LUMO

Lumos Pharma Announces that the USPTO Has Granted Patent Protection for Novel Formulation of LUM-201, Extending Exclusivity to 2042

Retrieved on: 
Wednesday, March 20, 2024
Growth hormone deficiency, LUMO, Patent, United States patent law, Computation, Pharmaceutical industry

This grant of this novel formulation patent extends intellectual property protection through November 2042 for these improved versions of LUM-201 drug product.

Key Points: 
  • This grant of this novel formulation patent extends intellectual property protection through November 2042 for these improved versions of LUM-201 drug product.
  • “We are excited to announce that LUM-201 has been granted a novel formulation patent by the USPTO, which is enabled by unique properties of this molecule achieved through our improved manufacturing processes,” said Rick Hawkins, Lumos Pharma’s Chairman and CEO.
  • “Importantly, this new patent extends our exclusivity of LUM-201 through 2042, surpassing our current method of use patent expiration in 2036.
  • This novel formulation of LUM-201 permits a capsule with mini-tablets, which should reduce dose variance and enable easier administration for younger children.

Lumos Pharma Reports Full Year 2023 Financial Results and Provides Clinical Development Update

Retrieved on: 
Thursday, March 7, 2024
Research, CMO, Transgender hormone therapy, PIN, AHV, Investment, FDA, Endocrinology, LUMO, Webcast, Patient, Clinical trial, Initiation, Travel

AUSTIN, Texas, March 07, 2024 (GLOBE NEWSWIRE) -- Lumos Pharma, Inc. (NASDAQ:LUMO), a late-stage biopharmaceutical company advancing an oral therapeutic candidate for moderate Pediatric Growth Hormone Deficiency (PGHD), today announced financial results for the year ended December 31, 2023 and provided an update on clinical and regulatory activity.

Key Points: 
  • We expect to be in position to initiate this registrational trial in the fourth quarter, pending positive feedback from the FDA.
  • Financial Results for the Year Ended December 31, 2023
    Cash Position – Lumos Pharma ended the year on December 31, 2023, with cash, cash equivalents, and short-term investments totaling $36.1 million compared to $67.4 million on December 31, 2022.
  • Cash on hand as of December 31, 2023, is expected to support operations through the third quarter of 2024.
  • ET today to discuss its financial results and to give an update on clinical programs.

Lumos Pharma to Report Full Year 2023 Financial Results and Host Conference Call on March 7, 2024

Retrieved on: 
Monday, February 26, 2024
LUMO, PIN, Webcast

AUSTIN, Texas, Feb. 26, 2024 (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, announced it will report its full year 2023 financial results after market close on Thursday, March 7, 2024.

Key Points: 
  • AUSTIN, Texas, Feb. 26, 2024 (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, announced it will report its full year 2023 financial results after market close on Thursday, March 7, 2024.
  • The company will host a conference call and webcast at 4:30 PM ET that day to discuss these financial results and provide an update on clinical and corporate activities.
  • Investors and the general public are invited to listen to the conference call.
  • To avoid delays, we encourage participants to dial into the conference call ten minutes ahead of the scheduled start time.

Lumos Pharma to Participate in Oppenheimer’s 34th Annual Healthcare Life Sciences Conference

Retrieved on: 
Monday, February 5, 2024
Conference, LUMO

AUSTIN, Texas, Feb. 05, 2024 (GLOBE NEWSWIRE) -- Lumos Pharma, Inc. (NASDAQ:LUMO), a biopharmaceutical company advancing an oral therapeutic candidate for moderate Pediatric Growth Hormone Deficiency (PGHD), announced today that the Company will participate in the Oppenheimer 34th Annual Healthcare Life Sciences Conference, to be held virtually February 13-14, 2024.

Key Points: 
  • AUSTIN, Texas, Feb. 05, 2024 (GLOBE NEWSWIRE) -- Lumos Pharma, Inc. (NASDAQ:LUMO), a biopharmaceutical company advancing an oral therapeutic candidate for moderate Pediatric Growth Hormone Deficiency (PGHD), announced today that the Company will participate in the Oppenheimer 34th Annual Healthcare Life Sciences Conference, to be held virtually February 13-14, 2024.
  • Lumos Pharma’s management will present and host virtual one-on-one meetings with the investment community on Wednesday, February 14 during the event.
  • Oppenheimer 34th Annual Life Sciences Conference: February 13-14, 2024

Lumos Pharma Promotes Pisit “Duke” Pitukcheewanont, MD to Chief Medical Officer

Retrieved on: 
Thursday, January 4, 2024
Research, CMO, MD, Education, Medical education, University, Human Growth Foundation, Transgender hormone therapy, Helsinki University Central Hospital, Clinical Pediatrics, LUMO, University of Southern California, Publication, Therapy, Senior, Pharmaceutical industry

Duke has extensive experience in clinical development and medical affairs related to the advancement of novel therapeutics for growth disorders.

