Core Insights - Crescent Biopharma has appointed Dr. Jan Pinkas as chief scientific officer, bringing over two decades of experience in oncology drug development [1][2] - The company is advancing its portfolio of next-generation therapeutics for solid tumors, with plans to initiate a global Phase 1 trial for CR-001 in early 2026 and an IND submission for CR-002 in mid-2026 [2][5] Company Overview - Crescent Biopharma aims to build a leading oncology company focused on developing innovative therapies for cancer patients, including a PD-1 x VEGF bispecific antibody and novel antibody-drug conjugates [5] - The company’s pipeline is designed to leverage advancements in cooperative PD-1 x VEGF therapies and next-generation ADCs, targeting both monotherapy and combination treatment opportunities [2][5] Leadership Background - Dr. Pinkas previously served as chief scientific officer at Pyxis Oncology, where he established preclinical research for ADC programs [3] - His experience includes significant roles at Magenta Therapeutics and ImmunoGen, where he contributed to the development of approved therapies such as ELAHERE and SARCLISA [3][4]

Core Insights - Regeneron Pharmaceuticals, Inc. (REGN) received FDA approval for linvoseltamab-gcpt, branded as Lynozyfic, for treating relapsed or refractory multiple myeloma (MM) after at least four prior therapies [1][6][7] - Lynozyfic is a bispecific antibody that connects B-cell maturation antigen (BCMA) on MM cells with CD3-expressing T cells, leading to T-cell activation and cancer cell destruction [2][5] - The approval was based on the LINKER-MM1 trial, which showed a 70% objective response rate and a 45% complete response rate, marking it as one of the most effective bispecific antibodies for this patient group [4][7] Regulatory Approval - Lynozyfic is the first FDA-approved BCMAxCD3 bispecific antibody with a dosing schedule of every two weeks starting at week 14, and every four weeks if a very good partial response is achieved after 24 weeks of therapy [5][7] - The approval addresses a significant unmet need for patients with late-stage MM, who have limited treatment options [6] Market Context - MM is the second most common blood cancer, with over 36,000 new cases expected in the US by 2025 [5] - REGN's shares have declined by 22.9% year-to-date, contrasting with a 0.6% decline in the industry [2] Oncology Portfolio Development - The approval of Lynozyfic enhances REGN's oncology portfolio, which includes Libtayo for various cancers [9] - REGN is also pursuing the approval of odronextamab for treating relapsed or refractory follicular lymphoma and diffuse large B-cell lymphoma, with a target action date for resubmission set for July 30, 2025 [10][11] Competitive Landscape - REGN faces challenges with its lead drug Eylea, which is experiencing declining sales due to competition from Roche's Vabysmo, impacting its market share [11][12]

Core Insights - Exelixis, Inc. (EXEL) shares increased by 7.4% following the announcement of positive results from the late-stage STELLAR-303 study [1][9] - The STELLAR-303 study demonstrated a statistically significant improvement in overall survival for patients treated with zanzalintinib in combination with Tecentriq compared to regorafenib [5][9] - Year-to-date, Exelixis shares have risen by 30.2%, contrasting with a 3.4% decline in the industry [2] Study Details - The STELLAR-303 study is a phase III global, multicenter, randomized, open-label trial involving 901 patients with previously non-MSI-high metastatic colorectal cancer [2][5] - The study's primary endpoints include overall survival in the intent-to-treat population and a subgroup without liver metastases [5][6] - Zanzalintinib is a third-generation oral tyrosine kinase inhibitor targeting receptor tyrosine kinases involved in cancer growth [4] Future Prospects - The trial will continue to analyze the second primary endpoint concerning overall survival in patients without liver metastases [6][9] - The positive results from the STELLAR-303 study enhance the likelihood of regulatory success for zanzalintinib [7] - Exelixis is actively working to diversify its oncology portfolio beyond its lead drug, Cabometyx, with zanzalintinib being developed for various advanced solid tumors [12][14] Collaboration and Market Position - Exelixis is collaborating with Merck to evaluate zanzalintinib in combination with Keytruda for head and neck squamous cell carcinoma [13] - Cabometyx remains a leading tyrosine kinase inhibitor for renal cell carcinoma, with strong demand bolstered by its combination with Opdivo [10][11] - Recent label expansions for Cabometyx are expected to further enhance sales [11]

