Pomotrelvir

CARLSBAD, Calif., May 05, 2023 (GLOBE NEWSWIRE) -- Pardes Biosciences, Inc. (NASDAQ: PRDS) today reported financial results for the first quarter ended March 31, 2023. “As previously announced this year, Pardes Biosciences has initiated a process to evaluate strategic alternatives to maximize shareholder value that may potentially result in changes to our business strategy,” said Thomas G. Wiggans, Chief Executive Officer and Chair of Pardes Biosciences. First Quarter 2023 Financial Results Pardes reported a net loss of $17.8 million for the three months ended March 31, 2023, as compared to a net loss of $21.4 million for the three months ended March 31, 2022. Decrease in net loss for the reporting period was primarily driven by decreases in professional fees related to legal fees and pre-commercial planning and an increase of interest income, offset by an increase in personnel expenses, including $1.1 million in recognized severance expense associated with the announced reduction in force (RIF) and stock-based compensation. Research and development expenses were $13.0 million for the three months ended March 31, 2023, compared to $13.2 million for the three months ended March 31, 2022, a decrease of $0.2 million. The decrease was primarily driven by the suspension of next generation and discovery programs while we advanced pomotrelvir, offset by higher pomotrelvir costs and personnel costs, including stock-based compensation. As a result of our decision to suspend clinical development of pomotrelvir and winddown all research and development activities, we anticipate that our research and development expenses, excluding costs associated with the RIF, will decrease in the near term pending any decision related to our review of strategic alternatives. General and administrative expenses were $6.8 million for the three months ended March 31, 2023, compared to $8.2 million for the three months ended March 31, 2022, a decrease of $1.4 million. The decrease was primarily due to decreases in professional fees related to legal fees and pre-commercial planning. We anticipate that our general and administrative expenses, excluding costs associated with the RIF, will continue to decrease in the near term as we decrease our headcount, pursuant to the RIF. Additionally, depending on the outcome of our ongoing strategic alternative review process, including the extent to which we identify and enter into any potential strategic transaction, there may be an increase in general and administrative expenses in the future. Pardes’ cash, cash equivalents and short-term investments as of March 31, 2023, were $172.2 million compared to $197.3 million as of December 31, 2022. The company expects that the cash and cash equivalents on hand as of March 31, 2023, will be sufficient to fund our current planned operations for the next 12 months. As of April 30, 2023, Pardes' preliminary cash, cash equivalents and short-term investments totaled approximately $168.2 million. The results for the quarter-to-date period are preliminary and are not necessarily indicative of the results that may be expected for the full quarter ending June 30, 2023 or any other period. In addition, during the course of the preparation of Pardes' results for the three months ending June 30, 2023, additional adjustments to this preliminary financial data may be identified. Any such adjustments may be material. Therefore, actual financial results that will be reflected in Pardes' Quarterly Report on Form 10-Q for the three months ended June 30, 2023 when they are completed and publicly disclosed may differ from the preliminary results presented here. About Pardes Biosciences, Inc. Pardes Biosciences is a biopharmaceutical company that has been focused on discovering, developing and commercializing novel oral anti-viral therapeutics to improve the lives of patients suffering from life-threatening disease, starting with COVID-19. For more information, please visit www.pardesbio.com. 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. Forward Looking Statement 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 “believe,” “intend,” “may,” “plan,” “possible,” “predict,” “should,” “will,” and similar expressions and their variants, as they relate to the Company, may identify forward-looking statements. All statements that reflect Pardes Biosciences’ (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 preliminary cash, cash equivalents and short-term investments as of April 30, 2023, statements regarding Pardes' intent to review strategic alternatives and Pardes' expectation that general and administrative expenses will decrease. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks associated with: the completion of the quarterly review of the Company’s financial statements for the quarter ended June 30, 2023; volatility and uncertainty in the capital markets for biopharmaceutical companies; Pardes' ability to execute its planned exploration and evaluation of strategic alternatives; availability of suitable third parties with which to conduct contemplated strategic transactions; whether the Company will be able to pursue a strategic transaction, or whether any transaction, if pursued, will be completed on attractive terms or at all; whether Pardes' plans will provide the intended benefits and cost savings; and 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, Quarterly Report on Form 10-Q to be filed for the quarter ended March 31, 2023, and other filings subsequently filed with the U.S. Securities and Exchange Commission. 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. