Insulin-Like Growth Factor I Deficiency

Aligns with Eton’s Mission to Develop and Distribute Medicines that Have a Life Changing Impact for Patients with Ultra-rare Conditions Acquisition to Bolster Eton’s Commercial Pediatric Endocrinology Portfolio DEER PARK, IL, USA I October 03, 2024 I Eton Pharmaceuticals, Inc (“Eton” or “the Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced that it has entered into an asset purchase agreement to acquire Increlex® (mecasermin injection) from Ipsen S.A. (“Ipsen”). The acquisition is expected to close near year-end 2024. “Eton’s mission is to develop and distribute medicines that make a life changing impact for patients with the rarest of conditions. Increlex, a critical medication for patients with the ultra-rare condition of severe IGF-1 deficiency, aligns perfectly with our mission and our significant expertise in serving extremely rare patient populations,” said Sean Brynjelsen, CEO of Eton Pharmaceuticals. “Leveraging our strong presence in the pediatric endocrinology community, we aim to raise awareness of this underdiagnosed and undertreated condition. We look forward to collaborating with Ipsen to ensure continuity of care and long-term supply for patients globally.” Increlex is a biologic product used to treat children and adolescents from 2- to 18-years-old who suffer from severe primary insulin-like growth factor 1 deficiency (SPIGFD) because their bodies do not make enough insulin-like growth factor 1 (IGF-1). The medicine is approved in 40 territories, including the United States (U.S.) and the European Union (EU). It is estimated that approximately 200 patients in the United States and 900-1,000 patients in Europe live with SPIGFD. Increlex is the only treatment approved by the U.S. Food and Drug Administration (FDA) or European Medicines Agency (EMA) for SPIGFD. Post closing, Eton will immediately commercialize the product in the U.S. without disruption to patient supply. Outside the U.S., Ipsen will continue distributing the product during a six-month transition period to ensure no disruption to patient supply, after which the commercialization will be continued by Eton. The transaction will be financed by Eton’s cash on hand and an expansion of the Company’s existing credit facility with SWK Holdings. Ipsen reported global sales for Increlex of €17.3 million in 2023. Important Safety Information Contraindications Warnings and Precautions Adverse Reactions Common adverse reactions include hypoglycemia, local and systemic hypersensitivity, and tonsillar hypertrophy. U.S. Indication INCRELEX ® (mecasermin) is indicated for the treatment of growth failure in pediatric patients aged 2 years and older with severe primary IGF-1 deficiency* (IGFD), or with hormone (GH) gene deletion who have developed neutralizing antibodies to GH. Limitations of use: INCRELEX ® is not a substitute to GH for approved GH indications. INCRELEX ® is not indicated for use in patients with secondary forms of IGFD, such as GH deficiency, malnutrition, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory steroids. *Severe primary IGF-1 deficiency (IGFD) is defined by height standard deviation score ≤ -3.0 and basal IGF-1 standard deviation score ≤ -3.0 and normal or elevated GH. Full U.S. Prescribing Information for Increlex ® is available at: http://increlex.com/pdf/hcp-full-prescribing-information.pdf You are encouraged to report negative effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch , or call 1-800-FDA-1088. EU Indication In the European Union, INCRELEX is indicated for the long-term treatment of growth failure in children and adolescents from 2 to 18 years with confirmed severe primary insulin-like growth factor 1 deficiency (Primary IGFD). Severe Primary IGFD is defined by: height standard deviation score <–3.0 and basal IGF-1 levels below the 2.5th percentile for age and gender and GH sufficiency. Exclusion of secondary forms of IGF 1 deficiency, such as malnutrition, hypopituitarism, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory steroids. Severe Primary IGFD includes patients with mutations in the GH receptor (GHR), post-GHR signaling pathway, and IGF 1 gene defects; they are not GH deficient, and therefore, they cannot be expected to respond adequately to exogenous GH treatment. In some cases, when deemed necessary, the physician may decide to assist in the diagnosis by performing an IGF-I generation test. Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu About Eton Eton is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases. The Company currently has five commercial rare disease products: ALKINDI SPRINKLE®, PKU GOLIKE®, Carglumic Acid, Betaine Anhydrous, and Nitisinone. The Company has three additional product candidates in late-stage development: ET-400, ET-600, and ZENEO® hydrocortisone autoinjector. For more information, please visit our website at www.etonpharma.com . SOURCE : Eton

