—basic and translational—in the battle against not only lymphoma, but all forms of cancer," said NFCR President and CEO Sujuan Ba, Ph.D. "It’s only novel research that can result in game-changing treatments for patients."