8-K – Current report

On July 14, 2023 Exicure, Inc. (Nasdaq: XCUR), reported that it has historically been an early-stage biotechnology company focused on developing nucleic acid therapies targeting ribonucleic acid against validated targets (Press release, Exicure, JUL 14, 2023, View Source [SID1234633241]). In September 2022, the Company announced a significant reduction in force, suspension of preclinical activities and halting of all research and development, and that the Company was exploring strategic alternatives to maximize stockholder value.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Corporate Update

Recent highlights include:

•On February 24, 2023, the Company received gross proceeds of $5.44 million from the September 2022 PIPE (net proceeds of $4.6 million after transaction expenses). As a result of the closing of the September 2022 PIPE, CBI USA is the beneficial owner of approximately 50.4% of the Company’s outstanding shares. Pursuant to the board designation rights of CBI USA, CBI USA designated three members to the Company’s board of directors.

•In May, the Company entered into two separate subscription agreements ("Subscription Agreements") with Cyworld Z Co., Ltd., ("Cyworld Z"). Pursuant to the Subscription Agreements, the Company purchased non-guaranteed private placement convertible bonds ("Bonds") of Cyworld Z for a subscription amount of $1 million each. The Bonds mature in May 2026 and the yield to maturity is 4.5% per annum.

First Quarter 2023 Financial Results

Cash Position: Cash, cash equivalents and restricted cash were $11.2 million as of March 31, 2023, as compared to $9.8 million as of December 31, 2022. The Company expects that its cash and cash equivalents will fund its current operations into the fourth quarter of 2023.

Research and Development (R&D) Expense: Research and development expenses were $2.0 million for the quarter ended March 31, 2023, as compared to $7.1 million for the quarter ended March 31, 2022. The decrease in R&D expense for the three months ended March 31, 2023 of $5.2 million reflects the suspension of clinical, preclinical, and discovery program activities and a reduction in employee headcount and fewer discovery, preclinical, and clinical program activities resulting from the restructuring activities that the Company announced in September 2022 and in December 2021.

General and Administrative (G&A) Expense: General and administrative expenses were $2.6 million for the quarter ended March 31, 2023, as compared to $3.2 million for the quarter ended March 31, 2022. The decrease in G&A expense of $0.6 million for the three months ended March 31, 2023 was mostly due to lower retention award and bonus compensation, based on current estimates, as well as lower legal fees and insurance. These decreases were partially offset by less operating costs allocated out to R&D based on changes in headcount.

Net Loss: The Company had a net loss of $4.4 million for the quarter ended March 31, 2023, as compared to a net loss of $8.3 million for the quarter ended March 31, 2022. The decrease in net loss was primarily driven by lower R&D expenses during the period, partially offset by lower revenue.

Going Concern: Management believes that the Company’s existing cash and cash equivalents will fund its operating expenses into the fourth quarter of 2023. However, this estimate is based on assumptions

about how the Company can limit spending that may prove to be wrong. It is very difficult to project the Company’s current cash burn rate given the transitional status of the Company and this estimate may prove inaccurate. Depending on the direction of the Company’s review of strategic alternatives, the Company may use available resources sooner than management currently expects. The Company has already engaged in significant cost reductions, so our ability to further cut costs and extend the Company’s operating runway is limited. As a result, substantial additional financing will be needed by the Company within the next few months to pay expenses, fund the ongoing exploration of strategic alternatives and pursue any alternatives that may be identified. The Company seeks to raise capital in the third quarter of 2023 to fund its operations through 2024. There can be no assurance that such additional financing will be available and, if available, can be obtained on acceptable terms.

Aravive to Participate in William Blair’s Innovator Series: Transitioning Biotech Breakthroughs to Commercial Success Being Held July 18, 2023

On July 14, 2023 Aravive, Inc. (Nasdaq: ARAV, "the Company"), a late clinical-stage oncology company developing targeted therapeutics to treat metastatic disease reported that Gail McIntyre, Ph.D., DABT, Chief Executive Officer will be participating in a fireside chat at the William Blair Innovator Series: Transitioning Biotech Breakthroughs to Commercial Success being held virtually on July 18, 2023 (Press release, Aravive, JUL 14, 2023, View Source [SID1234633239]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

William Blair’s Innovator Series: Transitioning Biotech Breakthroughs to Commercial Success
Format: Fireside Chat with Aravive (ARAV)
Date/Time: Tuesday, July 18, 2023 at 12:00-12:45 PM ET
Host: Andy Hsieh, Ph.D., Biotech Research Analyst, William Blair
Presenter: Gail McIntyre, Ph.D., DABT, CEO, Aravive
Webcast: Conference attendees can check the schedule for more details or reach out to their William Blair salesperson.

