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    Kalpit Patel

    Senior Biotech Analyst at B. Riley Securities

    Kalpit Patel is a Senior Biotech Analyst at B. Riley Securities, specializing in emerging companies within the oncology and immunology sectors. He covers a range of biotech firms including Bicycle Therapeutics, Corbus Pharmaceuticals, Foghorn Therapeutics, Geron Corporation, Journey Medical, Kymera Therapeutics, Ovid Therapeutics, Rigel Pharmaceuticals, Syndax Pharmaceuticals, Verastem Oncology, and Viridian Therapeutics, and has delivered an average return of 13.50% per recommendation with a 33% success rate according to recent analyst performance data. Patel began his career as a pharmacist and later transitioned into finance, previously serving as Director at Oppenheimer covering early-stage biotech before joining B. Riley Securities, with over 15 years of healthcare experience. He holds an MBA from the University of Chicago Booth School of Business, a Pharm.D. from the Massachusetts College of Pharmacy, and is a registered pharmacist in Illinois.

    Kalpit Patel's questions to Journey Medical (DERM) leadership

    Kalpit Patel's questions to Journey Medical (DERM) leadership • Q1 2025

    Question

    Inquired about Emrosi's inventory levels in the distribution channel, early real-world feedback from prescribers, the source of new patients (new vs. switches from Oracea), and the concentration of prescribers.

    Answer

    The company estimates typical launch inventory of 2-4 weeks in the channel. Early feedback from the 660 unique prescribers is 'tremendously positive,' driven by strong clinical data and real-world results. The initial launch strategy focuses on new patients, with an expectation that doctors will begin switching existing Oracea patients as they gain comfort and see results. The early onset of efficacy is a key driver for adoption.

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    Kalpit Patel's questions to Journey Medical (DERM) leadership • Q2 2024

    Question

    Kalpit Patel inquired about the potential impact of Oracea's recent generic entry on DFD-29's launch, key performance indicators for investors to track post-launch, and the anticipated SG&A expense ramp for fiscal year 2025.

    Answer

    Claude Maraoui, Co-Founder, President and CEO, stated that the Oracea generic is not considered a critical factor for payer negotiations. He advised investors to monitor total prescriptions, unique prescriber adoption, and market share in the initial quarters. Regarding 2025, he indicated that SG&A would increase to support the launch but noted it was too early to provide specific guidance.

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    Kalpit Patel's questions to Journey Medical (DERM) leadership • Q1 2024

    Question

    Kalpit Patel from B. Riley Securities asked about any preliminary discussions with payers regarding the DFD-29 drug profile and sought confirmation on the company's guidance to achieve cash flow breakeven in fiscal year 2024.

    Answer

    Co-Founder, President and CEO Claude Maraoui stated that recent market research with payers covering over 200 million lives showed an overwhelmingly positive reception for DFD-29, indicating favorable coverage negotiations post-approval. Chief Financial Officer Joseph Benesch reaffirmed that the guidance for achieving full-year positive non-GAAP adjusted EBITDA remains unchanged, noting the core business is already contribution positive when excluding launch costs.

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    Kalpit Patel's questions to Journey Medical (DERM) leadership • Q3 2022

    Question

    Andy, asking on behalf of Kalpit Patel from B. Riley, inquired about the 2023 revenue outlook, specifically whether growth from the four key promoted brands could offset declines from legacy assets prior to the DFD-29 launch. He also requested more detail on the factors driving the sequential decline in the overall Accutane market.

    Answer

    CEO Claude Maraoui stated that the primary impact from Targadox generic competition was absorbed in 2022 and that other legacy brands are expected to remain stable. He affirmed the company's expectation for growth from its four key launched brands in 2023. Regarding Accutane, he attributed the recent market softness to a 12% sequential decline in the broader isotretinoin market, while highlighting that Journey Medical successfully maintained its market share of over 11%.

