cysteine protease

STOCKHOLM, April 25, 2024 /PRNewswire/ -- Medivir AB (NASDAQ: MVIR) (STO: MVIR) , a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, announced today that its selective cathepsin K inhibitor, MIV-711, has been granted Rare Pediatric Disease Designation (RPDD) as well as Orphan Drug Designation (ODD) for the treatment of Legg-Calvé-Perthes Disease (LCPD). The FDA defines a rare pediatric disease as a serious or life-threatening disease in which the disease manifestations primarily affect individuals aged from birth to 18 years of age. Pediatric diseases recognized as "rare", affect fewer than 200,000 people in the United States. With a RPDD, MIV-711 qualifies to receive fast track review and upon marketing approval in LCPD, the Company may be eligible to receive a Priority Review Voucher from the FDA. The voucher can be redeemed to receive priority review for any subsequent marketing application or may be sold to another company for their use. - "LCPD is a disease, with a significant impact on daily life as well as risk for long-term sequalae, for which there are no available effective treatments. Children with LCPD are more likely to suffer from obesity and depression due to the forced immobility as a consequence of the disease. In more than half of the children, the affected leg becomes shorter than the healthy leg and about 50% end up with a deformed hip joint where ultimately osteoarthritis develops. We are delighted that MIV-711 has been granted RPDD by the FDA with the potential to become the first approved treatment option. We see partnership as an attractive way to move forward with MIV-711 to ensure speed of development," said Jens Lindberg, CEO of Medivir. To gain RPDD, there must be supportive data suggesting that the drug may be effective in the disease. MIV-711 has shown, in an LCPD-specific animal model, the ability to prevent femoral head deformity and positive impact on biomarker of bone degradation without negatively impacting normal bone formation. Similarly, clinical studies have shown that MIV-711 prevents bone degradation in patients with osteoarthritis, further supporting the potential clinical benefit in LCDP. Cathepsin K is the main cysteine protease involved in bone resorption and cartilage degradation by osteoclasts, through the breakdown of key bone matrix proteins. Cathepsin K inhibition protects the damaged bone by reducing bone resorption and promoting bone formation, thereby addressing the key mechanisms causing pathological changes in LCPD, with potential to minimize long-term negative effects. Selective inhibition of cathepsin K has the potential to provide clinical benefit in diseases characterized by excessive bone resorption, including additional pediatric bone disorders. For additional information, please contact: Magnus Christensen, CFO, Medivir AB Telephone: +46 8 5468 3100. E-mail: [email protected] About Legg-Calvé-Perthes Disease Legg-Calvé-Perthes disease (LCPD) is a childhood hip disorder initiated by a disruption of blood flow to the head of the femur. Due to the lack of blood flow, the bone dies (osteonecrosis or avascular necrosis) and stops growing. Over time, healing occurs by new blood vessels infiltrating the dead bone and removing the necrotic bone which leads to a loss of bone mass and a weakening of the femoral head. The condition is most commonly found in children between the ages of 4 and 8, but it can occur in children between the ages of 2 and 15. It is estimated to affect about 10 in 100.000 children per year in the USA. It results in permanent deformity of the femoral head in many children, which increases the risk of developing osteoarthritis in adults. About MIV-711 MIV-711 is a potent and selective inhibitor of cathepsin K, the principal protease involved in breaking down collagen in bone and cartilage. It has been shown to slow, stop or reverse the progressive degeneration of joints affected by osteoarthritis. By inhibiting cathepsin K and increased/excessive activity of osteoclasts, MIV-711 has the potential to prevent degradation of bone and cartilage and counteract the osteonecrosis induced by lack of blood flow, to prevent femoral head deformity and long-term negative effects as well as positively impact Quality of Life. About Medivir Medivir develops innovative drugs with a focus on cancer where the unmet medical needs are high. The drug candidates are directed toward indication areas where available therapies are limited or missing and there are great opportunities to offer significant improvements to patients. Medivir is focusing on the development of fostroxacitabine bralpamide (fostrox), a smart, targeted chemotherapy designed to selectively treat liver cancer cells and to minimize side effects. Collaborations and partnerships are important parts of Medivir's business model, and the drug development is conducted either by Medivir or in partnership. Medivir's share (ticker: MVIR) is listed on Nasdaq Stockholm's Small Cap list. . This information was brought to you by Cision The following files are available for download: SOURCE Medivir