Aligns with Eton's Mission to Develop and Distribute Medicines that Have a Life Changing Impact for Patients with Ultra-rare Conditions Acquisition to Bolster Eton’s Commercial Pediatric Endocrinology Portfolio DEER PARK, Ill., Oct. 03, 2024 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (“Eton” or “the Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced that it has entered into an asset purchase agreement to acquire Increlex® (mecasermin injection) from Ipsen S.A. (“Ipsen”). The acquisition is expected to close near year-end 2024. "Eton's mission is to develop and distribute medicines that make a life changing impact for patients with the rarest of conditions. Increlex, a critical medication for patients with the ultra-rare condition of severe IGF-1 deficiency, aligns perfectly with our mission and our significant expertise in serving extremely rare patient populations," said Sean Brynjelsen, CEO of Eton Pharmaceuticals. "Leveraging our strong presence in the pediatric endocrinology community, we aim to raise awareness of this underdiagnosed and undertreated condition. We look forward to collaborating with Ipsen to ensure continuity of care and long-term supply for patients globally." Increlex is a biologic product used to treat children and adolescents from 2- to 18-years-old who suffer from severe primary insulin-like growth factor 1 deficiency (SPIGFD) because their bodies do not make enough insulin-like growth factor 1 (IGF-1). The medicine is approved in 40 territories, including the United States (U.S.) and the European Union (EU). It is estimated that approximately 200 patients in the United States and 900-1,000 patients in Europe live with SPIGFD. Increlex is the only treatment approved by the U.S. Food and Drug Administration (FDA) or European Medicines Agency (EMA) for SPIGFD. Post closing, Eton will immediately commercialize the product in the U.S. without disruption to patient supply. Outside the U.S., Ipsen will continue distributing the product during a six-month transition period to ensure no disruption to patient supply, after which the commercialization will be continued by Eton. The transaction will be financed by Eton’s cash on hand and an expansion of the Company’s existing credit facility with SWK Holdings. Ipsen reported global sales for Increlex of €17.3 million in 2023. Important Safety Information Contraindications Hypersensitivity to mecasermin (rhIGF-1), any of the inactive ingredients in INCRELEX®, or who have experienced a severe hypersensitivity to INCRELEX®. Allergic reactions have been reported, including anaphylaxis requiring hospitalization.Intravenous Administration.Closed Epiphyses.Benign and malignant Neoplasia in pediatric patients with active or suspected neoplasia or medical history with an increased risk of benign or malignant neoplasia. Warnings and Precautions Hypoglycemia: INCRELEX® should be administered 20 minutes before or after a meal or snack and should not be administered when the meal or snack is omitted. Glucose monitoring and INCRELEX® dose titration are recommended until a well-tolerated dose is established and as medically indicated.Intracranial Hypertension: Funduscopic examination is recommended at the initiation of and periodically during the course of therapy.Lymphoid Tissue Hypertrophy: Patients should have periodic examinations to rule out potential complications.Slipped Capital Femoral Epiphysis: Carefully evaluate any pediatric patient with the onset of a limp or hip/knee pain during INCRELEX® therapy.Progression of Scoliosis: Patients with a history of scoliosis, treated with INCRELEX®, should be monitored.Cardiomegaly: An echocardiogram is recommended before initiation and at termination of mecasermin treatment in all patientsBenign and malignant neoplasms: There have been postmarketing reports of malignant neoplasia in pediatric patients who received treatment with INCRELEX®. The tumors were observed more frequently in patients who received INCRELEX® at higher than recommended doses or at doses that produced serum IGF-1 levels above the normal reference ranges for age and sex. Monitor all patients receiving INCRELEX® carefully for development of neoplasms. If malignant neoplasia develops, discontinue INCRELEX® treatment.Risk of Serious Adverse Reactions in Infants due to Benzyl Alcohol Preserved Solution: Serious and fatal adverse reactions including “gasping syndrome” can occur in neonates and infants treated with benzyl alcohol-preserved drugs. Use of INCRELEX® in infants is not recommended as well as in children below 3 years old. Adverse Reactions Common adverse reactions include hypoglycemia, local and systemic hypersensitivity, and tonsillar