A replay of the session will be available for 7 days following the event through the Aravive Events & Presentations section of the website View Source

InnoCare and ArriVent Announce Clinical Development Collaboration

On July 13, 2023 InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases and ArriVent Biopharma, a clinical stage company dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, reported a clinical development collaboration to evaluate the combination of InnoCare’s novel SHP2 (Src Homology 2 domain containing protein tyrosine phosphatase) allosteric inhibitor, ICP-189, with ArriVent’s furmonertinib, a highly brain-penetrant, broadly active mutation-selective EGFR (epidermal growth factor receptor) inhibitor (Press release, ArriVent Biopharma, JUL 14, 2023, https://arrivent.com/press-release/innocare-and-arrivent-announce-clinical-development-collaboration/?utm_source=rss&utm_medium=rss&utm_campaign=innocare-and-arrivent-announce-clinical-development-collaboration [SID1234633215]). Under the agreement, InnoCare and ArriVent will jointly conduct a clinical study to evaluate the anti-tumor activity and safety of ICP-189 combined with furmonertinib in patients with advanced non-small cell lung cancer (NSCLC).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Furmonertinib is being advanced by ArriVent in global studies in patients with advanced or metastatic NSCLC with EGFR or HER2 mutations, including exon 20 insertion mutations. It is approved in China as a first-line treatment for adults with locally advanced or metastatic NSCLC with EGFR exon 19 deletion (19DEL) or exon 21 (L858R) substitution mutations, where it is being further developed for additional indications with Allist Pharmaceuticals who discovered furmonertinib.

ICP-189 is a potent and selective oral allosteric inhibitor of SHP2, developed by InnoCare for the treatment of solid tumors as a single agent and/or in combination with other antitumor agents. In a dose escalation study, ICP-189 demonstrated favorable PK, long half-life and safety and tolerability.

Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare, said: "NSCLC is the major subtype of lung cancer with huge unmet medical needs. We are glad to work with ArriVent to push forward the combination study and expect this innovative therapy to benefit global patients early."

"We are excited to announce this clinical development collaboration with InnoCare," said Bing Yao, Ph.D., Chairman, Co-founder and Chief Executive Officer of ArriVent. "Combining furmonertinib with ICP-189 represents the growing opportunity for our furmonertinib clinical development program, in addition to ongoing studies in the monotherapy setting. If successful in clinical trials and approved, the combination of furmonertinib with SHP2 inhibitors could be another potential treatment option to help improve the lives of people living with advanced or metastatic lung cancer."

NSCLC is the predominant subtype of lung cancer, accounting for approximately 85% of all cases.

Crossbow Therapeutics Launches with $80 Million in Series A Financing to Advance a Novel Class of Antibody Therapies That Mimic T-Cell Receptors to Treat Cancer

On July 13, 2023 Crossbow Therapeutics, Inc., a biotechnology company developing a novel class of potent and precise antibody therapies to treat a broad range of cancers, reported an $80 million Series A funding round led by MPM BioImpact and Pfizer Ventures, with participation from Polaris Partners, BVF Partners, Eli Lilly and Company, Mirae Asset Venture Investment, and Mirae Asset Capital (Press release, Crossbow Therapeutics, JUL 13, 2023, View Source [SID1234638849]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Series A financing will allow Crossbow to advance the development of novel therapies that potently target peptide-loaded major histocompatibility complexes (pMHCs) on cancer cells, using antibodies that mimic T-cell receptors (TCR-mimetics). Crossbow’s development process starts with the identification, validation, and prioritization of the most promising cancer-specific targets. Using proprietary technology, the company then develops TCR-mimetic antibodies with both high affinity and specificity for cancer cells. Crossbow incorporates these TCR-mimetics into off-the-shelf, easy-to-assemble T-cell engagers and other immunotherapies. The resulting products, known as T-Bolt molecules (short for "tumor-bolts"), can be adapted to address a broad range of cancers. Crossbow can leverage this innovative approach to potently target the entire universe of cancer proteins.

"We aim to cure cancer," said Briggs Morrison, M.D., Chief Executive Officer of Crossbow Therapeutics. "With unparalleled accuracy and potency, our revolutionary T-Bolt products strike cancer cells like a crossbow shoots bolts at its target. The influx of additional capital enables us to scale our efforts to build an arsenal of TCR-mimetic-based immunotherapies designed to overcome the limitations of current treatments."

"Our continued investment in Crossbow Therapeutics reflects our confidence in the team’s differentiated approach to vastly expand the range of targets for immunotherapies," commented Todd Foley, Managing Director of MPM BioImpact and Co-Founder and Chair of the Crossbow Board of Directors.

