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Pfizer is expanding its multibillion-dollar cost-cutting effort that began in 2023, announcing $1.7 billion in new planned reductions. The new round of cuts disclosed Tuesday is part of Pfizer’s “cost realignment” program, with $1.2 billion in net cost savings primarily affecting selling, information and administrative work through 2027. The company said in its announcement that those savings were driven “by enhanced digital enablement, including automation and AI, and simplification of business processes.” An additional $500 million in R&D reductions are now expected through 2026, though the company says it will reinvest that money back into the pipeline. The first phase of a separate $1.5 billion savings effort associated with manufacturing work is still ongoing through 2027. Pfizer says the total size of both the cost-realignment and manufacturing optimization programs is $7.7 billion. It’s the third time that Pfizer has updated the expected total of its cost-realignment measures, after they were first unveiled in October 2023. The $3.5 billion in expected savings grew to $4 billion before the end of 2023, and Pfizer disclosed another $500 million in expected 2025 savings at the end of last year. The manufacturing-specific effort was announced in May 2024. Pfizer announced the cuts as part of its first-quarter earnings results, where it reaffirmed its prior guidance of $61 billion to $64 billion in sales for the full year. It also stood by its full-year 2025 adjusted earnings per share of $2.80 to $3.00. Projecting and maintaining financial stability are welcome news for investors, but key questions about Pfizer’s pipeline, particularly in obesity, remain. Pfizer had pinned its near-term hopes on its oral obesity drug danuglipron, but that asset sputtered in early studies and was shelved by the company earlier this month. Pfizer reported then that one patient in its clinical trials for the GLP-1 agonist reported a case of liver injury that may have been tied to the drug. The pharma previously deprioritized a twice-daily form of the drug after safety issues arose. Pfizer’s setbacks in the obesity space were among the reasons why activist investor Starboard Value took up a $1 billion stake in the company last year. The firm broadly criticized Pfizer’s dealmaking strategy and pointed to obesity as a market where the company was failing to execute. CEO Albert Bourla said in prepared remarks ahead of Tuesday’s call that with the shelving of danuglipron, Pfizer would advance internal programs and pursue “external opportunities that could include partnerships or acquisitions.” One such internal program, GLP-1R agonist PF-06954522, had its indication swapped from diabetes to chronic weight management. The asset is currently in Phase 1 studies. Pfizer culled six other programs in the first quarter beyond danuglipron, including expanding Ngenla’s label to include adults. The human growth hormone agonist is approved to treat kids. A spokesperson for Pfizer did not immediately respond to a request for comment on the Ngenla decision or the plans for the GLP-1R agonist. Editor’s note: This story was updated with additional pipeline information and corrected Pfizer’s full-year revenue guidance.

Data Show Tesamorelin May Reduce CVD Risk by Reducing EVAFMONTREAL, Oct. 17, 2024 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on development and commercialization of innovative therapies, today announced data from two poster presentations, focusing on the association between excess visceral abdominal fat (EVAF) and cardiovascular disease (CVD) risk in people with HIV (PWH), and on the use of tesamorelin to reduce such risk. In a poster presentation at IDWeek 2024 in Los Angeles, Calif., investigators from the Visceral Adiposity Measurement and Observations Study (VAMOS) reported that EVAF is one of several risk factors that contribute to heightened CVD risk in PWH who are on modern anti-retroviral therapy (ART) regimens. In a separate poster presentation, researchers demonstrated that the EVAF-lowering properties of tesamorelin, a growth hormone-releasing factor (GHRF), enable a reduction in CVD risk in PWH. “The two studies presented at IDWeek 2024 suggest that excess visceral abdominal fat is an overlooked risk factor for cardiovascular disease in people with HIV, and that use of tesamorelin for visceral abdominal fat reduction may contribute to lowering cardiovascular disease risk,” said Christian Marsolais, Ph.D., Senior Vice President and Chief Medical Officer of Theratechnologies. “We hope greater awareness of EVAF, and of strategies to address this risk factor, lead to improved outcomes in people with HIV being treated with ART medicines.” VAMOS Data VAMOS, a cross-sectional, multicenter observational study, is the first trial designed to improve the understanding of the impact of EVAF on CVD, steatotic liver disease, insulin resistance, and other metabolic parameters in PWH who are on modern ART