9 Meters Biopharma, Inc.

ROCKVILLE, Md., Aug. 21, 2023 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, announced today that Bethany L. Sensenig has joined the Supernus Board of Directors effective immediately. Ms. Sensenig has over twenty years of business and strategic financial leadership experience in the pharmaceutical and biotechnology sectors. The appointment will increase the size of the Supernus board to seven members. “Bethany brings a wealth of industry knowledge and expertise to the Company’s board,” said Jack Khattar, President and CEO of Supernus Pharmaceuticals. “As we continue to grow our commercial business, advance our pipeline and build our organization through corporate development, her strategic insights and operational and financial experience will be important for Supernus.” “I am pleased to join the board of Supernus and look forward to working with the other board members and the Supernus management team as the Company advances its mission of developing and commercializing products for the treatment of CNS diseases,” said Ms. Sensenig. Ms. Sensenig was most recently Chief Financial Officer and Interim Chief Executive Officer of 9 Meters Biopharma, a clinical-stage biotechnology company. Prior to that, Ms. Sensenig was Chief Financial Officer and Head of U.S. Operations of Minovia Therapeutics, Ltd., a clinical-stage biotechnology company, where she played a critical leadership role in building the company's business and financing strategy. She spent 13 years at Biogen Inc., a multinational biotechnology company, where she held several positions of increasing responsibility, the latest of which was Vice President of Finance and Commercial Operations. Ms. Sensenig has played key roles in numerous transactions and acquisition-related deals totaling over $2 billion across Biogen and Minovia and had direct P&L accountability at Biogen for upwards of $1 billion in annual revenue across 30 countries spanning the U.S., Asia-Pacific, Latin America and Europe. Earlier in her career, Ms. Sensenig held financial management and analyst roles at Merck & Co. Inc. and Nexus Technologies, Inc. Ms. Sensenig holds a Bachelor of Science in Accounting and Business Management from Montreat College, a Master of Business Administration from Western Carolina University and is a Certified Management Accountant. About Supernus Pharmaceuticals, Inc. Supernus Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases. Our diverse neuroscience portfolio includes approved treatments for epilepsy, migraine, ADHD, hypomobility in Parkinson’s disease (PD), cervical dystonia, chronic sialorrhea, dyskinesia in PD patients receiving levodopa-based therapy, and drug-induced extrapyramidal reactions in adult patients. We are developing a broad range of novel CNS product candidates including new potential treatments for hypomobility in PD, epilepsy, depression, and other CNS disorders. For more information, please visit www.supernus.com. Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements do not convey historical information but relate to predicted or potential future events that are based upon management's current expectations. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. In addition to the factors mentioned in this press release, such risks and uncertainties include, but are not limited to, the Company’s ability to sustain and increase its profitability; the Company’s ability to raise sufficient capital to fully implement its corporate strategy; the implementation of the Company’s corporate strategy; the Company’s future financial performance and projected expenditures; the Company’s ability to increase the number of prescriptions written for each of its products and the products of its subsidiaries; the Company’s ability to increase its net revenue; the Company’s ability to commercialize its products and the products of its subsidiaries; the Company’s ability to enter into future collaborations with pharmaceutical companies and academic institutions or to obtain funding from government agencies; the Company’s product research and development activities, including the timing and progress of the Company’s clinical trials, and projected expenditures; the Company’s ability to receive, and the timing of any receipt of, regulatory approvals to develop and commercialize the Company’s product candidates; the Company’s ability to protect its intellectual property and the intellectual property of its subsidiaries and operate its business without infringing upon the intellectual property rights of others; the Company’s expectations regarding federal, state and foreign regulatory requirements; the therapeutic benefits, effectiveness and safety of the Company’s product candidates; the accuracy of the Company’s estimates of the size and characteristics of the markets that may be addressed by its product candidates; the Company’s ability to increase its manufacturing capabilities for its products and product candidates; the Company’s projected markets and growth in markets; the Company’s product formulations and patient needs and potential funding sources; the Company’s staffing needs; the Company’s ability to increase the number of prescriptions