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    Kalpit Patel's questions to GERON (GERN) leadership

    Kalpit Patel's questions to GERON (GERN) leadership • Q1 2025

    Question

    Kalpit Patel from B. Riley Securities asked for specific inventory levels at the end of Q1 versus Q4, whether new patient starts are outpacing discontinuations, and for an explanation of the Q1 cash burn relative to the net loss.

    Answer

    CFO Michelle Robertson reported that inventory was at the high end of the range at ~3.5 weeks at Q4-end and the low end at ~2.5 weeks at Q1-end. She attributed the higher Q1 cash burn to typical annual bonus payouts and inventory investments. CCO James Ziegler added that while early patients had shorter treatment durations, a promising 25% of new starts are now in earlier lines, which should improve persistence.

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    Kalpit Patel's questions to GERON (GERN) leadership • Q4 2024

    Question

    Kalpit Patel from B. Riley Securities asked for the specific timing of when the revenue flattening began. He also inquired if physicians were targeting specific patient subgroups, such as those with high transfusion burdens, and whether the company still stood by its projection of over $1 billion in peak revenue potential.

    Answer

    Jim Ziegler, CCO, pinpointed the start of the flattening trend to around the Thanksgiving holiday, based on rolling averages. He noted a lack of precise data on subgroup targeting beyond the approved indication. He strongly reaffirmed the company's belief in the blockbuster potential of Rytelo, stating 'Rytelo works' and that the key is to educate a broader physician audience to drive trial and adoption over time.

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    Kalpit Patel's questions to GERON (GERN) leadership • Q3 2024

    Question

    Kalpit Patel of B. Riley Securities questioned the rationale for choosing a complex royalty and debt structure over a simpler equity raise, and asked for any early data on patient adherence and continuation rates.

    Answer

    EVP & CFO Michelle Robertson explained the hybrid financing structure was chosen for flexibility and to reduce dependency on equity markets, thereby avoiding shareholder dilution. EVP & CCO Jim Ziegler stated it is too early for definitive data on continuation rates but noted that anecdotally, they appear consistent with clinical trial results.

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    Kalpit Patel's questions to RIGEL PHARMACEUTICALS (RIGL) leadership

    Kalpit Patel's questions to RIGEL PHARMACEUTICALS (RIGL) leadership • Q1 2025

    Question

    Kalpit Patel inquired about the strategic differences between the TarGeT-D glioma study and the planned company-sponsored Phase 2 trial, and also asked about any other existing ANDA filers for TAVALISSE.

    Answer

    President and CEO Raul Rodriguez and Chief Medical Officer Lisa Rojkjaer clarified the glioma trial strategies. Dr. Rojkjaer explained that the TarGeT-D study evaluates olutasidenib as a maintenance therapy combination in newly diagnosed adolescent and young adult patients, while the upcoming company-sponsored trial will focus on recurrent glioma. Mr. Rodriguez confirmed that the company is not aware of any other ANDA filers for TAVALISSE.

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    Kalpit Patel's questions to RIGEL PHARMACEUTICALS (RIGL) leadership • Q3 2024

    Question

    Kalpit Patel asked about the R289 program in lower-risk MDS, inquiring if Grade 3/4 adverse events were dose-dependent, how much more data would be presented at ASH, and what differentiates R289 from other IRAK inhibitors.

    Answer

    Chief Medical Officer Lisa Rojkjaer stated that details on dose-dependency of adverse events would be shared at the ASH meeting in December. She confirmed the ASH data would include an additional three months of follow-up. President and CEO Raul Rodriguez highlighted that R289's key differentiator is its dual inhibition of both IRAK1 and IRAK4, which is expected to provide more profound inhibition of inflammatory cytokines compared to IRAK4-only inhibitors.

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    Kalpit Patel's questions to Syndax Pharmaceuticals (SNDX) leadership

    Kalpit Patel's questions to Syndax Pharmaceuticals (SNDX) leadership • Q1 2025

    Question

    Kalpit Patel from B. Riley Securities asked for a breakdown of Q1 Revuforj revenue between new patient starts and refills, and for an early estimate of the median duration of therapy.

