On August 8, 2024 ALX Oncology Holdings Inc., ("ALX Oncology" or "the Company") (Nasdaq: ALXO), an immuno-oncology company developing therapies that block the CD47 immune checkpoint pathway, reported financial results for the second quarter ended June 30, 2024, and provided a corporate update (Press release, ALX Oncology, AUG 8, 2024, View Source [SID1234645583]).

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"Our team continues to make significant progress in the advancement of our evorpacept development pipeline across multiple oncology indications," said Jason Lettmann, Chief Executive Officer of ALX Oncology. "Data readouts across our Phase 1 and 2 clinical trials highlight the potential of evorpacept as a disruptive therapy in combination with anti-cancer antibodies and ADCs. In particular, the recent ASPEN-06 Phase 2 clinical trial readout in patients with previously treated HER2-positive advanced gastric cancer is a significant growth milestone for the Company. We are well positioned to build on our second quarter achievements and continue to advance toward our anticipated milestones in the months ahead."

Second Quarter 2024 Highlights and Recent Developments

Evorpacept Clinical Development Program

On July 31, ALX Oncology reported topline data from the multi-center, international ASPEN-06 Phase 2 clinical trial evaluating evorpacept in combination with trastuzumab, CYRAMZA (ramucirumab) and paclitaxel ("Evo-TRP") against trastuzumab, CYRAMZA (ramucirumab) and paclitaxel ("TRP") for the treatment of patients with HER2-positive gastric/gastroesophageal junction ("GEJ") cancer, where all patients had received an anti-HER2 agent in prior lines of therapy (NCT05002127).
Results demonstrated that evorpacept improved tumor response in patients with HER2-positive gastric/GEJ cancer, becoming the first CD47 blocker to show promising and durable response with a well-tolerated safety profile in a prospective randomized study.
The primary endpoint was confirmed overall response rate ("ORR") with key secondary endpoints being safety, median duration of response ("mDOR"), progression-free survival ("PFS") and overall survival ("OS"). Primary study objectives were to compare confirmed ORR of Evo-TRP to an assumed ORR of 30% for CYRAMZA (ramucirumab) and paclitaxel ("RP") with one-sided alpha error of 0.025, and to identify a clinically meaningful contribution of Evo to TRP in ORR (delta >10%).
Evo-TRP achieved a confirmed ORR of 40.3% compared to 26.6% for the TRP control arm and demonstrated a mDOR of 15.7 months compared to 7.6 months in the intent to treat population ("ITT") (N=127). The primary analysis of the ITT compared Evo-TRP to an assumed RP control ORR of 30% (p=0.095). When a comparison of Evo-TRP to the observed TRP control arm ORR of 26.6% was explored using a similar testing procedure, a p-value of p=0.027 was observed. Secondary endpoints of PFS and OS were immature at the time of analysis.
Evo-TRP combination showed the greatest response with an ORR of 54.8% compared to 23.1% in the TRP control arm in a pre-specified population of patients with fresh HER2-positive biopsies (n=48). In this population, Evo-TRP compared to an assumed RP control ORR of 30% yielded a p-value of p=0.030 . When Evo-TRP compared to the observed TRP ORR of 23.1% was explored using a similar testing procedure, a p-value of p=0.0038 was observed, suggesting HER2-expression strongly correlates with evorpacept efficacy and validating its mechanism of action.
In June, ALX Oncology presented the first evorpacept combination data with an antibody-drug conjugate ("ADC") from the Phase 1 ASPEN-07 clinical trial in patients with advanced urothelial cancer at the 2024 American Society of Cancer Oncology ("ASCO") Annual Meeting.
This open-label, single-arm, clinical trial of evorpacept in combination with an approved ADC, PADCEV (enfortumab vedotin), demonstrated promising activity and was generally well tolerated in patients with locally advanced or metastatic urothelial cancer (NCT05524545).
In April, ALX Oncology reported positive data from the ongoing Phase 1/2 investigator-sponsored clinical trial of evorpacept in combination with standard-of-care in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (NCT05025800).
The combination achieved promising initial activity with a best ORR of 94% and a complete response rate ("CRR") of 83% in patients with indolent R/R B-NHL (compared to rituximab and lenalidomide historical CRR benchmark of 34%).
In April, ALX Oncology announced the initiation of a Phase 2 investigator-sponsored trial of neoadjuvant radiation and evorpacept in combination with KEYTRUDA (pembrolizumab) in patients with previously untreated and early-stage locally advanced, resectable, human papillomavirus-mediated oropharyngeal cancer (NCT05787639).
Conference Presentations