regimens. The investigators examined the impact of EVAF (defined as visceral fat surface area ≥130 cm2 by CT scan) on traditional CVD risk factors and overall cardiovascular (CV) risk in 170 participants with HIV. The prevalence of EVAF in the study was 58%, and the mean visceral fat area was 148 cm2. Among participants with EVAF, values for the Homeostatic Model Assessment for Insulin Resistance (HOMA-IR; p≤0.0001) and triglyceride:high-density lipoprotein (TG:HDL) ratios (p=0.0013) were higher than in those without EVAF. Investigators noted a positive correlation between EVAF and HOMA-IR (ρ=0.43, p≤0.0001) and TG:HDL ratios (ρ=0.33, p≤0.0001). Importantly, greater EVAF was associated with a higher 10-year atherosclerotic cardiovascular disease (ASCVD) risk (p≤0.0001). The investigators also found that increasing visceral fat surface area was inversely associated with growth hormone (GH) levels (ρ=-0.17, p=0.03), and that participants with EVAF had lower GH levels overall (p=0.05). “Excess visceral abdominal fat, or EVAF, is the key characteristic of central adiposity, a condition that is still prevalent in today’s population of people living with HIV, even among those who were never exposed to earlier anti-retroviral agents,” commented VAMOS investigator, John Koethe M.D., Associate Professor of Medicine at Vanderbilt University. “As the quantity of visceral fat rises, 10-year ASCVD risk scores increase, as well as traditional risk factors including insulin resistance and lipid levels. Together, these factors contribute to the heightened risk of cardiovascular disease we see in people with HIV, which is a particular concern among aging individuals. Additionally, the relationship we observed between EVAF and decreased growth hormone levels appears to support a focus on the growth hormone axis to impact EVAF.” Tesamorelin CV Risk Data Researchers examined data from two phase 3 randomized studies to assess the impact of tesamorelin-induced reduction of EVAF on CVD outcomes in 543 PWH. They calculated 10-year ASCVD risk scores for participants at baseline and at 26 weeks of tesamorelin treatment. The percentages of participants on lipid-lowering therapies, antihypertensive treatment, or diabetes medications were 44%, 37%, and 18%, respectively. Although most participants had low CVD risk at baseline, 44% had borderline to high CVD risk. Participants on tesamorelin tended toward a modest reduction in 10-year ASCVD risk scores, with an estimated change of -0.4% (95% confidence interval [CI] -0.89%, 0.05%). The reduction in CVD risk was relatively larger among subjects with higher CVD risk at baseline (p=0.038 for the overall trend among all participants). These reductions in ASCVD risk scores were driven primarily by reductions in total cholesterol, independent of lipid-lowering therapies. “Our analysis provides evidence that tesamorelin may contribute to a reduction in forecasted cardiovascular disease risk in persons with HIV, particularly among individuals at the highest baseline risk,” stated investigator Lindsay Fourman, M.D., Massachusetts General Hospital and Harvard Medical School. “Given the high prevalence of obesity and central adiposity in this population, a strategy that selectively reduces excess visceral abdominal fat may be particularly effective in CVD risk management.” IDWeek 2024, taking place October 16-19, is the joint annual meeting of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, the Pediatric Infectious Diseases Society and the Society of Infectious Diseases Pharmacists. About Theratechnologies Theratechnologies (TSX: TH) (NASDAQ: THTX) is a biopharmaceutical company focused on the development and commercialization of innovative therapies addressing unmet medical needs. Further information about Theratechnologies is available on the Company's website at www.theratech.com, on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov. Follow Theratechnologies on Linkedin and Twitter. Forward-Looking Information This press release contains forward-looking statements and forward-looking information (collectively, the “Forward-Looking Statements”), within the meaning of applicable securities laws, that are based on our management’s beliefs and assumptions and on information currently available to our management. You can identify Forward-Looking Statements by terms such as "may", "will", "should", "could", “promising”, “would”, "outlook", "believe", "plan", "envisage", "anticipate", "expect" and "estimate", or the negatives of these terms, or variations of them. The Forward-Looking Statements contained in this press release include, but are not limited to, statements regarding the use of tesamorelin for visceral abdominal fat reduction contributing to lowering cardiovascular disease risk and attention to targeting excess visceral abdominal fat when considering CVD risk management. Forward-looking statements involve a number of assumptions, risks and uncertainties. Some of these assumptions include, but are not limited to, the fact