TGR5

Biotech startup Enveda has raised a $130 million Series C, the Colorado company said Thursday morning. Founded and led by early Recursion employee Viswa Colluru, the startup will use the funds to back its pipeline of 10 drug development candidates, including one that entered human studies last month. The new financing will get the 250-employee startup to clinical proof-of-concept for three to five of those candidates, Colluru said in a phone interview on Thursday. That includes a once-daily, oral obesity drug that will enter human trials around the middle of next year, he said. The five-year-old company maps the chemistry of plants and employs machine learning and other methods to create therapeutics based on those insights. Enveda believes nature can serve as the foundation for a new generation of medicines, just as morphine, aspirin, metformin, warfarin and others have all come from nature. “It’s funny, when you think about the core of Enveda being natural products, every pharma company would scoff at that and be like, ‘Look, we tried that. It’s not an interesting place,’” Shaquille Vayda, principal at Lux Capital, told Endpoints News last year. Enveda entered the clinic last month with its first drug candidate, ENV-294, an experimental oral treatment for atopic dermatitis, among other inflammatory indications. The drug has attracted pharma interest, Colluru said, noting the company could explore partnerships on some of its programs. It had expected to enter human trials in 2023, Colluru told Endpoints at the time of a December 2022 Series B announcement. Beyond anti-inflammatories, Enveda is also working in obesity (with a hormone mimetic), multiple forms of fibrosis, chronic pain and neurological indications. It’s working on MRGPRX4 antagonists, NLRP3 and TL1A pathway inhibitors, and TGR5 agonists, among others. With the new funds, Enveda has now raised a total of $360 million from Lux Capital, Dimension Capital , Microsoft, Kinnevik, Baillie Gifford and multiple other investors. And it has grown quickly: Colluru previously told Endpoints he initially invested $50,000 of his own money into the company alongside $220,000 from friends and family. He said the company now has flexibility with regard to its next financing step. “The potential here is massive, but there’s enough wood to chop just on the therapeutics side, where I think there’s a $50 billion company to be built just on therapeutics alone in the next decade,” Zavain Dar, a co-founder of VC firm Dimension, previously told Endpoints. The company also has a footprint in India, where Colluru grew up.

210 Patients With Multi-Racial Atopic Dermatitis...Phase 2 Clinical Trial Begins CAMBRIDGE, Mass. & SEOUL, South Korea--(BUSINESS WIRE)-- Shaperon, Inc. (Kosdaq: 378800), a biotechnology company developing innovative immune drugs, announced the enrollment of the first patient in the Phase 2 clinical trial for Nugel, its therapy for Atopic Dermatitis. This milestone marks the start of a crucial phase in Shaperon’s effort to advance treatment for patients globally. With FDA approval secured for the Global Phase 2 Clinical Trials (IND) of Nugel in September 2023, Shaperon is dedicated to evaluating its efficacy in improving the Eczema Area Severity Index (EASI) across a diverse cohort of 210 patients with mild to moderate atopic dermatitis. Employing a rigorous double-blind, placebo-controlled methodology, the trial is anticipated to conclude by the first half of 2026. Market research forecasts indicate a robust growth of over 8.7%, projecting the global atopic dermatitis market to reach $19.1 billion by 2030. Presently, patients rely on steroids and FDA-approved medications, yet there remains a pressing need for novel drugs due to their adverse effects and limited efficacy. Of particular note, more than 70% of patients exhibit positive responses to the biomarker discovered during Shaperon's phase 2 clinical trials in Korea, categorized as "A type A atopic patients." This treatment, distinguished by its superior safety and efficacy compared to existing JAK inhibitors or PDE4 inhibitors in the market, has garnered attention at U.S. and European forums. Shaperon has already initiated patent applications for this biomarker, enabling tailored treatments for patients showing exceptional responses to Nugel. Nugel represents a paradigm shift in atopic dermatitis therapy as the world's first inflammation control drug targeting 'GPCR19' action. Its unique mechanism of action, exclusive to immune-related cells, offers minimal side effects while effectively addressing inflammatory pathways. Beyond atopic dermatitis, Nugel holds promise for treating a spectrum of skin conditions, further underscoring its potential impact on global healthcare. Dr. Seung-Yong Seong, CEO of Shaperon, reaffirms Shaperon's commitment to advancing Nugel's global presence and facilitating technology transfer through the Phase 2 clinical trials. Leveraging innovative approaches such as a smartwatch-based AI medication management system demonstrates Shaperon's dedication to optimizing patient outcomes and data reliability. The establishment of Hudson Therapeutics, Shaperon's U.S.