hypertrophy. U.S. Indication INCRELEX® (mecasermin) is indicated for the treatment of growth failure in pediatric patients aged 2 years and older with severe primary IGF-1 deficiency* (IGFD), or with hormone (GH) gene deletion who have developed neutralizing antibodies to GH. Limitations of use: INCRELEX® is not a substitute to GH for approved GH indications. INCRELEX® is not indicated for use in patients with secondary forms of IGFD, such as GH deficiency, malnutrition, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory steroids. *Severe primary IGF-1 deficiency (IGFD) is defined by height standard deviation score ≤ -3.0 and basal IGF-1 standard deviation score ≤ -3.0 and normal or elevated GH. Full U.S. Prescribing Information for Increlex® is available at: http://increlex.com/pdf/hcp-full-prescribing-information.pdf You are encouraged to report negative effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. EU Indication In the European Union, INCRELEX is indicated for the long-term treatment of growth failure in children and adolescents from 2 to 18 years with confirmed severe primary insulin-like growth factor 1 deficiency (Primary IGFD). Severe Primary IGFD is defined by: height standard deviation score <–3.0 and basal IGF-1 levels below the 2.5th percentile for age and gender and GH sufficiency. Exclusion of secondary forms of IGF 1 deficiency, such as malnutrition, hypopituitarism, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory steroids. Severe Primary IGFD includes patients with mutations in the GH receptor (GHR), post-GHR signaling pathway, and IGF 1 gene defects; they are not GH deficient, and therefore, they cannot be expected to respond adequately to exogenous GH treatment. In some cases, when deemed necessary, the physician may decide to assist in the diagnosis by performing an IGF-I generation test. Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu About Eton Eton is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases. The Company currently has five commercial rare disease products: ALKINDI SPRINKLE®, PKU GOLIKE®, Carglumic Acid, Betaine Anhydrous, and Nitisinone. The Company has three additional product candidates in late-stage development: ET-400, ET-600, and ZENEO® hydrocortisone autoinjector. For more information, please visit our website at www.etonpharma.com. Forward Looking Statements Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements associated with the expected ability of Eton to undertake certain activities and accomplish certain goals and objectives. These statements include but are not limited to statements regarding Eton’s business strategy, Eton’s plans to develop and commercialize its product candidates, the safety and efficacy of Eton’s product candidates, Eton’s plans and expected timing with respect to regulatory filings and approvals, and the size and growth potential of the markets for Eton’s product candidates. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Eton’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. These and other risks concerning Eton’s development programs and financial position are described in additional detail in Eton’s filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Eton undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Eton Contacts Investors Lisa M. Wilson, In-Site Communications, Inc.T: 212-452-2793E: lwilson@insitecony.com MediaEliza Schleifstein, ES MediaT: 917-763-8106E: eliza@schleifsteinpr.com

Confirms Timing for Primary Outcome Data Readout for two Phase 2 OraGrowtH Trials in Q4 2023 Late Breaking Abstract Accepted for Oral Presentation at ESPE 2023 Encouraging Interim Data from OraGrowtH Trials Presented at ENDO 2023, Highlighted in KOL Webinar Conference Call Scheduled for Today at 4:30pm ET AUSTIN, Texas, Aug. 09, 2023 (GLOBE NEWSWIRE) -- Lumos Pharma, Inc. (NASDAQ:LUMO), a biopharmaceutical company advancing an oral therapeutic candidate for Pediatric Growth Hormone Deficiency (PGHD) through Phase 2 clinical trials, today announced financial results for the second quarter ended June 30, 2023. “We are pleased to confirm our expectation for primary data readout from our two Phase 2 OraGrowtH Trials evaluating LUM-201 in idiopathic PGHD in the fourth quarter of 2023,” said Rick Hawkins, Chairman and CEO of Lumos Pharma. “The primary endpoint for these trials is annualized height velocity at six months on treatment with LUM-201. Given the encouraging data and new analysis presented at ENDO and highlighted in the Key Opinion Leader (KOL) webinar we hosted in June, our convictions are further reinforced that at least one of the LUM-201 dose cohorts will meet growth expectations based on historical averages, and that the LUM-201 mechanism of action and potency can elicit sustained improvements in growth in the moderate PGHD patient