Spine BioPharma, Inc.

NEW YORK--( BUSINESS WIRE )--Spine BioPharma, Inc., a development stage company committed to non-opiate, non-surgical therapies for Degenerative Disc Disease (DDD), today announced the completion of enrollment of its U.S. Phase 3 clinical trial of SB-01 For Injection (SB-01). The Phase 3 MODEL trial ( MO derate – Severe Degenerative D isc Disease E valuation of the L umbar Spine) enrolled 417 patients at 30 investigational sites across the U.S., in a two-year period. SB-01 is the first intradiscal pharmacologic treatment to enter Phase 3 studies for the treatment of chronic low back pain (CLBP) and its associated pain-related loss of function caused by DDD. “ This is an important milestone for the patient and physician community, and for the Company. After years of conservative treatment, DDD patients have no alternative but to ultimately undergo surgery at a high dollar cost, with long recovery periods and unpredictable outcomes,” said Marc Viscogliosi, CEO of Spine BioPharma. “ We are extremely pleased to have completed enrollment of the SB-01 MODEL trial ahead of schedule. This accomplishment brings SB-01 one step closer to addressing the unmet need of millions of patients who suffer from CLBP associated with DDD.” Fran Magee DVM, Chief Technology Officer, stated: “ We would like to thank the patients, clinical trial site staff and physicians, and our vendor partners for their participation in this landmark trial. We believe the insights from the data collected during this trial may help shed light on treatment challenges and potentially offer a clinically meaningful new therapeutic treatment option for DDD patients.” Approximately 266 million individuals around the world experience DDD, and 22.5 million Americans are diagnosed with DDD, each year 1 . There is currently no targeted treatment for DDD, and existing approaches are aimed at managing symptoms through physical therapy, chiropractic care, Non-steroidal Anti-inflammatory Drugs (NSAIDS) or prescription opioids. For patients with chronic moderate-severe DDD, treatment plans include epidural steroid injections, nerve blocks, radiofrequency ablation or surgical intervention. Clinical outcomes vary and often do not provide predictable benefits. CLBP is the second leading cause of chronic opioid use 2 , which carries addiction risk and other serious side effects. About the MODEL Clinical Trial SB-01 MODEL clinical trial is a U.S. multi-center, randomized, double-blind, placebo-controlled Phase 3 trial being conducted to establish the safety and effectiveness of SB-01 For Injection in adult patients with chronic low back pain and its associated impairment in pain-related function due to Lumbar DDD. About SB-01 For Injection SB-01 is a 7-amino acid synthetic peptide that binds to and antagonizes TGF-Beta activity. TGF-Beta is a pleiotropic cytokine expressed by almost every tissue and cell type, is stored in abundance in the extracellular matrix, and possesses suppressive and stimulatory signaling pathways. In many diseases, there are high concentrations of TGF-Beta that result in a spectrum of negative downstream effects including inflammation, fibrosis, neoinnervation, hyperexcitability of nerves and cell proliferation. SB-01 modulates TGF-Beta concentration, without eliminating it, mitigating the negative downstream effects. About Spine BioPharma Spine BioPharma is committed to developing non-opiate, non-surgical treatments that will reduce pain, restore function, and slow or stop pathological disease progression. Spine BioPharma’s lead candidate, SB-01 For Injection, is a first-in-class treatment of DDD, offering potential clinical benefits of pain relief, restoration of function, and prevention of disease progression. To learn more about Spine BioPharma, visit www.spinebiopharma.com 1 Ravindra, Vijay, M., et al. Degenerative Lumbar Spine Disease: Estimating Global Incidence and Worldwide Volume. Global Spine J ournal . v.8(8); 2018 Dec. 2 Hudson, Teresa J., et al. Epidemiology of Regular Prescribed Opioid Use: Results from a National, Population-Based Survey. Journal of Pain and Symptom Management. 2008 Sep; 36(3): 280–288.