-based subsidiary, reinforces its strategic vision for global expansion and technology exports. ABOUT SHAPERON Shaperon is a clinical stage biotech company developing novel inflammasome inhibitors. Its unique mechanism of action of GPCR19-P2X7 modulation suppresses a broad spectrum of inflammatory cytokines including IL-1β, IL-18, IL-6, and TNF-α by controlling both priming and activation phase of inflammasome, whereas conventional approaches are designed to suppress only the activation phase. With this unique and novel modality which is best suited to address complex immune-mediated inflammatory disorders, Shaperon is currently developing multiple clinical programs in atopic dermatitis, cytokine release syndrome, Alzheimer’s disease, Obesity and MASH. ABOUT Hudson Therapeutics Hudson Therapeutics, a US subsidiary of Shaperon, was founded in 2023 to lead global clinical trials and business development of assets from Shaperon. Hudson’s pipeline includes immunology clinical assets in Atopic Dermatitis, Covid-19, Alzheimer’s Disease and preclinical programs focused in Obesity and other indications, combined with their nanobody platform. View source version on businesswire.com: Contacts Ellie Jung (ellie@hudsontherapeutics.com) Source: Shaperon View this news release online at:

Continued successful launch of IBSRELA, with Q1 net product sales of $11.4 million XPHOZAH New Drug Application resubmitted on April 17, 2023 Company ends Q1 with over $130 million in cash and investments Conference call scheduled for 4:30 PM Eastern Time WALTHAM, Mass., May 03, 2023 (GLOBE NEWSWIRE) -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today reported financial results for the first quarter ended March 31, 2023 and provided a business update. “During the first quarter of 2023, we demonstrated progress towards achieving our goals for 2023. At one-year post-launch, IBSRELA is being recognized as an important medicine for IBS-C and is delivering meaningful benefits to patients. We are consistently gaining market share with our innovative commercial strategy. At the same time, during the first quarter, we continued to advance XPHOZAH to approval and launch and pursued business development opportunities that would bring our novel mechanism technologies to patients and strengthen our cash position,” said Mike Raab, president and chief executive officer of Ardelyx. “As we look towards the remainder of the year, we will continue to focus on achieving our near-term milestones, including driving IBSRELA adoption, preparing to launch XPHOZAH in the second half of this year pending FDA approval, and building on our strategy for the next phase of the company’s growth.” IBSRELA® (tenapanor) Update: Growth continues with $11.4 million in net product sales in Q1 2023In March 2023, Ardelyx completed one full year of IBSRELA sales following the U.S. launch in 2022 for the treatment of irritable bowel syndrome with constipation (IBS-C) in adults. IBSRELA continues to gain market share as a result of the company executing on its innovative launch strategy focused on high-writing physicians and the patients who experience persistent symptoms, despite treatment with a prescription therapy for IBS-C. The company continues to see increased new and refill prescriptions as well as persistent growth in new and repeat writing healthcare providers. XPHOZAH® (tenapanor) Update: New Drug Application (NDA) resubmitted On April 17, 2023, Ardelyx resubmitted the NDA for XPHOZAH for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis who have had an inadequate response or intolerance to a phosphate binder therapy to the U.S. Food and Drug Administration (FDA). An Acknowledgement of Receipt letter from the FDA, confirming the resubmission is complete, is expected in mid-May. The letter will include the classification of the resubmission and the review goal date. Launch preparation activities are underway to support a second half of 2023 launch, pending FDA approval. Other Corporate Developments In April, the company signed an agreement with METiS Therapeutics, Inc. to license Ardelyx’s portfolio of TGR5 agonist compounds. METiS Therapeutics is a Boston-area company integrating drug discovery and delivery with AI and machine learning. The agreement provides METiS with the exclusive, worldwide rights to develop and commercialize a portfolio of