Key Points: 
  • Duke has extensive experience in clinical development and medical affairs related to the advancement of novel therapeutics for growth disorders.
  • In his role as Lumos Pharma’s CMO, Dr. Duke is expected to significantly bolster the advancement of our clinical programs.”
    “I am honored to assume the role of Chief Medical Officer of Lumos Pharma,” Dr. Pitukcheewanont stated.
  • Dr. Pitukcheewanont initially joined Lumos Pharma in May 2022 as Vice President of Global Clinical Development and Medical Affairs.
  • Before joining Lumos Pharma, Dr. Pitukcheewanont served in key roles as the Vice President of Medical Affairs and Vice President of Global Medical Ambassador and Medical Education at Ascendis Pharma.

Lumos Pharma to Host Virtual Key Opinion Leader Webinar to Discuss Phase 2 OraGrowtH Trial Data and Treatment Potential of Oral LUM-201 for Pediatric Growth Hormone Deficiency

Retrieved on: 
Tuesday, November 21, 2023
Mother, Child, University of Chile, MD, Pediatric endocrinology, Research, University, LUMO, KOL, Pharmaceutical industry

AUSTIN, Texas, Nov. 21, 2023 (GLOBE NEWSWIRE) -- Lumos Pharma, Inc. (NASDAQ:LUMO), a biopharmaceutical company advancing an oral therapeutic candidate for moderate Pediatric Growth Hormone Deficiency (PGHD), announced today that the Company will host a key opinion leader (KOL) webinar to discuss topline results from its Phase 2 OraGrowtH210 and OraGrowtH212 Trials in greater detail.

Key Points: 
  • AUSTIN, Texas, Nov. 21, 2023 (GLOBE NEWSWIRE) -- Lumos Pharma, Inc. (NASDAQ:LUMO), a biopharmaceutical company advancing an oral therapeutic candidate for moderate Pediatric Growth Hormone Deficiency (PGHD), announced today that the Company will host a key opinion leader (KOL) webinar to discuss topline results from its Phase 2 OraGrowtH210 and OraGrowtH212 Trials in greater detail.
  • Management will be joined by three esteemed thought leaders in the field of endocrinology:
    Andrew Dauber, MD, Chief of Endocrinology at Children's National Medical Center, Washington, D.C.
    Fernando Cassorla, MD, Chief of Pediatric Endocrinology at the Institute of Maternal and Child Research, University of Chile
    Virtual KOL Event: Review of Phase 2 OraGrowtH Trial Data and Treatment Potential of Oral LUM-201 for Pediatric Growth Hormone Deficiency Wednesday, December 6, 2023 | 1:30 PM EST
    To register for the virtual KOL Event, please click through the link here .

Lumos Pharma Announces Participation in the Piper Sandler 35th Annual Healthcare Conference in November

Retrieved on: 
Monday, November 20, 2023
Piper Sandler Companies, Conference, Therapy, LUMO

AUSTIN, Texas, Nov. 20, 2023 (GLOBE NEWSWIRE) -- Lumos Pharma, Inc. (NASDAQ:LUMO), a clinical-stage biopharmaceutical company focused on therapeutics for rare diseases, today announced that the Company will participate in the Piper Sandler 35th Annual Healthcare Conference being held November 28th – 30th in New York City.

Key Points: 
  • AUSTIN, Texas, Nov. 20, 2023 (GLOBE NEWSWIRE) -- Lumos Pharma, Inc. (NASDAQ:LUMO), a clinical-stage biopharmaceutical company focused on therapeutics for rare diseases, today announced that the Company will participate in the Piper Sandler 35th Annual Healthcare Conference being held November 28th – 30th in New York City.
  • Lumos Pharma management will present and host one-on-one meetings at the conference.
  • Piper Sandler 35th Annual Healthcare Conference: November 28th – 30th

Lumos Pharma Announces Topline Data from Phase 2 OraGrowtH210 and OraGrowtH212 Trials of LUM-201 in PGHD Met All Primary and Secondary Endpoints

Retrieved on: 
Tuesday, November 7, 2023
Research, ECG, PD, Injection, Injection (medicine), Comparable, Classification, AHV, Child, Transgender hormone therapy, PEM, KOL, University, Safety, Patient, LUMO, Unique, MD, Growth, Standard error, GH, Growth hormone, Coronavirus Scientific Advisory Board, FDA, Șaeș, Aes, Pediatric endocrinology, City of Hope National Medical Center, Mother, LSM, SDS, University of Chile, Political moderate, Silviculture, Vaccine, Pharmaceutical industry, Birth control, Wood drying, Online shopping, Endocrinology