At the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting, ALX Oncology presented the first evorpacept combination data with an ADC from the Phase 1 ASPEN-07 clinical trial in patients with locally advanced or metastatic urothelial cancer.
In the open-label, single-arm, clinical trial of evorpacept in combination with an approved ADC, PADCEV (enfortumab vedotin), demonstrated promising activity and was generally well tolerated in patients.
The Company also presented results of an investigator-sponsored, Phase 2 study of evorpacept, cetuximab and pembrolizumab in patients with refractory microsatellite stable metastatic colorectal cancer.
At the 2024 American Association of Cancer Research Annual Meeting, ALX Oncology presented two evorpacept clinical abstracts including:
Phase 1 investigator-initiated trial of evorpacept, lenalidomide and rituximab for patients with relapsed or refractory B-cell non-Hodgkin lymphoma.
Phase 1 study of azacitidine in combination with evorpacept for higher-risk myelodysplastic syndrome (MDS)
Board and Executive Appointments

ALX Oncology strengthened the Company’s board and leadership team with the appointment of Alan Sandler, M.D., to its Board of Directors, and the addition of Allison Dillon, Ph.D., to its executive leadership team as Chief Business Officer.
Upcoming Clinical Milestones for Evorpacept’s Development Pipeline

ALX Oncology is well-positioned to achieve numerous milestones across multiple oncology indications in its evorpacept clinical development program:
Head and Neck Squamous Cell Carcinoma – Topline results from a Phase 2 randomized clinical trial of ASPEN-03 with KEYTRUDA (1H 2025)
Head and Neck Squamous Cell Carcinoma – Topline results from a Phase 2 randomized clinical trial of ASPEN-04 with KEYTRUDA and chemotherapy (1H 2025)
Gastric/GEJ Cancer – Updated results of ASPEN-06 Phase 2 clinical trial (1H 2025)
Urothelial Cancer – Updated results from a Phase 1 clinical trial of ASPEN-07 in combination with PADCEV (1H 2025)
Gastric/GEJ Cancer – Initiation of Phase 3 registrational randomized clinical trial for evorpacept (mid-2025)
Breast Cancer – Topline results from a Phase 1b I-SPY TRIAL with ENHERTU (fam-trastuzumab deruxtecan-nxki) (2H 2025)
Second Quarter 2024 Financial Results:

Cash, Cash Equivalents and Investments: Cash, cash equivalents and investments as of June 30, 2024, were $186.2 million. The Company believes its cash, cash equivalents and investments, which includes the proceeds from sales under its at-the-market ("ATM") offering in the first half of 2024 are sufficient to fund planned operations well into Q1 2026.
Research and Development ("R&D") Expenses: R&D expenses consist primarily of pre-clinical, clinical and manufacturing expenses related to the development of the Company’s current lead product candidate, evorpacept, and R&D employee-related expenses. These expenses for the three months ended June 30, 2024, were $34.7 million, compared to $29.5 million for the prior-year period. R&D expenses increased by $5.2 million during the three months ended June 30, 2024, compared to the three months ended June 30, 2023. The increase was primarily attributable to an increase of $1.7 million in preclinical costs for development of new targets, an increase of $1.2 million in personnel and related costs primarily driven by headcount growth, an increase of $1.8 million in stock-based compensation expense and an increase of $0.7 million in other research costs primarily due to absence of VAT refunds in the current quarter compared to prior year quarter.
General and Administrative ("G&A") Expenses: G&A expenses consist primarily of administrative employee-related expenses, legal and other professional fees, patent filing and maintenance fees, and insurance. These expenses for the three months ended June 30, 2024, were $6.9 million, compared to $7.3 million for the prior year period. G&A expenses decreased by $0.4 million during the three months ended June 30, 2024, compared to the three months ended June 30, 2023. The decrease was primarily attributable to a decrease of $0.8 million in stock-based compensation expense primarily due to a change in classification from the comparative periods of stock-based compensation from G&A to R&D as described above under R&D expenses, offset by an increase of $0.3 million in other G&A costs from accounting consulting and personnel costs driven by headcount growth.
Net loss: GAAP net loss was $39.4 million for the three months ended June 30, 2024, or ($0.76) per basic and diluted share, as compared to a GAAP net loss of $34.2 million for the three months ended June 30, 2023, or ($0.84) per basic and diluted share. Non-GAAP net loss was $32.1 million for the three months ended June 30, 2024, as compared to a non-GAAP net loss of $27.9 million for the three months ended June 30, 2023. A reconciliation of GAAP to non-GAAP financial results can be found at the end of this news release.