Core Insights - Regeneron Pharmaceuticals, Inc. announced promising initial results from the early-stage study of oncology drug linvoseltamab, particularly in patients with relapsed/refractory multiple myeloma [1][2] Group 1: Study Results - The LINKER-MM2 trial showed linvoseltamab combined with carfilzomib or bortezomib yielded high response rates in earlier treatment lines for relapsed/refractory multiple myeloma [2] - Efficacy results indicated a 90% objective response rate (ORR) and a 76% complete response (CR) at a median follow-up of 15 months [6] - Among patients treated with linvoseltamab and bortezomib, an 85% ORR was observed with 50% achieving CR [7] Group 2: Patient Demographics - The study included patients who had progressed after at least two lines of therapy, with many being double-class refractory or triple-class exposed [4] - 48% of enrolled patients had baseline soft tissue plasmacytomas, and 39% were over 75 years old, indicating a high-risk patient population [5] Group 3: Regulatory Developments - The European Commission granted conditional marketing approval for linvoseltamab under the brand name Lynozyfic for adults with relapsed/refractory multiple myeloma [8] - The FDA has accepted the resubmission of the Biologics License Application (BLA) for linvoseltamab, with a target action date of July 10, 2025 [9] Group 4: Oncology Portfolio Expansion - Regeneron is focused on strengthening its oncology portfolio, which includes Libtayo for various cancers [10] - The approval of odronextamab for treating relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma has also contributed to the oncology franchise [11] Group 5: Market Competition - The decline in sales of Regeneron's lead drug Eylea is a concern, attributed to competition from Roche's Vabysmo, which has significantly impacted Eylea's market share [12][13]

Core Insights - Kazia Therapeutics Limited has made significant advancements in its clinical programs and corporate strategy, particularly with its lead drug paxalisib, which is being evaluated for multiple cancer types [2][3] Pipeline - Paxalisib - The company received a research grant from The Michael J. Fox Foundation to explore paxalisib's potential as a treatment for Parkinson's disease, funding preclinical studies at The Hebrew University of Jerusalem [4] - A clinical trial has been launched to evaluate the combination of paxalisib with immunotherapy in patients with advanced breast cancer, specifically targeting triple-negative breast cancer [4] - Kazia has aligned with the FDA on the design of a pivotal phase 3 study for paxalisib in glioblastoma, which will enroll approximately 366 patients and compare paxalisib to standard of care [8] Pipeline - EVT801 - The last patient follow-up in a Phase 1 study of EVT801 for advanced solid tumors was completed, with final data expected in Q2 2025 [6] Corporate Developments - Kazia raised $3 million in capital during Q1 2025, including $1 million in non-dilutive funding [2][3] - The company received a notification from Nasdaq regarding its Market Value of Listed Securities falling below $35 million, with a compliance period until November 10, 2025 [9] - Kazia executed a reverse ADS split to maintain compliance with Nasdaq's minimum bid price requirement [9] - The company sold all intellectual property rights to Cantrixil for $1 million, as Vivesto decided not to pursue its development in ovarian cancer [9] - CEO Dr. John Friend purchased 8,000 ADSs at a split-adjusted price of $4.2465 per ADS [9]