    Answer

    Chief Commercial Officer Steven Closter responded that it is too early to provide a specific breakdown, as the data is still maturing, but confirmed that both new starts and refills are building strongly, with some patients on their fifth refill. He stated that a definitive median duration of therapy will take a couple more quarters to establish, but early compliance data is encouraging.

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    Kalpit Patel's questions to Syndax Pharmaceuticals (SNDX) leadership • Q3 2024

    Question

    Kalpit Patel of B. Riley Securities asked if there's a minimum efficacy threshold for KMT2A patients to be included on the frontline label and what additional analyses for the pivotal KMT2A cohort might be presented at ASH.

    Answer

    Dr. Neil Gallagher, President and Head of R&D, explained the frontline trial is powered for NPM1, and while they will look for consistency in KMT2A patients, the study is not designed to test a statistical hypothesis for that group. He also indicated that more detailed analyses of the KMT2A data would be presented at ASH but did not specify the details.

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    Kalpit Patel's questions to Kymera Therapeutics (KYMR) leadership

    Kalpit Patel's questions to Kymera Therapeutics (KYMR) leadership • Q3 2024

    Question

    Kalpit Patel from B. Riley Securities inquired about preclinical comparisons of KT-621 to dupilumab in atopic dermatitis models, specifically regarding ear thickness, and asked about the projected human equivalent dose based on mouse model data.

    Answer

    CEO Nello Mainolfi clarified that Kymera focuses on Th2 biomarkers and asthma models over ear thickness, which is a less specific measure. He advised that dose projections should be based on dog and monkey data, not mouse data, due to protein binding differences, suggesting the human dose range will be broadly similar to the IRAK4 program.

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    Kalpit Patel's questions to Kymera Therapeutics (KYMR) leadership • Q1 2024

    Question

    Kalpit Patel asked about the degradation kinetics for the STAT6 program, referencing a previous protein rebound observed with the IRAK4 program, and questioned what steps are being taken to ensure accurate measurement of target knockdown.

    Answer

    President and CEO Nello Mainolfi clarified that the IRAK4 issue was specific to using flow cytometry in a multi-site patient study, where sample handling can introduce variability, unlike the more robust mass spectrometry used in healthy volunteer trials. He assured that for the KT-621 studies, they have planned for multiple opportunities and methods to ensure accurate protein level measurements.

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    Kalpit Patel's questions to LBPH leadership

    Kalpit Patel's questions to LBPH leadership • Q2 2024

    Question

    Asked about the number of different DEEs being targeted in the upcoming study, the expected analysis in the open-label extension data presentation, and the status of the partial clinical hold on LP659.

    Answer

    The company clarified the Phase III study is a broad DEE study that includes LGS, with more details to be shared in September. The upcoming OLE data is from the 6-month cutoff. The partial clinical hold on LP659 is still in place but is expected to be resolved soon with the submission of the MAD study proposal.

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    Kalpit Patel's questions to Forte Biosciences (FBRX) leadership

    Kalpit Patel's questions to Forte Biosciences (FBRX) leadership • Q1 2021

    Question

    Kalpit Patel from B. Riley asked what the company considers a clinically meaningful delta in efficacy for the ongoing study and sought clarification on the scope of the intellectual property for FB-401, specifically if it covers the bacterial species itself.

    Answer

    CEO Paul Wagner explained that based on feedback from thought leaders, a 10 to 15-point difference in the EASI score versus placebo would be clinically significant, given a clean safety profile, which is paramount in pediatrics. Regarding IP, he detailed that the company's 11 issued patents are broad, covering the foundational NIH technique for culturing the bacteria, the composition of matter, methods of use for treating diseases like atopic dermatitis, and kits, providing a very solid IP position.

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