population. We look forward to additional analysis of LUM-201 data to be presented at the upcoming ESPE conference in September, and to continuing to advance our LUM-201 clinical program for potentially the first oral therapeutic for PGHD.” Recent Highlights Company reiterates Q4 2023 timing for primary outcome data readout of OraGrowtH210 & OraGrowtH212 Trials Primary endpoint is annualized height velocity (AHV) at 6 months on treatment with the prediction of growth of 8.3 to 8.6 cm/yr based on historical data for this moderate idiopathic PGHD population Other objectives of the OraGrowtH210 Trial are to confirm the utility of the predictive enrichment marker (PEM) strategy and determine the optimal dose for a Phase 3 trial Up to 82 subjects (approximately 20 per cohort) were enrolled in the OraGrowtH210 Trial Up to 22 subjects (approximately 11 per cohort) were enrolled in the OraGrowtH212 Trial AHV data at 12 months on treatment is expected for up to 12 subjects per OraGrowtH210 cohort and up to 7 subjects per OraGrowtH212 cohort, for a total of up to 62 subjects from both trials Additional AHV data at 18 and 24 months on treatment are also expected for a small number of subjects As with all Phase 2 trials in PGHD, OraGrowtH210 is not powered to show non-inferiority of AHV between LUM-201 and the control; these Phase 2 data will support the safety pro the selection of a LUM-201 dose for Phase 3 wherein non-inferiority to a control rhGH arm of < 2 cm should determine success based on historical approvals Data abstract accepted for oral presentation at upcoming European Society of Pediatric Endocrinology (ESPE) annual meeting, September 21-23, 2023, in The Hague, Netherlands Late-breaking abstract—Deconvolution Analysis: GH secretagogue (LUM-201) enhances growth in individuals with moderate idiopathic Pediatric Growth Hormone Deficiency (iPGHD) by enhancing endogenous GH secretion and increasing IGF-1, (Fernando Cassorla, MD)—accepted for oral presentation Saturday, September 23 (9:30-10:30 AM CET) Positive results from Massachusetts General Hospital (MGH) study of injectable growth hormone in NAFLD published in Journal of Clinical Endocrinology and Metabolism – Data support MGH pilot trial evaluating oral LUM-201 in same indication Growth Hormone Administration Improves Nonalcoholic Fatty Liver Disease in Overweight/Obesity: A Randomized Trial—Dichtel, et al. Investigators hypothesized that growth hormone may reduce hepatic steatosis in obese subjects with NAFLD Subjects were randomly assigned to a treatment group (27 GH; 26 placebo), with 41 completers (20 GH and 21 placebo) at 6 months. Reduction in absolute % Intrahepatic Lipid (IHL) content by proton magnetic resonance spectroscopy was significantly greater in the GH vs placebo cohorts Investigators concluded that GH reduces liver fat without commensurate weight loss; data support evaluation of oral LUM-201 in the same indication (NAFLD) The LUM-201 pilot trial in NAFLD continues to enroll; the Company’s primary near-term focus remains on advancing LUM-201 in PGHD New LUM-201 data and analysis presented at ENDO 2023, highlighted in KOL webinar Data from two oral presentations presented at ENDO were highlighted by two distinguished KOLs in a webinar held on June 21, 2023. Details included: New data from the OraGrowtH212 Trial showed an increase in IGF-1 levels on LUM-201 at 6 months that remained within normal range, an increase in IGF-1 SDS to > 0, and a durable growth response after 12 months of LUM-201 administration; clear evidence of potential drug effect for LUM-201 was also observed in consistent improvement in AHV over baseline New analysis of combined OraGrowtH210 and OraGrowtH212 trial data at the 1.6 mg/kg/day and 3.2mg/kg/day dose levels (15 subjects from OraGrowtH212, 20 subjects from OraGrowtH210): results continue to demonstrate that there is a durable response to LUM-201 from 6 to 12 months A replay of the webinar is here and the presented slides are available here Financial Results for the Quarter Ended June 30, 2023 Cash Position – Lumos Pharma ended the quarter on June 30, 2023 with cash, cash equivalents and short-term investments totaling $50.9 million compared to $67.4 million on December 31, 2022. The Company expects an average cash use of approximately $9.5 to $10.5 million per quarter through 2023. Cash on hand as of June 30, 2023 is expected to support operations for at least 12 months following the date of the filing of our second quarter 2023 financial statements. R&D Expenses – Research and development expenses increased by $1.4 million for the three months ended June 30, 2023 compared to the same period in 2022 primarily due to increases of $1.1 million in contract manufacturing expenses, $0.4 million in clinical trial expenses and $0.1 million in personnel-related