NEW YORK, July 10, 2024 /PRNewswire/ -- Spine BioPharma, Inc., a company committed to developing non-opiate, non-surgical therapies for the treatment of pain related disabilities, today announced that it has signed an agreement with Korean Company Ensol BioSciences, Inc. to expand the indications (treatment scope) of its therapeutic drug treatment candidate, SB-01 For Injection. The agreement, valued at a total of $155 million, grants Spine BioPharma the exclusive rights to develop and commercialize SB-01 For Injection, for all additional indications beyond spine-related diseases, such as Osteoarthritis, fibrotic diseases, and Oncological indications. In 2018, Spine BioPharma acquired the right to develop and commercialize SB-01 For Injection globally excluding Korea, from South Korean pharmaceutical and chemical company, Yuhan Corporation (who had originally licensed it from Ensol BioSciences). Spine BioPharma is currently conducting its SB-01 Phase 3 MODEL Study ( Moderate – Severe Degenerative Disc Disease Evaluation of the Lumbar Spine), the first intradiscal pharmacologic treatment to enter Phase 3 studies for the treatment of pain-related disability, associated with Degenerative Disc Disease (DDD) and anticipates completing trial enrollment of the 400-patient study in September 2024. (Clinicaltrials.gov: NCT05516992). Marc Viscogliosi, CEO of Spine BioPharma, stated, "We are very pleased to have finalized this agreement with Ensol BioSciences, and excited about the future portfolio expansion opportunities it provides, beyond spine-related diseases. This agreement, coupled with the anticipated conclusion of the SB-01 Phase 3 MODEL Study enrollment, certainly broadens Spine BioPharma's strategic framework considerations to address the unmet needs of patients suffering from pain related disabilities, and beyond". About SB-01 For Injection SB-01 is a 7-amino acid synthetic peptide that binds to and antagonizes TGF-Beta. TGF-Beta is a pleiotropic cytokine expressed by almost every tissue and cell type, is stored in abundance in the extracellular matrix, and possesses suppressive and stimulatory signaling pathways. In many diseases, there are high concentrations of TGF-Beta that result in a spectrum of negative downstream effects including inflammation, fibrosis, hypertension, neoinnervation, hyperexcitability of nerves and cell proliferation. SB-01 modulates TGF-Beta concentration, without eliminating it, mitigating the negative downstream effects. Considering this mechanism of action, SB-01 has potential in the treatment of other diseases beyond degenerative disc disease including osteoarthritis, fibrotic diseases, and other significant unmet medical needs. About Spine BioPharma Spine BioPharma is committed to developing non-surgical/non-opioid treatments that will reduce pain, restore function, and slow or stop pathological disease progression. Spine BioPharma's lead candidate, SB-01 For Injection, is a first-in-class treatment of degenerative disc disease, offering potential clinical benefits of pain relief, restoration of function, and prevention of disease progression. To learn more about Spine BioPharma, visit . Contact: Jason Gallagher Chief Commercial Officer & Chief Operating Officer [email protected] Office phone: (212) 583-9700 SOURCE Spine Biopharma, Inc

A biotech looking to create a non-opioid back pain med has reeled in more financing. Spine BioPharma put together a $13 million convertible note from insiders that will eventually close into a Series C, CEO Marc Viscogliosi told Endpoints News . That represents the same size as the biotech’s Series B from last spring. Investors include the CEO’s firm Viscogliosi Bros, Pacira Biosciences and Cercano Management, the investment firm of the late-Paul Allen, co-founder of Microsoft. The drug developer expects to complete a Phase III trial of its one-time injected non-opioid candidate later this year or early next year, with data slated for a mid-to-late 2024 readout, the CEO said. Spine expects to enroll 400 patients with lumbar degenerative disc disease in the placebo-controlled US trial of SB-01, according to the federal trials database. Viscogliosi said back pain is the number two reason for opioid prescriptions in the US, as the country deals with an epidemic of overdose deaths and the biopharma industry struggles to bring non-opioid options to fruition. The goal is to inhibit TGFβ, and if the drug is successful at shrinking the concentrations of that cytokine in the discs, then the thinking is inflammation will be tampered and pain modulated, Viscogliosi explained. In earlier-stage trials conducted by the original developers in Korea, EnsolBio and Yuhan Corporation, Viscogliosi said a majority of patients had a 15-point improvement at six months on a 50-point pain-related disability score known as the Oswestry Disability Index. The index is also the primary outcome being measured in the ongoing Phase III, he said. San Diego biotech aTyr Pharma looks to raise $50 million via a public offering of more than 22 million shares. The proceeds from the offering, expected to close on Feb. 13, will go toward the drug developer’s lead candidate, efzofitimod, which is in a Phase III trial in pulmonary sarcoidosis in the US and Japan. Partner Kyorin Pharmaceutical recently began the Japan portion of the global late-stage study, which means aTyr picked up $10 million . The funds will also help bankroll a planned Phase II study of the NRP2 agonist in patients with systemic sclerosis-associated interstitial lung disease, for which the drug has fast track designation at the FDA. That study is expected to begin this year, the biotech said. The stock price sank more than 7% in early morning trading to about $2.20 per share $LIFE . Spruce Biosciences will get $53.6 million via a private placement to finance late-stage development of tildacerfont for endocrine disorders, the biotech said Thursday morning. The proceeds will bring its runway into the first half of 2025, which means enough for two Phase IIb data readouts, CEO Javier Szwarcberg said in a statement. That includes taking the CRF1 receptor antagonist through CAHmelia-203 this year, with topline data in the second half of this year, and finishing up the second trial CAHmelia-204 , with high-level results in the second half of next year. Taking part in the securities purchase agreement are 5am Ventures, Abingworth, Armistice Capital, HealthCap, Novo Holdings, RiverVest Venture Partners and Rock Springs Capital. Shares $SPRB were up more than 5% to about $3.34 apiece after the opening bell but are well below the $32 peak shortly after Spruce’s 2020 IPO .