Data from ongoing Phase 2 trial evaluating pomotrelvir (formerly known as PBI-0451) for the treatment of COVID-19 expected in the coming weeks Cash to fund operations for the next twelve months CARLSBAD, Calif., March 14, 2023 (GLOBE NEWSWIRE) -- Pardes Biosciences, Inc. (NASDAQ: PRDS), a clinical-stage biopharmaceutical company developing pomotrelvir as a potential stand-alone novel direct-acting, oral antiviral drug candidate for the treatment of COVID-19, today reported financial results for the fourth quarter and full year ended December 31, 2022 and provided a business update. “We are greatly encouraged by the progress made in our ongoing Phase 2 study evaluating pomotrelvir for the treatment of COVID-19, and we continue to believe in its potential to fulfill the unmet demand for a stand-alone, oral antiviral treatment that is safe, easy-to-prescribe, and designed for broad patient use, including those facing challenges with currently available therapies,” said Thomas G. Wiggans, Chief Executive Officer and Chair of the Board of Directors for Pardes Biosciences. “We are excited and remain on track to share the results from this study in the coming weeks and feel well positioned to rapidly advance this program into its next stage of development and to patients in need.” Fourth Quarter and Full Year 2022 Financial Results Pardes reported a net loss of $24.2 million and $96.6 million for the three months and full year ended December 31, 2022, respectively, as compared to a net loss of $14.3 million and $38.5 million for the three months and full year ended December 31, 2021, respectively. Net loss for the reporting period was driven by an increase in research and development expenses, as well as increased costs related to the infrastructure needed to support Pardes’ growth and transition to operating as a public company. Research and development expenses were $19.4 million for the quarter ended December 31, 2022, compared to $10.4 million for the quarter ended December 31, 2021, an increase of $9.0 million. Research and development expenses were $70.4 million for the full year ended December 31, 2022, compared to $28.2 million for the full year ended December 31, 2021, an increase of $42.2 million. These increases were primarily driven by increased costs related to advancing our lead product candidate, pomotrelvir, into the clinic and higher personnel costs, including stock-based compensation, as we have grown our organization. General and administrative expenses were $6.7 million for the quarter ended December 31, 2022, compared to $3.9 million for the quarter ended December 31, 2021, an increase of $2.8 million. General and administrative expenses were $29.5 million for the full year ended December 31, 2022, compared to $10.3 million for the full year ended December 31, 2021, an increase of $19.2 million. These increases were due to increased personnel costs, including stock-based compensation, increased professional fees related to legal, pre-commercial planning and consulting services, and costs associated with being a public company, including directors’ and officers’ insurance and compliance fees. Pardes’ cash, cash equivalents and short-term investments as of December 31, 2022, were $197.3 million compared to $209.1 million as of September 30, 2022. The company expects that the cash and cash equivalents and short-term investments on hand as of December 31, 2022, will be sufficient to fund operating expenses and capital expenditures for the next twelve months. About Pardes Biosciences, Inc. Pardes Biosciences is a clinical-stage biopharmaceutical company created to help solve pandemic-sized problems, starting with COVID-19. We are dedicated to discovering and developing potent and easy-to-prescribe oral antiviral drug candidates so that patients everywhere can get well sooner. For more information, please visit www.pardesbio.com. About Pomotrelvir Pomotrelvir (formerly known as PBI-0451) is a potential stand-alone, novel, direct-acting oral antiviral drug candidate for the treatment of COVID-19 that is in Phase 2 clinical development (NCT 05543707). Pomotrelvir was developed to inhibit the main cysteine protease (Mpro) of all known coronaviruses, including SARS-CoV-2. Inhibiting Mpro prevents the liberation and assembly of the viral replication complex, blocking replication before it begins. The potent antiviral activity observed across SARS-CoV-2 variants in preclinical in vitro studies as well as the favorable safety and tolerability data from Pardes Biosciences’ Phase 1 clinical trials support continued clinical development of pomotrelvir, which we believe has the potential to be a safe, effective and easy-to-prescribe oral antiviral for treating COVID-19 in adult and pediatric patients, including patients unable or unwilling to take currently authorized or approved therapies. About COVID-19 COVID-19 has resulted in an unprecedented and persistent global health emergency. Over three years into the pandemic, COVID-19 remains a leading cause of death in the U.S., with greater than 6.8 million deaths worldwide and millions of newly documented cases monthly1. As the long-term implications of on-going waves, repeated SARS-CoV-2 infection and “long COVID” become increasingly clear, the infectivity and mutability of SARS-CoV-2 represents a substantial clinical and economic burden for years to come. New therapeutics are urgently needed to address future variants and provide options for the millions of patients unable or unwilling to take currently authorized or approved therapeutics. Existing treatment options are unfortunately being eliminated or falling short due to lack of efficacy against