written for each of its products and the products of its subsidiaries; the Company’s ability to increase its net revenue from its products and the products of its subsidiaries; and other risk factors set forth from time to time in the Company’s filings with the Securities and Exchange Commission made pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended. The Company undertakes no obligation to update the information in this press release to reflect events or circumstances after the date hereof or to reflect the occurrence of anticipated or unanticipated events. CONTACTS: Jack A. Khattar, President and CEOTimothy C. Dec, Senior Vice President and CFOSupernus Pharmaceuticals, Inc.Tel: (301) 838-2591 or INVESTOR CONTACT: Peter VozzoICR WestwickeOffice: (443) 213-0505Email: peter.vozzo@westwicke.com

9 Meters was planning on running a second phase 2 trial for its lead asset before deciding to file for bankruptcy. You can’t get far with $150,000 in drug development, a painful realization that 9 Meters Biopharma knows all too well, as the North Carolina-based biotech filed for bankruptcy. The company disclosed its decision late Tuesday, a day after telling a federal bankruptcy court that it couldn’t continue. The company reported roughly $152,000 in cash on hand in addition to $4 million in intangibles and intellectual property, according to a court filing. The biotech previously reported having $6.9 million in cash and cash equivalents as of the end of March.  The irony is that the company currently has a mid-stage GLP-1 inhibitor, a potentially hot-ticket item given the class's budding use in weight loss management. But 9 Meters was aiming vurolenatide at short bowel syndrome. The drug had also begun to stall in the clinic, after the company announced in late May that, following a conversation with U.S. regulators, it was likely best for vurolenatide to be tested in another phase 2 trial rather than advance to phase 3. The company also announced at the time that CEO John Temperato was resigning.  But there was no explicit indication in 9 Meters’ most recent earnings report that the biotech was on the precipice of dissolving. In fact, the company said at the time that it had positive interactions with the FDA regarding the potential launch of NM-136—an anti-GIP antibody to treat obesity—into the clinic and was planning on doing so.  9 Meters also raised a $5 million direct offering in mid-March that was slated to fund both further development of vurolenatide and NM-136. But the company was also contending with a lender that held millions in a convertible note. 9 Meters and the holder of the note reached an agreement in late April whereby the biotech didn’t have to pay up in full, at least at the time—an agreement that was subsequently amended twice. Those extensions have been terminated as a result of the bankruptcy filing.  Though 9 Meters seemed to be making progress, albeit at a trickle, the biotech was still stalked by prior failures, most recently in 2022 when larazotide flopped in a phase 3 trial for patients with celiac disease. The company has since pivoted, aiming that drug at a couple of COVID-related conditions, including multi-system inflammatory syndrome in children and long COVID.

Lead bispecific antibody, HSB-3215 designed to target novel conformational epitopes on high value validated targets, HER2 and HER3 Focus on optimizing ADCs to generate a more potent Bystander Effect and proprietary novel bovine-derived biologic platform, PicoKnobTM, targeting undruggable epitopes on PD-1 and TROP2 Experienced biopharmaceutical executive joins as Chief Operating Officer to spearhead execution of ADC and biologic strategy BRIDGEWATER, N.J., July 10, 2023 (GLOBE NEWSWIRE) -- Hillstream BioPharma (Nasdaq: HILS) a biotechnology company developing innovative therapeutic candidates targeting drug resistant and devastating cancers that can make a difference in patients’ lives, today announced a strategic reprioritization of its pipeline and provided a corporate update. The strategic assessment took into account, the pipeline’s near-term value creation opportunity and other factors. Hillstream will focus its pipeline on advancing novel oncology assets with the greatest potential and strong competitive profiles to address unmet needs across multiple solid tumors, such as bispecific antibodies and ADCs targeting novel conformational epitopes on high value validated targets, HER2 and HER3, with a more potent Bystander Effect. Bispecific antibodies (BsAbs) refer to a diverse group of molecules that recognize distinct epitopes on two different antigens, such as HER2 and HER3. These validated targets have been extensively studied and belong to the ERBB receptor tyrosine kinase family and are exploited by cancer cells to promote tumorigenesis and metastasis. HER2, an extensively studied and validated target, has multiple approved therapeutics for solid tumors. Meanwhile, emerging evidence suggests that HER3 plays a central role through interacting with neighboring receptors. While HER3 has little to no tyrosine kinase activity on its own, its activation to promote tumors depends on heterodimerization or locking into place with HER2 and EGFR, which is believed