expenses, offset by a $0.2 million decrease in consulting expenses. G&A Expenses – General and administrative expenses increased by $0.5 million for the three months ended June 30, 2023 compared to the same period in 2022 primarily due to increases of $0.2 million in personnel-related expenses, $0.1 million in stock compensation expenses, $0.1 million in travel expenses and $0.1 million in royalty expenses. Net Loss – The net loss for the quarter ended June 30, 2023 was $8.9 million compared to a net loss of $7.8 million for the same period in 2022. Lumos Pharma ended Q2 2023 with 8,041,345 shares outstanding. Conference Call and Webcast Details The Company has scheduled a conference call and webcast for 4:30 p.m. ET today to discuss its financial results and to give an update on clinical programs. There will also be a question-and-answer session following management’s prepared remarks. Investors and the general public are invited to listen to the conference call. To access the call by phone, please click on this Registration Link, complete the form and you will be provided with dial in details and a PIN. To avoid delays, we encourage participants to dial into the conference call ten minutes ahead of the scheduled start time. The webcast may be accessed through this Webcast Link and may also be found in the “Investors & Media” section of the Lumos Pharma website, under “Events & Presentations.” A replay of the call will be available after the date of the call and may be accessed through the same link above or found on our website. About Lumos Pharma’s Clinical Trials Phase 2 OraGrowtH210 Trial of Oral LUM-201 in PGHD The OraGrowtH210 Trial is a multi-site, global trial evaluating orally administered LUM-201 at three dose levels (0.8, 1.6, 3.2 mg/kg/day) against a standard dose of injectable rhGH in approximately 80 subjects diagnosed with idiopathic (moderate) PGHD, which is less severe than organic PGHD. The objective of this trial is to identify the optimal dose of LUM-201 to be used in a Phase 3 registration trial, based on annualized height velocity from a 6-month dataset, and to prospectively confirm the preliminary validation of our Predictive Enrichment Marker (PEM) strategy. The complete set of 6-month, primary outcome data for 82 subjects is anticipated in the fourth quarter of 2023. Subjects will be dosed for a total of 24 months. OraGrowtH212 Trial Evaluating PK/PD and Pulsatility of Oral LUM-201 in PGHD The OraGrowtH212 Trial is a single site, open-label trial evaluating the pharmacokinetic (PK) and pharmacodynamic (PD) effects of oral LUM-201 in up to 24 PGHD subjects at two dose levels, 1.6 and 3.2 mg/kg/day. The primary objective of the OraGrowtH212 Trial is to confirm prior clinical data demonstrating the amplified pulsatile release of endogenous growth hormone from LUM-201 therapy, contributes to its efficacy in PGHD. The primary endpoint for this trial is 6 months of PK/PD (pulsatility) and height velocity data in the randomized subjects. Subjects will be allowed to remain on treatment until they reach a bone age of 14 for females and 16 for males reflecting near-adult height. Primary data readout in 22 subjects is anticipated in the fourth quarter of 2023. Switch Study, OraGrowtH213 Trial, Evaluating LUM-201 in OraGrowtH210 Subjects Previously on rhGH The OraGrowtH213 Trial is an open-label, multi-center, Phase 2 study evaluating the growth effects and safety of LUM-201 following 12 months of daily rhGH in up to 20 idiopathic PGHD patients who have completed the OraGrowtH210 Trial. Subjects will be administered LUM-201 at a dose level of 3.2 mg/kg/day for up to 12 months. Lumos Pharma Collaboration with Massachusetts General Hospital Evaluating LUM-201 in NAFLD Lumos Pharma has entered a collaboration with Massachusetts General Hospital (MGH) to evaluate LUM-201 in patients with nonalcoholic fatty liver disease (NAFLD). GH is a critical stimulator of lipolysis, and shows anti-inflammatory effects, and preclinical data suggest that amplifying GH secretion has the potential to reduce hepatic steatosis and prevent NAFLD progression. Interestingly, enhancing the natural pulsatile release of GH has been shown clinically in short-term studies to be more efficacious in inducing lipolysis than continuous infusions of GH. This MGH investigator-initiated trial is a single-site, 6-month, open-label pilot study of daily oral LUM-201 in adults with NAFLD. The trial will evaluate a dose of 25 mg/day of LUM-201 in 10 subjects with NAFLD and relative IGF-1 deficiency. The primary endpoints will be to determine the reduction in liver lipid content, inflammation, and fibrosis in these subjects administered LUM-201 compared to each subject’s baseline. 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 $4.5B 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 . 