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. Investor Contact: ir@pardesbio.com Select Financial Information: Pardes Biosciences, Inc. Condensed Statements of Operations (Unaudited) (in thousands, except share and per share amounts) Three Months Ended March 31, 2023 2022 Operating expenses: Research and development $12,980 $13,199 General and administrative 6,829 8,226 Total operating expenses 19,809 21,425 Other income: Interest and other income, net 2,004 (15)Net loss $(17,805) $(21,440)Net loss per share, basic and diluted $(0.30) $(0.38)Weighted-average number of common shares - basic and diluted 59,766,037 57,039,069 Pardes Biosciences, Inc. Condensed Balance Sheets (Unaudited) (in thousands) March 31, December 31, 2023 2022 Assets Current assets: Cash and cash equivalents $47,164 $59,284 Short-term investments 125,067 138,056 Prepaid expenses and other current assets 3,914 3,062 Total current assets 176,145 200,402 Other assets — 219 Total assets $176,145 $200,621 Liabilities and stockholders' equity Current liabilities: Accounts payable $3,715 $4,929 Accrued expenses 7,700 15,496 Total current liabilities 11,415 20,425 Total liabilities 11,415 20,425 Stockholders' equity: Preferred stock — — Common stock 6 6 Additional paid-in capital 330,710 328,372 Accumulated other comprehensive loss (23) (24)Accumulated deficit (165,963) (148,158)Total stockholders' equity 164,730 180,196 Total liabilities and stockholders' equity $176,145 $200,621

Covid-19 antibody drug developers have had a rough time. One by one, antibody medicines that reached the market under emergency use saw their authorized indications narrowed and then revoked by the FDA due to ineffectiveness against newer strains of the virus. By the end of last year, no Covid-19 antibody drugs remained authorized for use in the U.S. InflaRx is showing that Covid-19 antibody drug research is still alive. The FDA this week authorized the biotech’s antibody, vilobelimab, as a treatment for Covid-19 in hospitalized adults. The drug is meant for severe cases. The authorization specifies treatment must start within 48 hours of the patient receiving mechanical ventilation or artificial life support. Jena, Germany-based InflaRx will market its new product under the name “Gohibic.” The antibody drugs whose authorizations were revoked all targeted some part of SARS-CoV-2 in order to prevent it from infecting cells. InflaRx’s target isn’t on the virus. The biotech’s antibody addresses a part of the immune response believed to play a role in the inflammation that leads to Covid-19 progression. The drug targets C5a, a protein of the complement system, which is a part of the immune system. Authorization of InflaRx’s drug provides an alternative to Olumiant, an Eli Lilly drug. Like Gohibic, Olumiant is also authorized for treating hospitalized patients within 48 hours of starting mechanical ventilation or artificial life support. This Lilly drug works by blocking JAK proteins associated with inflammation. But Olumiant is a small molecule made into a pill—a challenging formulation for patients receiving breathing assistance. Olumiant can be dissolved in water and swallowed or administered via a gastrointestinal tube. But InflaRx’s Gohibic provides yet another dosing option, as that drug is administered as an intravenous infusion. InflaRx initially developed its antibody as a treatment for hidradenitis suppurativa, a rare inflammatory skin disorder. In 2019, the antibody drug failed a Phase 2b test in that indication. With the onset of the pandemic the following year, InflaRx began a clinical trial testing the antibody in Covid-19 patients. The Gohibic EUA request was based on data from a placebo-controlled Phase 3 study that enrolled 369 mechanically ventilated patients in intensive care units. According to study results, after 28 days, the treatment group showed a 23.9% reduction in death from all causes compared to the placebo arm. The most common adverse reactions reported in the study included pneumonia, sepsis, delirium, and pulmonary embolism. The FDA also said serious infections have been reported in Covid-19 patients who received Gohibic. Now that InflaRx has emergency authorization for Gohibic, the company said it is communicating with the FDA about the next steps for a biologics license application seeking full regulatory approval. The company is having similar discussions with regulators in Europe. Pardes Explores Strategic Alternatives After Antiviral Fails Phase 2 Meanwhile, it looks like the end of the road for another Covid-19 biotech company, Pardes Biosciences. Carlsbad, California-based Pardes this week reported data showing its antiviral drug, pomotrelvir, did not meet the main goal of a Phase 2 study. Pomotrelvir is a small molecule designed to inhibit main protease, or Mpro, the same viral enzyme addressed by the authorized Pfizer Covid-19 drug Paxlovid. It must be taken with another medicine that slows the breakdown of Paxlovid, keeping it in the body for longer and at higher concentrations. But this drug regimen requires patients to take extra pills. Pardes aimed to bring patients the benefits of blocking Mpro without the need for additional pills to help its drug work better. The placebo-controlled Phase 2 test enrolled 242 adults with mild-to-moderate Covid-19. The main goal was to measure the proportion of trial participants who reached undetectable viral levels. According to the preliminary results, 70% of patients in the treatment arm achieved that mark compared to 63% in the placebo group—not enough to be meaningful. Pardes is continuing to analyze the results, which it said will be submitted to a scientific conference or peer-reviewed publication to contribute to the field’s understanding of SARS-CoV-2 and the development of Covid-19 drugs. Given the Phase 2 failure, Pardes is stopping further clinical development of pomotrelvir and it has begun a review of strategic alternatives that could include an acquisition or a merger with another company. As is typical of companies undergoing such reviews, Pardes said it would not comment unless or until its board of directors has determined a course of action. In a regulatory filing, Pardes said it is laying off 85% of its workforce in phases, starting this month. The estimated costs associated with layoffs is $5.7 million. As of the end of the first quarter of this year, Pardes reported its cash position was $172.4 million. Image: appledesign, Getty Images