that people living with HIV taking tesamorelin for visceral abdominal fat reduction will lower the risk of cardiovascular disease. The Company refers current and potential investors to the “Risk Factors” section of the Company’s Annual Information Form filed on Form 20-F dated February 21, 2024 available on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov under Theratechnologies’ public filings for the risks associated with the business of Theratechnologies. The reader is cautioned to consider these and other risks and uncertainties carefully and not to put undue reliance on forward-looking statements. Forward-Looking Statements reflect current expectations regarding future events and speak only as of the date of this press release and represent the Company’s expectations as of that date. The Company undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise, except as may be required by applicable law. Contacts: Media inquiries:Julie SchneidermanSenior Director, Communications & Corporate Affairscommunications@theratech.com1-514-336-7800 Investor Inquiries:Philippe DubucSenior Vice President and Chief Financial Officerpdubuc@theratech.com438-315-6608

AUSTIN, Texas, June 04, 2024 (GLOBE NEWSWIRE) -- Lumos Pharma, Inc. (NASDAQ:LUMO), a clinical-stage biopharmaceutical company focused on therapeutics for rare diseases, announced today details of new analyses of data from its Phase 2 OraGrowtH212 clinical trial presented in two posters at the 2024 Annual Meeting of the Endocrine Society (ENDO), held in Boston, MA, June 1-4, 2024. The posters were presented in parallel sessions on Monday June 3, 2024. “The new analyses of data from our OraGrowtH212 Trial further characterized LUM-201’s unique ability to augment the natural pulsatile secretion of growth hormone, producing comparable growth to injectable rhGH with significantly less exposure to circulating growth hormone,” said John C. McKew, PhD, President and Chief Scientific Officer of Lumos Pharma. “The presented results also provide additional support for our planned approach to a placebo-controlled Phase 3 trial of LUM-201 in moderate PGHD, a trial design proposed by the FDA as an appropriate option for oral LUM-201 given its differentiated mechanism as a growth hormone secretagogue.” In the poster MON-111, titled, Oral LUM-201 Restores Pulsatile Growth Hormone Secretion and Growth Response in Moderate Pediatric Growth Hormone Deficiency (PGHD): Key Discoveries from Phase 2 of OraGrowtH212 Trial (Cassorla, F, et al) [poster link], investigators evaluated growth hormone pulsatility data obtained at baseline and at six months following treatment with LUM-201. Results showed that at six months on LUM-201, a significant increase over baseline in key parameters was observed for the 1.6 mg/kg/day dose. At baseline GH secretion was 0.19 ±0.09 μg/kg/12-hrs; pulsatile GH was 1.17 ±0.66 μg/kg/12-hrs; and total GH was 1.35 ±0.66 μg/kg/12-hrs.At 6 months each parameter increased significantly: GH secretion to 0.36 ±0.21 μg/kg/12-hrs, pulsatile GH to 1.8 ±0.74 μg/kg/12-hrs, and total GH to 2.2 ±0.89 μg/kg/12-hrsA similar level of increase was observed in the 3.2 mg/kg/day dose cohortInvestigators combined data from both dose cohorts and conducted a deconvolution analysis on GH secretion. It was determined that at six months GH secretion was 3.3 ±1.8 to 4.4 ±2.1 μg/kg/day compared to 5.0 ±1.3 μg/kg/day derived from published data in normal children, indicating restoration of approximately normal GH secretion by LUM-201.Conclusion – at 6 months LUM-201 was able to restore endogenous GH pulsatile secretion to a similar level seen in normal children while also normalizing serum IGF-1 concentrations. Results indicate that by restoring endogenous GH secretion, LUM-201 facilitates growth utilizing a much lower amount of GH than that provided by daily exogenous rhGH. By providing an oral therapy that attains physiological GH profiles, investigational LUM-201 treatment aligns with the fundamental objectives of endocrine therapies, specifically the restoration of normal hormonal homeostasis. In a late-breaking poster (MON-704) titled, Growth Response to Oral Growth Hormone Secretagogue LUM-201 in Children with Moderate GH Deficiency (GHD) is Dependent on the Pattern of Pulsatile GH Secretion Stimulated by LUM-201 (Stevens, A, et al), [poster link], investigators evaluated pulsatile GH profiles and growth response to LUM-201. Data from OraGrowtH212 pulse assessments at Day 1 (D1) and at 6 months (M6) were analyzed utilizing a univariate Spearman’s rank correlations matrix to screen for relationships between D1 characteristics, D1 height velocity, 6M Annualized Height Velocity and interpulse, pulsatile, and total GH secretion at D1 and M6.The 12-hour pattern of pulsatile secretion was characterized using Functional Principal Component Analysis (FPCA) to identify dominant modes of variation in the functional data. Subjects were grouped into tertiles based on 6M AHV. The 12-hour profiles were grouped into three 4-hour