TGR5 agonist compounds that were discovered and developed by Ardelyx for all therapeutic areas. Under the terms of the agreement, Ardelyx received an upfront payment of $750,000 and is eligible to receive additional development and sales milestones of up to $243 million, as well as tiered royalty payments on net sales ranging from the low- to mid-single digits. TGR5, as a metabolic regulator, is involved in energy homeostasis, bile acid homeostasis, glucose metabolism and metabolic regulation.Ardelyx presented three posters covering additional positive clinical observations of XPHOZAH at the National Kidney Foundation (NKF) 2023 Spring Clinical Meetings, which took place in Austin, TX from April 11-15, 2023. First Quarter 2023 Financial Results Cash Position: As of March 31, 2023, the company had total cash, cash equivalents and short-term investments of $130.4 million, as compared to total cash, cash equivalents and short-term investments of $123.9 million as of December 31, 2022. During the quarter ended March 31, 2023, the company received gross proceeds of $51.9 million for the sale of 15.5 million shares of the company’s common stock under the company’s sales agreement with Jefferies LLC, dated August 13, 2021, deemed to be “at-the-market offerings.”Product Sales: Net product sales for IBSRELA were $11.4 million during the quarter ended March 31, 2023, compared to $0.5 million for the quarter ended March 31, 2022, when the first product sales for IBSRELA were recognized.R&D Expenses: Research and development expenses were $9.1 million for the quarter ended March 31, 2023, compared to $8.9 million for the quarter ended March 31, 2022.SG&A Expenses: Selling, general and administrative expenses were $26.8 million for the quarter ended March 31, 2023, an increase of $7.5 million compared to $19.3 million for the quarter ended March 31, 2022. The increase in selling, general and administrative expenses was primarily due to increased costs associated with the ongoing commercial launch of IBSRELA.Net Loss: Net loss for the quarter ended March 31, 2023 was $26.8 million, or $(0.13) per share, compared to net loss of $28.1 million, or $(0.21) per share, for the quarter ended March 31, 2022. The net loss for the quarter ended March 31, 2023 included share-based compensation expense of $2.9 million, non-cash interest expense related to the sale of future royalties of $1.0 million and a non-cash impairment of a lease right of use asset of $0.4 million. Conference Call DetailsThe company will host a conference call today, May 3, 2023, at 4:30 PM ET to discuss today's announcement. To participate in the conference call, please dial (844) 481-2838 (domestic) or (412) 317-1858 (international) and ask to be joined into the Ardelyx call. A webcast of the call can also be accessed by visiting the Investor page of the company's website, www.ardelyx.com, and will be available on the website for 30 days following the call. IMPORTANT SAFETY INFORMATION WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTSIBSRELA is contraindicated in patients less than 6 years of age; in nonclinical studies in young juvenile rats administration of tenapanor caused deaths presumed to be due to dehydration. Avoid use of IBSRELA in patients 6 years to less than 12 years of age. The safety and effectiveness of IBSRELA have not been established in patients less than 18 years of age. CONTRAINDICATIONS IBSRELA is contraindicated in patients less than 6 years of age due to the risk of serious dehydration.IBSRELA is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction. WARNINGS AND PRECAUTIONSRisk of Serious Dehydration in Pediatric Patients IBSRELA is contraindicated in patients below 6 years of age. The safety and effectiveness of IBSRELA in patients less than 18 years of age have not been established. In young juvenile rats (less than 1 week old; approximate human age equivalent of less than 2 years of age), decreased body weight and deaths occurred, presumed to be due to dehydration, following oral administration of tenapanor. There are no data available in older juvenile rats (human age equivalent 2 years to less than 12 years).Avoid the use of IBSRELA in patients 6 years to less than 12 years of age. Although there are no data in older juvenile rats, given the deaths in younger rats and the lack of clinical safety and efficacy data in pediatric patients, avoid the use of IBSRELA in patients 6 years to less than 12 years of age. Diarrhea Diarrhea was the most common adverse reaction in two randomized, double-blind, placebo-controlled trials of IBS-C. Severe diarrhea was reported in 2.5% of IBSRELA-treated patients. If severe diarrhea occurs, suspend dosing and rehydrate patient. MOST COMMON ADVERSE REACTIONS The most common adverse