AUSTIN, Texas, Nov. 07, 2023 (GLOBE NEWSWIRE) -- Lumos Pharma, Inc. (NASDAQ:LUMO) today announced that topline results from its Phase 2 OraGrowtH210 dose-finding trial and its Phase 2 OraGrowtH212 Pharmacokinetic/Pharmacodynamic (PK/PD) trial met all primary and secondary endpoints. Data from the OraGrowtH210 Trial demonstrated annualized height velocity (AHV) on the 1.6 mg/kg dose of orally administered LUM-201 of 8.2 cm/yr at six months and 8.0 cm/yr at 12 months on treatment,* in line with historical data in moderate pediatric growth hormone deficiency (PGHD) patients and within the targeted 2 cm/yr margin of the comparator injectable recombinant growth hormone (rhGH) arm. Data also provided preliminary validation of the predictive enrichment marker (PEM) strategy, with prespecified primary and secondary outcomes met, de-risking our patient selection for our Phase 3 program. Data from the OraGrowtH212 Trial confirmed that LUM-201’s unique pulsatile mechanism produces an increase in growth rates while restoring growth hormone secretion and IGF-1 to within normal ranges †, with levels substantially below those produced by exogenous injectable rhGH.†† Additionally, data from a small subset of 10 subjects combined 1.6 and 3.2 mg/kg dosage of LUM-201 in both OraGrowtH210 and OraGrowtH212 trials demonstrated the sustained effectiveness of AHV up to 24 months. Furthermore, the safety profile for LUM-201 remained clean throughout both Phase 2 studies, with no safety concerns identified in either of our Phase 2 trials conducted thus far.

Key Points: 
  • Data also provided preliminary validation of the predictive enrichment marker (PEM) strategy, with prespecified primary and secondary outcomes met, de-risking our patient selection for our Phase 3 program.
  • The OraGrowtH210 trial met its primary objective, with 6-month AHV data of 8.2 cm/yr supporting the 1.6 mg/kg as the optimal dose for a Phase 3 clinical trial.
  • Eighteen and 24-month growth data were available for 10 subjects from the OraGrowtH210 and OraGrowtH212 Trials who met AHV criteria per protocol at 12 months.
  • Every participant in the OraGrowtH212 Trial met the criteria for Patient PEM positivity, ensuring their potential responsiveness to LUM-201.

Lumos Pharma Reports Third Quarter 2023 Financial Results and Clinical Development Updates

Retrieved on: 
Tuesday, November 7, 2023
Research, Transgender hormone therapy, American Association of Clinical Endocrinologists, Event, Child, LUMO, Pediatric endocrinology, Therapy, City of Hope National Medical Center, Rare, IGFBP3, Mother, MD, Quarter, SDS, Endocrine Society, Clinical trial, PEM, KOL, Lumos, University, Serum, University of Chile, Political moderate, European Society of Gynaecological Oncology, Growth hormone, Investment, Consistency, AHV, Silviculture, Pharmaceutical industry, Birth control, Endocrinology

AUSTIN, Texas, Nov. 07, 2023 (GLOBE NEWSWIRE) -- Lumos Pharma, Inc. (NASDAQ:LUMO), a clinical-stage biopharmaceutical company focused on therapeutics for rare diseases, today announced that topline results met primary and secondary endpoints for its Phase 2 Dose-Finding OraGrowtH210 Trial and Phase 2 Pharmacokinetic/Pharmacodynamic (PK/PD) OraGrowtH212 Trial evaluating oral LUM-201 for subjects with moderate pediatric growth hormone deficiency (PGHD) who screened PEM-positive utilizing Lumos Pharma’s predictive enrichment marker (PEM) strategy. Lumos also announced its financial results for the quarter ended September 30, 2023.

Key Points: 
  • Lumos also announced its financial results for the quarter ended September 30, 2023.
  • The Company expects cash use of approximately $9.0 to $10.0 million in the fourth quarter of 2023.
  • Net Loss – The net loss for the quarter ended September 30, 2023 was $8.3 million compared to a net loss of $7.3 million for the same period in 2022.
  • Lumos Pharma ended the third quarter 2023 with 7,914,582 shares outstanding.

Lumos Pharma Announces New Data and Analysis of 15 Subjects from OraGrowtH212 Trial Presented at the 2023 ESPE Annual Meeting

Retrieved on: 
Tuesday, September 26, 2023
IGFBP3, LUMO, Comparable, Time zone, Growth hormone, Serum, IGF, ESPE, Endocrine Society, Doctor of Philosophy, GH, Deconvolution, PEM, 2010 Formula Renault 3.5 Series, MD, Growth, Ageing, Patient, European Society for Paediatric Infectious Diseases, Poster, SD, AHV, Pharmaceutical industry, The Hague

“The presented results add to the growing body of evidence supporting the physiologic mechanism of action for LUM-201, as well as its potential as a treatment for moderate PGHD.

Key Points: 
  • “The presented results add to the growing body of evidence supporting the physiologic mechanism of action for LUM-201, as well as its potential as a treatment for moderate PGHD.
  • The slides presented at ESPE are available on the Posters & Publications page under the Investors & Media section of Lumos Pharma’s website.
  • At baseline, subjects (10M:5F) were (mean ± SD) aged 7.9±1.4 years, with IGF-1 SDS -0.82±0.9, and peak GH 7.2±2.2 ng/mL (clonidine stimulation), consistent with moderate PGHD.
  • Deconvolution analysis was performed on serum GH measured every 10 minutes (0800 h to 2000 h).