METiS Therapeutics, Inc.

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Metis Therapeutics, a Boston-area company integrating drug discovery and delivery with AI and machine learning, today announced they have entered a license agreement with Voronoi, Inc., a Korean company focused on precision medicine. Under the terms of this license agreement, METiS will receive exclusive license to develop and commercialize Voronoi’s pan-RAF inhibitor program worldwide. In exchange, Voronoi will receive up to $1.7 million in upfront cash and success-based near-term discovery milestones. Voronoi will also be eligible for success-based payment up to $480.5 million in development, regulatory and sales milestones and tiered royalties based on annual net sales. “We view this program as a potential best-in-class asset addressing high unmet clinical needs for Class II and Class III BRAF mutant cancer patients, particularly those with CNS metastasis,” said Chris Lai, Co-Founder and CEO of METiS Therapeutics. “We see it as a compelling proof-of-concept opportunity for our AiTEM platform to improve compound pharmacokinetics and deliver a differentiated profile, including CNS penetration. In addition, we view this as a foundational asset for our oncology portfolio.” BRAF is a protein kinase involved in cancer cell growth and BRAF mutations are the most common mutation found in tumor cells1. While several BRAF v600E inhibitors have been approved, this mutation only represents about 45% of total BRAF mutations, compared to Class II and III mutations which represent 55 percent of total BRAF mutations. This underscores the need for new therapeutic options in this space. “We developed our structurally distinguished type II pan-RAF inhibitor to address unmet medical needs, and this partnership brings us closer to our goal of delivering this candidate to patients,” says Daekwon Kim, CEO of Voronoi. “We are excited to partner with METiS’ seasoned team to continue on development of our pan-RAF inhibitor,” added Daekwon. This news follows METiS’ announcement that the company had joined the Roche Accelerator earlier this year. In December, METiS closed an $86 million Series A financing round. The company recently leased 14,000 square feet of mixed office and laboratory space at 101 Cambridgepark Drive in Cambridge, MA. About METiS METiS is a biotechnology company that aims to drive best-in-class therapies in a wide range of disease areas by integrating drug discovery and delivery with AI, machine learning, and quantum simulation. To learn more, please visit metistx.com. 1 MEK and BRAF inhibitors plus other melanoma targeted therapies. Memorial Sloan Kettering Cancer Center. (n.d.). Retrieved August 29, 2022, from

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