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 therapeutics that are safe, efficacious, and offer a 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, progress in our clinical efforts including the timing of expected results on our LUM-201 trials and our ability to continue advancing our trials, encouraging interim data and new analysis presented, that our convictions are further reinforced that at least one of the LUM-201 dose cohorts will meet growth expectations based on historical averages, that the LUM-201 mechanism of action and potency can elicit sustained improvements in growth in the moderate PGHD patient population, looking forward to additional analysis of LUM-201 data to be presented at the upcoming ESPE conference, continuing to advance our LUM-201 clinical program for potentially the first oral therapeutic for PGHD, that growth hormone may reduce hepatic steatosis in obese subjects with NAFLD, future financial performance, results of operations, our expected average cash use per quarter through 2023 and that cash on hand as of June 30, 2023 is expected to support operations for the next 12 months 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 final results of our LUM-201 Trials being different than our interim results, the outcome of our future interactions with regulatory authorities, the timing and ability of Lumos to raise additional equity capital as needed to fund our Phase 3 Trial or for other purposes, our ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the ability to obtain and maintain the necessary patient enrollment for our product candidate in a timely manner, 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 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 Annual Report on Form 10-K for the year ended December 31, 2022, as well as other 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 Miller Lumos Pharma Investor Relations 512-792-5454 ir@lumos-pharma.com Lumos Pharma, Inc. Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited) (In thousands, except share and per share amounts) Three Months Ended June 30, Six Months Ended June 30, 2023 2022 2023 2022 Revenues: Royalty revenue $ 527 $ 403 $ 1,218 $ 514 Total revenues 527 403 1,218 514 Operating expenses: Research and development 6,024 4,645 10,393 8,866 General and administrative 4,146 3,682 8,503 7,303 Total operating expenses 10,170 8,327 18,896 16,169 Loss from operations (9,643 ) (7,924 ) (17,678 ) (15,655 ) Other income and expense: Other income, net 124 6 243 12 Interest income 559 74 1,129 79 Other income, net 683 80 1,372 91 Net loss before taxes (8,960 ) (7,844 ) (16,306 ) (15,564 ) Income tax benefit 29 — 29 — Net loss $ (8,931 ) $ (7,844 ) $ (16,277 ) $ (15,564 ) Net loss per share: Basic and diluted $ (1.09 ) $ (0.94 ) $ (1.98 ) $ (1.86 ) Weighted average number of common shares outstanding: Basic and diluted 8,164,603 8,366,445 8,205,625 8,361,907 Other comprehensive loss: Unrealized loss on short-term investments (6 ) — (2 ) — Total comprehensive loss $ (8,937 ) $ (7,844 ) $ (16,279 ) $ (15,564 ) Lumos Pharma, Inc. Condensed Consolidated Balance Sheets (In thousands, except share and per share amounts) June 30, December 31, 2023 2022 (unaudited) Assets Current assets: Cash and cash equivalents $ 37,862 $ 56,007 Short-term investments 12,989 11,352 Prepaid expenses and other current assets 4,899 4,427 Other receivables 233 223 Total current assets 55,983 72,009 Non-current assets: Property and equipment, net 45 53 Right-of-use asset 345 230 Total assets $ 56,373 $ 72,292 Liabilities and Stockholders' Equity Current liabilities: Accounts payable $ 279 $ 275 Accrued expenses 6,087 6,200 Current portion of lease liability 179 233 Total current liabilities 6,545 6,708 Long-term liabilities: Royalty obligation payable to Iowa Economic Development Authority 6,000 6,000 Lease liability 167 — Total liabilities 12,712 12,708 Commitments and contingencies: Stockholders' equity: Undesignated preferred stock, $0.01 par value: Authorized shares - 5,000,000 at June 30, 2023 and December 31, 2022; issued and outstanding shares - 0 at June 30, 2023 and December 31, 2022 — — Common stock, $0.01 par value: Authorized shares - 75,000,000 at June 30, 2023 and December 31, 2022; issued 8,061,920 and 8,283,708 at June 30, 2023 and December 31, 2022, respectively and outstanding shares - 8,041,345 and 8,267,968 at June 30, 2023 and December 31, 2022, respectively 80 82 Treasury stock, at cost, 20,575 and 15,740 shares at June 30, 2023 and December 31, 2022, respectively (187 ) (170 ) Additional paid-in capital 187,539 187,164 Accumulated deficit (143,760 ) (127,483 ) Accumulated other comprehensive loss (11 ) (9 ) Total stockholders' equity 43,661 59,584 Total liabilities and stockholders' equity $ 56,373 $ 72,292