reactions in IBSRELA-treated patients (incidence ≥2% and greater than placebo) were: diarrhea (16% vs 4% placebo), abdominal distension (3% vs <1%), flatulence (3% vs 1%) and dizziness (2% vs <1%). INDICATION IBSRELA (tenapanor) is indicated for the treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in adults. Please see full Prescribing Information, including Boxed Warning, for additional risk information. About Ardelyx, Inc.Ardelyx was founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs. Ardelyx’s first approved product, IBSRELA® (tenapanor) is available in the United States and Canada. Ardelyx is developing XPHOZAH® (tenapanor), a novel product candidate for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis, which has completed three successful Phase 3 trials. Ardelyx has a Phase 2 potassium lowering compound, RDX013, for the potential treatment of elevated serum potassium, or hyperkalemia, a problem among certain patients with kidney and/or heart disease and an early-stage program in metabolic acidosis, a serious electrolyte disorder in patients with CKD. Ardelyx has established agreements with Kyowa Kirin in Japan, Fosun Pharma in China and Knight Therapeutics in Canada for the development and commercialization of tenapanor in their respective territories. For more information, please visit https://ardelyx.com/ and connect with us on Twitter, LinkedIn and Facebook. Forward Looking Statements To the extent that statements contained in this press release are not descriptions of historical facts regarding Ardelyx, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor of the Private Securities Reform Act of 1995, including Ardelyx’s expectation regarding opportunities for continued IBSRELA adoption, Ardelyx’s expectation for the timing of receipt from FDA of the classification of the NDA for XPHOZAH and the goal review date for the NDA, as well as the current expectation for the timing of the launch of XPHOZAH, if approved, and the potential for Ardelyx to receive regulatory and sales milestone and royalty revenue from it collaboration partner, METiS Therapeutics. Such forward-looking statements involve substantial risks and uncertainties that could cause Ardelyx's future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, uncertainties associated with the development of, regulatory process for, and commercialization of drugs in the U.S. and internationally. Ardelyx undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Ardelyx's business in general, please refer to Ardelyx's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 3, 2023, and its future current and periodic reports to be filed with the Securities and Exchange Commission. Investor and Media Contacts: Caitlin Lowieclowie@ardelyx.com Kimia Keshtbod kkeshtbod@ardelyx.com Ardelyx, Inc.Condensed Balance Sheets(In thousands) March 31, 2023 December 31, 2022 (Unaudited) (1) Assets Cash and cash equivalents$ 92,487 $ 96,140 Investments 37,886 27,769 Accounts receivable 12,120 7,733 Prepaid commercial manufacturing 13,835 13,567 Inventory, current 4,823 3,282 Inventory, non-current 40,124 25,064 Property and equipment, net 1,102 1,223 Right-of-use assets 7,972 9,295 Prepaid and other assets 6,670 5,993 Total assets$ 217,019 $ 190,066 Liabilities and stockholders' equity Accounts payable$ 10,513 $ 10,859 Accrued compensation and benefits 5,074 7,548 Current portion of operating lease liability 3,998 3,894 Current portion of long-term debt 26,880 26,711 Deferred revenue 17,043 13,236 Accrued expenses and other liabilities 11,053 12,380 Operating lease liability, net of current portion 4,814 5,855 Deferred royalty obligation related to the sale of future royalties 12,223 11,254 Stockholders' equity 125,421 98,329 Total liabilities and stockholders' equity$ 217,019 $ 190,066 (1) Derived from the audited financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022. Ardelyx, Inc.Condensed Statements of Operations(Unaudited)(In thousands, except share and per share amounts) Three Months Ended March 31, 2023 2022 Revenues: Product sales, net$11,355 $450 Product supply revenue 2 14 Licensing revenue 12 4 Total revenues 11,369 468 Operating expenses: Cost of revenue 1,537 85 Research and development 9,093 8,851 Selling, general and administrative 26,803 19,339 Total operating expenses 37,433 28,275 Loss from operations (26,064) (27,807)Interest expense (1,028) (746)Non-cash interest expense related to the sale of future royalties (969) — Other income, net 1,302 484 Loss before provision for income taxes (26,759) (28,069)Provision for income taxes 14 2 Net loss$(26,773) $(28,071)Net loss per share of common stock - basic and diluted$(0.13) $(0.21)Shares used in computing net loss per share - basic and diluted 207,023,127 130,934,795