new variants, safety concerns, significant drug-drug interactions, risk of viral rebound, limited access, and other factors. Notably, the most commonly prescribed oral therapy in the U.S. is contraindicated with dozens of common medications, leaving millions of patients with high unmet medical need vulnerable to disease progression. Over 80% of adults over 60 are on at least 1 other medicine and over 30% are taking at least 5 other medicines.2 Many of these common, contraindicated drug classes should not be paused (e.g., blood thinners, antipsychotics, antidepressants and antiarrhythmics). These patients are at high risk of severe disease and left with unacceptable alternatives. New therapeutics are urgently needed to address this need, prepare for future variants, and advance care for all patients. Availability of Other Information about Pardes Biosciences Pardes Biosciences intends to use the Investors page of its website (https://ir.pardesbio.com) as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD. Accordingly, investors should monitor Pardes Biosciences’ Investors website, in addition to following Pardes Biosciences’ press releases, Securities and Exchange Commission (SEC) filings, public conference calls, presentations and webcasts. 1 https://www.kff.org/coronavirus-covid-19/issue-brief/global-covid-19-tracker/ 2 https://www-cdc-gov.libproxy1.nus.edu.sg/nchs/data/databriefs/db347-h.pdf Forward Looking Statements This press release contains statements that relate to future events and expectations and, as such, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. When or if used in this press release, the words “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “outlook,” “plan,” “possible,” “predict,” “should,” “will,” and similar expressions and their variants, as they relate to Pardes Biosciences (Pardes), may identify forward-looking statements. All statements that reflect Pardes’ expectations, assumptions or projections about the future, other than statements of historical fact, are forward-looking statements, including, without limitation, statements regarding the company’s future financial or business performance, conditions, plans, prospects, trends or strategies and other financial and business matters, including expectations that its current cash and cash equivalents and short-term investments on hand as of December 31, 2022, will be sufficient to fund operating expenses and capital expenditures for the next twelve months; pomotrelvir’s potential as a safe, well-tolerated and easy to prescribe COVID-19 oral antiviral treatment for all patients; the potential advancement of pomotrelvir into later staged clinical trials; and the timing on the availability of data from the Phase 2 clinical trial. Forward-looking statements reflect Pardes’ current beliefs, expectations, and assumptions regarding the future of its business, its future plans and strategies, its development plans, its preclinical and clinical results, future conditions and other factors Pardes believes are appropriate in the circumstances. Although Pardes believes the expectations and assumptions reflected in such forward-looking statements are reasonable, Pardes can give no assurance that they will prove to be correct. Forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and changes in circumstances that are difficult to predict, which could cause Pardes’ actual activities and results to differ materially from those expressed in any forward-looking statement. Such risks and uncertainties include, but are not limited to: (i) risks and uncertainties related to Pardes’ ability to advance, obtain regulatory approval of and ultimately commercialize its product candidates; (ii) the timing and results of preclinical studies and clinical trials; (iii) Pardes’ ability to maintain financial resources necessary to continue its clinical trials and fund development goals and business operations; (iv) the impact of the COVID-19 pandemic on Pardes’ business, clinical trials, financial condition, liquidity and results of operations; (v) Pardes’ ability to protect its intellectual property; and (vi) other risks and uncertainties described under the heading “Risk Factors” in Pardes’ Annual Report on Form 10-K for the year ended December 31, 2022 and other SEC filings. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. The statements in this press release speak only as of the date of this press release, even if subsequently made available by Pardes on its website or otherwise. Pardes disclaims any intention or obligation to update publicly any forward-looking statements, whether in response to new information, future events, or otherwise, except as required by applicable law. Investor Contacts: Patrick O'Brien pobrien@pardesbio.com Select Financial Information: Pardes Biosciences, Inc.Condensed Statements of Operations(Unaudited)(in thousands, except share and per share amounts) Three Months Ended December 31, Year Ended December 31, 2022 2021 2022 2021 Operating expenses: Research and development $19,432 $10,360 $70,350 $28,152 General and administrative 6,731 3,947 29,467 10,336 Total operating expenses 26,163 14,307 99,817 38,488 Other income: Interest and other income, net 1,941 (20) 3,183 (30)Net loss $(24,222) $(14,327) $(96,634) $(38,518)Net loss per share, basic and diluted $(0.41) $(1.60) $(1.66) $(10.13)Weighted-average number of