"We are impressed by the strong foundation Crossbow has built and world-class team it put together. We are excited to support the company in its efforts to transform cancer care with its innovative and far-reaching T-Bolt therapies," said Irena Melnikova, Partner at Pfizer Ventures and Member of the Crossbow Board of Directors.

Crossbow was founded, seeded, and incubated at MPM BioImpact by Patrick Baeuerle, Ph.D.; Todd Foley; and Geraldine Paulus, Ph.D., who has since joined the company as its Vice President of Corporate Development and Operations. The founders assembled an international, collaborative, and passionate team with unmatched experience in inventing and developing next-generation cancer therapies. As Chief Executive Officer, Dr. Briggs Morrison brings over 30 years of pharmaceutical and biotechnology industry experience to his position, having previously served in executive roles at Syndax Pharmaceuticals, AstraZeneca, Pfizer, and Merck. Dmitri Wiederschain, Ph.D., recently joined the company as Chief Scientific Officer after previous leadership roles at Jounce Therapeutics, Sanofi, and Novartis.

Elevation Oncology Appoints Joseph Ferra as Chief Executive Officer and Promotes Tammy Furlong to Chief Financial Officer

On July 13, 2023 Elevation Oncology, Inc. (Nasdaq: ELEV), an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs, reported the appointment of Joseph Ferra, M.B.A., as its Chief Executive Officer (Press release, Elevation Oncology, JUL 13, 2023, View Source;utm_medium=rss&utm_campaign=elevation-oncology-appoints-joseph-ferra-as-chief-executive-officer-and-promotes-tammy-furlong-to-chief-financial-officer [SID1234633240]). Mr. Ferra was previously Interim Chief Executive Officer and Chief Financial Officer. Mr. Ferra will also join the Elevation Oncology Board of Directors. In addition, the Company announced the appointment of Tammy Furlong, M.B.A., C.P.A., as Chief Financial Officer, promoted from her previous role as Vice President of Finance and Accounting.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"I am honored to formally take on the role of CEO at Elevation Oncology and thrilled to lead the Company during this pivotal stage as we initiate our Phase 1 clinical trial evaluating EO-3021 in the U.S. this year," said Mr. Ferra. "The preclinical and clinical data presented in recent months strengthen our conviction that EO-3021 is a potential best-in-class antibody-drug conjugate for treating patients whose solid tumors express Claudin 18.2. I look forward to continuing our work and building on our successes as we continue to drive growth and innovation in the field of selective oncology therapies."

"I have had the pleasure to witness firsthand the passion and dedication we bring to developing new therapies for patients in need, and am excited for the opportunity to continue working closely with our talented team in my new role," added Ms. Furlong.

"We are delighted to appoint Joe and Tammy as CEO and CFO, respectively, given the wealth of knowledge, experience and leadership skills they bring," said Steve Elms, Chairman of the Board of Directors of Elevation Oncology. "This is an exceptionally exciting time for Elevation Oncology as we drive EO-3021 toward the clinic to further demonstrate its potential to target Claudin 18.2 and improve clinical outcomes for patients. Joe and Tammy bring proven records of achievement as biotechnology executives and the Board is confident that they, along with the entire leadership team, have the expertise, passion and commitment to drive the Company to success."

Mr. Ferra has over 20 years of experience in financial, strategic, and leadership roles in the biotechnology and pharmaceutical industry. He previously served as Chief Financial Officer of Syros Pharmaceuticals, leading and coordinating financial and capital strategies and operational aspects for the company. Prior, he spent over a decade working in biotechnology and pharmaceutical investment banking, and he served as Managing Director and Co-Head of Healthcare Investment Banking at JMP Securities and was a member of the investment banking groups at JP Morgan and UBS. In 2021, he became Chief Financial Officer of Elevation and in January of 2023, he was appointed Interim Chief Executive Officer. Mr. Ferra obtained a B.S. in Chemistry with Distinction from Purdue University and later completed his M.B.A. at The Stephen M. Ross School of Business at the University of Michigan.

Ms. Furlong has extensive leadership experience in accounting, financial reporting, information systems, financial transformation, global strategy and management areas encompassing more than 20 years with Fortune 500 publicly traded companies. She has served as the Vice President of Finance and Accounting at Elevation Oncology, leading its financial and operational teams since 2021. Prior to Elevation Oncology, she was a finance consultant where she focused on capital raising, strategic transactions and finance operations for multiple biotechnology and pharmaceutical companies. Ms. Furlong received a B.S. in Accounting from Adelphi University, an M.B.A. from Bentley University, and a Graduate Certificate in Project Management from the Boston University Metropolitan College. She is also a Certified Public Accountant licensed in Massachusetts and a Project Management Professional with the Project Management Institute.