Financial Data and Key Metrics Changes - The base business, excluding Veclury, grew by 4% year-over-year, primarily driven by growth in the HIV business [6][50] - Total product sales, including Veclury, decreased by 1% year-over-year, reflecting fewer COVID-19 related hospitalizations [8][50] - Non-GAAP diluted EPS was reported at $1.81 [56] Business Line Data and Key Metrics Changes - HIV sales increased by 6% year-over-year, with Biktarvy sales up by 7% [7][19] - Livedelzi achieved first-quarter sales of $40 million, reflecting early momentum in its launch [27] - Veclury sales were down 45% year-over-year, totaling $302 million [28] - Trodelvy sales decreased by 5% year-over-year, totaling $293 million [29] - Cell therapy sales were down 3% year-over-year, totaling $464 million [31] Market Data and Key Metrics Changes - The HIV treatment market is expected to grow at an annual rate of 23% [22] - Descovy sales increased by 38% year-over-year, driven by higher average realized price and demand [23] - The liver disease segment saw sales of $758 million, up 3% year-over-year [26] Company Strategy and Development Direction - The company plans to launch multiple products, including lenacapavir and anetocel, to drive growth in HIV and oncology [14][34] - Gilead Sciences, Inc. has no major loss of exclusivity (LOE) until the end of 2033, positioning it well for sustained growth [14] - The company is increasing investments in US manufacturing and R&D infrastructure [15][89] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming FDA decision on lenacapavir for PrEP, with a potential launch immediately following [9][38] - The company remains focused on expense management and expects to adapt to macroeconomic changes [56][57] - Management noted that the average corporate tax rate is approximately 20%, reflecting a strong US investment [14] Other Important Information - Gilead Sciences, Inc. received an upgrade in its long-term debt rating from BBB+ to A- [58] - The company has returned $1.7 billion to shareholders in the first quarter of 2025 through dividends and share repurchases [58] Q&A Session Summary Question: Expectations for lenacapavir for PrEP - Management is excited about the upcoming PDUFA date and anticipates building access to about 75% within the first six months post-launch [62] Question: Impact of HHS and CDC cuts on launch - Management has not seen any changes that would affect the launch plans for lenacapavir for PrEP [68] Question: Implications of COVID-19 on Descovy sales - Descovy saw a 38% year-over-year growth, driven by higher average realized price and demand, which supports the opportunity for lenacapavir [77] Question: Tariff risks and US market supply - Management indicated that the majority of Gilead's profits are recognized in the US, which mitigates tariff risks [86] Question: Impact of lenacapavir on Descovy sales - Management believes lenacapavir will provide a switch strategy for patients currently on daily oral medications, potentially accelerating market growth [124]

Group 1 - The oncology drug development landscape is highly competitive, necessitating innovation and clinical validation [1] - Companies that utilize novel platform technologies to develop differentiated therapies are more likely to succeed in this space [1] - Merus focuses on Biclonics and Multiclonics bispecific and multispecific antibodies, positioning itself as a key player in the oncology sector [1] Group 2 - The emphasis on high-growth companies indicates a trend towards sectors that are expected to experience exponential expansion [1] - There is a strong belief in the potential of innovation to generate substantial returns in the investment landscape [1]