to unlock its cancer-causing potential. Hillstream’s lead asset, HSB-3215 is designed as a bispecific humanized immunoglobulin containing two arms targeting the extracellular domains of HER2 and HER3. HSB-3215 binds to both overlapping and different epitopes on HER2 when compared to trastuzumab, the first approved antibody against HER2, while adhering to novel epitopes on HER3, thus creating novel conformational epitopes. The Company intends to develop this novel BsAb and IND application with the US FDA late next year. By exploiting the “Bystander Effect”, a key aspect of ADCs which has been recently highlighted by the improved clinical efficacy of Daiichi Sankyo/AstraZeneca’s ENHERTU® (trastuzumab deruxtecan), the Company plans to optimize its BsAb pipeline with BiSpecific ADCs, i.e. BiSpecific antibodies conjugated with novel toxin payloads which are optimized to generate a more powerful Bystander Effect. ADCs are comprised of a targeting antibody chemically conjugated via a proprietary linker to a powerful, cancer-killing compound/toxin (payload). With a BsAb backbone utilizing HSB-3215, the Company intends to develop novel ADCs, targeting HER2/HER3 and better direct a payload to cancer cells overexpressing these receptors, while healthy cells don’t take up the unwanted compound. Hillstream also intends to further enhance its previously announced collaborations with Applied Biomedical Science Institute (ABSI) and Minotaur to develop novel bovine-derived biologics in multiple formats against highly validated targets, including PD-1, HER2 and TROP-2, referred to as PicoKnobsTM. An update regarding these collaborations will be announced during an R&D Day in the third quarter. “Our recently announced collaborations with ABSI are transforming Hillstream into a focused and targeted cancer biologics company,” said Randy Milby, Chairman and CEO of Hillstream. “With the HER2 and HER3 platform, we are building a diverse foundation of targeted biologics which can be utilized for our current portfolio as well for future in-licensed assets. We are confident that our focused approach and experienced management team best positions us for success.” The Company also announced the appointment of Sireesh Appajosyula, Pharm.D.as as Chief Operating Officer (COO). Sireesh brings over 20 years of experience in creating and advising biotechnology companies such as 9 Meters Biopharma Inc. through targeted transactions thus creating a pipeline as well as accessing the public capital markets. He was responsible for corporate development including portfolio strategy, in-licensing transactions and alliances for 9 Meters’s core assets as well as monetization of non-core assets. Previously, he spent eight years at Salix Pharmaceuticals, Inc. in various roles including medical & clinical affairs, product commercialization and business development culminating in Salix’s acquisition for $16 billion by Bausch Health. Prior to Salix, Sireesh held increasing roles and responsibilities at Amgen, Chiesi (Critical Therapeutics) and Sanofi S.A. (Aventis). Sireesh holds a Doctor of Pharmacy degree from the Ernest Mario College of Pharmacy at Rutgers University in New Jersey. “I am thrilled to join Hillstream and look forward to working alongside the team as we further our development programs. I believe the Company’s precision oncology strategy with the current HER2/HER3 antibody programs and pipeline have the potential to bring much needed treatments to cancer patients,” said Dr. Appajosyula. About Hillstream BioPharma, Inc. Hillstream BioPharma, Inc. is a biotechnology company developing a focused portfolio of therapeutic candidates targeting drug resistant and devastating cancers. The Company’s emerging immuno-oncology pipeline is led by HSB-3215, a novel anti-HER2 monoclonal antibody targeting unique epitopes with a novel mechanism of action. The erbB/HER family of cell surface proteins include well-known and validated drug targets including HER2 and HER3 found in multiple solid tumors, including breast, lung, GYN, endocrinological and CNS. For more information, please visit: . Forward Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Hillstream’s expectations, strategy, plans or intentions. These forward-looking statements are based on Hillstream’s current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; risks related to business interruptions which could seriously harm our financial condition and increase our costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain Food and Drug Administration (“FDA”) clearances or approvals and noncompliance with FDA regulations. Investors should read the risk factors set forth in our Form 10-K for the year ended December 31, 2022, and our periodic reports filed with the Securities and Exchange Commission. However, these risks are not exhaustive and new risks and uncertainties emerge from time to time and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this press release. Forward-looking statements included herein are made as of the date hereof, and Hillstream does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances, except as may be required by law. Investor Relations Contact Email: investorrelations@hillstreambio.com