intervals.Results: All parameters increased from D1 to M6D1 pulsatile GH secretion was positively associated with D1 AHVWhile 6M AHV increased compared to baseline, GH Secretion at D1 and M6 was not apparently correlated with 6M AHVIn the FPCA, difference in interquartile range (IQR) for mean GH secretion was highest in 0-4 hrs in subjects in the high and medium AHV tertiles, while subjects with low AHV at 6 months had the highest difference at 8-12 hours Conclusions – LUM-201 stimulates significant increases in GH secretion over 6 months in patients with moderate PGHD. The relationship between growth response and both the amount and pattern of pulsatile GH secretion, with the highest growth observed in OraGrowtH212 associated with greatest pulsatile activity early in the 12 hour profile. Restoring GH secretion with LUM-201 in moderate PGHD results in both an increase in the overall amount of GH, and importantly, an alteration of the pattern of the pulse profile, with distinct differences in these patterns between the best and lower responders. About Lumos Pharma Lumos Pharma, Inc. is a clinical stage biopharmaceutical company focused on the development and commercialization of therapeutics for rare diseases. The Company was founded and is led by a management team with longstanding experience in rare disease drug development. Lumos Pharma’s lead therapeutic candidate, LUM-201, is a novel, oral growth hormone (GH) secretagogue, seeking to transform the ~$4.7B global GH market from injectable to oral therapy. LUM-201 is currently being evaluated in multiple Phase 2 clinical studies in Pediatric Growth Hormone Deficiency (PGHD) and has received Orphan Drug Designation in both the US and EU. For more information, please visit https://lumos-pharma.com/. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements of Lumos Pharma, Inc. that involve substantial risks and uncertainties. All such statements contained in this press release are forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. A law that, in part, gives us the opportunity to share our outlook for the future without fear of litigation if it turns out our predictions were not correct. We are passionate about our business - including LUM-201 and the potential it may have to help patients in the clinic. This passion feeds our optimism that our efforts will be successful and bring about meaningful change for patients. Please keep in mind that actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that we make. We have attempted to identify forward-looking statements by using words such as “projected,” "upcoming," "will," “would,” "plan," “intend,” "anticipate," "approximate," "expect," “potential,” “imminent,” and similar references to future periods or the negative of these terms. Not all forward-looking statements contain these identifying words. Examples of forward-looking statements include, among others, statements we make regarding the advancement of oral LUM-201 to Phase 3, the potential for LUM-201 to be the first oral therapeutic for PGHD, and any other statements other than statements of historical fact. We wish we were able to predict the future with 100% accuracy, but that just is not possible. Our forward-looking statements are neither historical facts nor assurances of future performance. You should not rely on any of these forward-looking statements and, to help you make your own risk determinations, we have provided an extensive discussion of risks that could cause actual results to differ materially from our forward-looking statements including risks related to the timing and ability of Lumos Pharma to structure our Phase 3 trial in an effective and timely manner, the ability to initiate and advance a pivotal Phase 3 trial, as well as advance our clinical and corporate strategy in general, our ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the ability to successfully develop our product candidate, the effects of pandemics, other widespread health problems or military conflicts including the Ukraine-Russia conflict and the Middle East conflict and other risks that could cause actual results to differ materially from those matters expressed in or implied by such forward-looking statements including information in the "Risk Factors" section and elsewhere in Lumos Pharma’s Quarterly Report on Form 10-Q for the period ended September 30, 2023, as well as other subsequent reports filed with the SEC. All of these documents are available on our website. Before making any decisions concerning our stock, you should read and understand those documents. We anticipate that subsequent events and developments will cause our views to change. We may choose to update these forward-looking statements at some point in the future, however, we disclaim any obligation to do so. As a result, you should not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release. Investor & Media Contact: Lisa MillerLumos Pharma Investor Relations512-792-5454ir@lumos-pharma.com Source: Lumos Pharma, Inc.