Financial Data and Key Metrics Changes - Total revenues for the year ended December 31, 2024, were $28.9 million, an increase of $24.1 million, or 502.1%, compared to $4.8 million for the year ended December 31, 2023 [30] - Net loss for the year ended December 31, 2024, was $9.2 million compared to a net loss of $60.6 million for the year ended December 31, 2023 [34] - Cash, cash equivalents, and short-term bank deposits as of December 31, 2024, were $19.6 million, with approximately $29 million on a pro forma basis after financing completed in early January 2025 [34] Business Line Data and Key Metrics Changes - Revenues in 2024 included $15 million from upfront and milestone payments under the Gloria license agreement and $6 million of net APHEXDA product revenues [31] - Research and development expenses for the year ended December 31, 2024, were $9.2 million, a decrease of $3.3 million, or 26.4%, compared to $12.5 million for the year ended December 31, 2023 [32] - Sales and marketing expenses for the year ended December 31, 2024, were $23.6 million, a decrease of $1.7 million, or 6.7%, compared to $25.3 million for the year ended December 31, 2023 [33] Market Data and Key Metrics Changes - APHEXDA achieved a 10% market share of total CXCR4 inhibitor usage in the U.S. within less than 11 months of being on the market [26] - More than $6 million of net APHEXDA product revenue was generated in the U.S. through the closing of the Ayrmid transaction on November 21 [27] Company Strategy and Development Direction - The company has shifted its strategy to focus on evaluating early clinical stage and late pre-clinical stage therapeutic assets in oncology and rare diseases [6][7] - The exclusive license agreement with Ayrmid Pharma Ltd. for motixafortide allows the company to return to its roots in complex drug development while benefiting from Ayrmid's commercial potential [9][10] - The company aims to help as many patients as possible while creating enduring value for shareholders [20] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about evaluating promising candidates and making definitive announcements within the year [8] - The company has reduced its ongoing operating cash burn by approximately 70%, from over $40 million annually to approximately $12 million annually [18] - The company believes it is well-positioned to advance motixafortide in solid tumor indications while evaluating additional assets in oncology and rare diseases [19] Other Important Information - The Ayrmid agreement generated $10 million in upfront payments and potential milestones of $87 million, along with double-digit sales royalties ranging from 18% to 23% [16] - The company has shut down its U.S. operations and implemented a headcount reduction in Israel, allowing for a streamlined organization [17] Q&A Session Summary Question: Any more color on meaningful progress in evaluating assets? - Management indicated that while there are meaningful discussions ongoing, specific timelines for announcements cannot be provided [38] Question: How are internal programs, especially with WashU and sickle cell, looking? - Management noted that a significant win would be mobilizing enough cells in one cycle for gene therapy, reducing the number of apheresis sessions [43][44] Question: Commentary on increased traction of APHEXDA for multiple myeloma? - Management expressed confidence in Ayrmid's team and their marketing efforts, stating that the transition has gone smoothly [49] Question: How many assets have been looked at in the acquisition process? - Management stated that they have looked at thousands of molecules over the company's history, focusing on early clinical stage assets in oncology and rare diseases [56][58] Question: Allocation of expenses during the acquisition process? - Management confirmed that expenses would initially be higher during the search process, shifting towards R&D as acquisitions are made [59] Question: Internal versus external efforts in the acquisition process? - Management indicated that the majority of the work is done in-house, with external consultants used as needed [64]

Core Viewpoint - Immuneering has appointed Dr. Igor Matushansky as Chief Medical Officer to lead clinical activities and oversee the ongoing Phase 2a study of IMM-1-104 in pancreatic cancer, with plans for a pivotal Phase 3 trial in the future [1][2] Company Overview - Immuneering is a clinical-stage oncology company focused on developing and commercializing therapies that are more effective and better tolerated for cancer patients [3] - The lead product candidate, IMM-1-104, is an oral, once-daily deep cyclic inhibitor of MEK aimed at improving tolerability and expanding indications for RAS-driven tumors, including pancreatic cancer [3] Clinical Development - The ongoing Phase 2a trial of IMM-1-104 is designed to provide first-line pancreatic cancer patients with a new treatment option that is more effective and better tolerated than current standard care [2] - The company plans to present updated data from the Phase 2a trial in Q2 2025 [1] Leadership Experience - Dr. Matushansky brings extensive oncology drug development experience, having previously served as Chief Medical Officer at Sail Biomedicines and held senior roles at Ipsen Pharmaceuticals and Hookipa Pharma [2] - His background includes overseeing the completion of NAPOLI-3, which led to the approval of NALIRIFOX for first-line pancreatic cancer [2]

Table of Contents (Exact name of Registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Australia 2834 Not applicable (Primary Standard Industrial Classification Code Number) As filed with the Securities and Exchange Commission on May 29, 2024 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM F-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 KAZIA THERAPEUTICS LIMITED (I.R.S. Employer Identification No ...