common shares - basic and diluted 59,334,504 8,965,699 58,127,385 3,800,506 Pardes Biosciences, Inc.Condensed Balance Sheets(Unaudited)(in thousands) December 31, December 31, 2022 2021 Assets Current assets: Cash and cash equivalents $59,284 $268,678 Short-term investments 138,056 — Prepaid expenses and other current assets 3,062 6,581 Total current assets 200,402 275,259 Other assets 219 — Total assets $200,621 $275,259 Liabilities and stockholders' equity Current liabilities: Accounts payable $4,929 $2,385 Accrued expenses 15,496 6,580 Total current liabilities 20,425 8,965 Total liabilities 20,425 8,965 Stockholders' equity: Preferred stock — — Common stock 6 6 Additional paid-in capital 328,372 317,812 Accumulated other comprehensive loss (24) — Accumulated deficit (148,158) (51,524)Total stockholders' equity 180,196 266,294 Total liabilities and stockholders' equity $200,621 $275,259

CARLSBAD, Calif., Sept. 13, 2022 (GLOBE NEWSWIRE) -- Pardes Biosciences, Inc. (Nasdaq: PRDS), a clinical-stage biopharmaceutical company developing PBI-0451 as a potential stand-alone, novel direct-acting, oral antiviral drug candidate for the treatment and prevention of SARS-CoV-2 infections and associated diseases (i.e., COVID-19), today reported commencement of a Phase 2 double-blind, randomized study to evaluate the antiviral activity, safety, and efficacy of orally administered PBI-0451 compared with placebo in non-hospitalized symptomatic adults with COVID-19 who are not at increased risk of progressing to severe illness. Pardes Biosciences expects to enroll 210 patients in the Phase 2 clinical trial at approximately 75 sites within the United States. Study eligibility will include symptoms of COVID-19 for 5 or less days and a positive test for SARS-CoV-2 infection. Use of concomitant medications for underlying health conditions will not be restricted in the clinical trial. Participants will be administered PBI-0451 orally with food, twice daily, at a 700 mg (2x 350 mg tablets) dose or placebo over five days. The primary objective will be to determine the proportion of patients below the limit of detection in nasal swab samples for infectious SARS-CoV-2 on day three. Secondary objectives will include assessments of safety and tolerability, time to sustained clinical recovery through day 28 defined as key COVID-19 symptoms, and hospitalizations and deaths. “Initiation of our PBI-0451 Phase 2 study marks a significant step towards our goal of bringing a self-administered, oral, well-tolerated and easy-to-use COVID-19 treatment option to a broad patient population due to a unique, favorable drug-drug interaction profile,” said Tom Wiggans, Chief Executive Officer and Chair of Pardes Biosciences. “PBI-0451 has the potential to be a stand-alone SARS-CoV-2 protease inhibitor that can be easily prescribed and administered to alleviate the burden of COVID-19 to patients and healthcare systems. We look forward to evaluating PBI-0451 in this broad patient population and sharing preliminary results in the first quarter of 2023.” In a Phase 1 clinical trial, PBI-0451 at single and multiple doses demonstrated favorable tolerability without any study drug discontinuations and there were no treatment emergent drug-related adverse events assessed as greater than mild in severity. Additionally, no direct drug-related adverse findings were observed in 14-day or 28-day toxicology studies conducted across multiple preclinical species. PBI-0451 does not require ritonavir boosting and has the potential to be used broadly due to a favorable drug-drug interaction profile. About Pardes Biosciences, Inc. Pardes Biosciences is a clinical-stage biopharmaceutical company created to help solve pandemic-sized problems, starting with COVID-19. We are dedicated to discovering and developing potent and easy-to-prescribe oral antiviral drug candidates so that patients everywhere can get well sooner. For more information, please visit www.pardesbio.com. About PBI-0451 PBI-0451 is a potential stand-alone, novel, direct-acting oral antiviral drug candidate for the treatment and prevention of SARS-CoV-2 infections in Phase 2 clinical development. PBI-0451 was developed to inhibit the main cysteine protease (Mpro) of all known coronaviruses, including SARS-CoV-2. Inhibiting Mpro prevents the liberation and assembly of the viral replication complex, blocking replication before it begins. The potent antiviral activity observed across SARS-CoV-2 variants in preclinical in vitro studies as well as the favorable safety and tolerability data from Pardes Biosciences’ first-in-human Phase 1 clinical trial (Study PBI-0451-0001, NCT 05011812) support continued clinical development of PBI-0451, which it believes has the potential to be a safe, effective and easy-to-prescribe oral antiviral for preventing and treating SARS-CoV-2 infections, including patients unable or unwilling to take currently authorized or approved therapies. Availability of Other Information about Pardes Biosciences Pardes Biosciences intends to use the Investors page of its website (https://ir.pardesbio.com) as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD. Accordingly, investors should monitor Pardes Biosciences’ Investors website, in addition to following Pardes Biosciences’ press releases, Securities and Exchange Commission (SEC) filings, public conference calls, presentations and webcasts.