On August 8, 2024 Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, reported financial results for the second quarter ended June 30, 2024, and recent business highlights (Press release, Akebia, AUG 8, 2024, View Source [SID1234645582]). During the quarter, Akebia made significant progress across multiple initiatives related to the commercial launch of Vafseo (vadadustat) Tablets recently approved by the U.S. Food and Drug Administration (FDA) for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months.

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"Since receiving FDA approval in late March, our key priority has been to execute on our launch strategy developed with a goal for Vafseo to become the standard of care in the treatment of anemia for dialysis patients," said John P. Butler, Chief Executive Officer of Akebia. "Our team is actively engaged with prescribers, and I’m extremely encouraged by the positive reception we’ve seen across the kidney community for a new choice in anemia management. Equally important, our commercial team is now in active discussions with dialysis organizations covering the vast majority of patients to contract both Auryxia (ferric citrate) and Vafseo, giving our team a unique opportunity to contract across the portfolio."

Vafseo Global Launch Activities

•In June, Akebia submitted its Transitional Drug Add-on Payment Adjustment (TDAPA) application. Akebia expects to have Healthcare Common Procedure Coding System (HCPCS) codes assigned in October 2024 and TDAPA designation by January 1, 2025.
•Akebia set the Vafseo wholesale acquisition cost (WAC) at $1,278 for a 30-day supply at the labeled starting dose, or approximately $15,500 per year. All Vafseo sales in dialysis will be under contracts that include an off-invoice discount as well as volume-based tier discounts off the WAC price.
•Akebia partner MEDICE Arzneimittel Pütter GmbH&Co.KG (Medice) launched Vafseo in Germany and Austria in June and in the Netherlands in August.
•In July, Akebia regained full rights to sell Vafseo in the U.S. and is now able to contract directly with all dialysis organizations following the execution of a royalty-based termination agreement with CSL Vifor to simplify operational execution and improve economics.

Corporate Updates

In June, Erik Ostrowski joined Akebia as Senior Vice President, Chief Financial Officer and Chief Business Officer. Mr. Ostrowski brings over 20 years of finance and biotech operating experience, with a background in investment banking, including as a director of healthcare investment banking at Leerink Partners. He brings an impressive track record of corporate development leadership and strategic transaction execution.
Akebia reported second quarter 2024 Auryxia net product revenues of $41.2 million. Akebia expects Auryxia full year 2024 net product revenues to be in line with 2023 Auryxia net product revenue levels. Akebia’s commercial organization is heavily engaged in efforts to contract Auryxia through dialysis organizations in 2025, as phosphate binders are expected to be added to the Centers for Medicare & Medicaid Services bundled payment for dialysis care in January 2025.
Financial Results
•Revenues: Total revenues were $43.6 million in the second quarter of 2024 compared to $56.4 million in the second quarter of 2023. The decrease was driven by a reduction in license, collaboration and other revenue, which included a one-time $10 million upfront payment related to our Medice license agreement in the second quarter of 2023.

▪Net product revenues were $41.2 million in the second quarter of 2024 compared to $42.2 million in the second quarter of 2023.

▪License, collaboration and other revenues were $2.4 million in the second quarter of 2024 compared to $14.1 million in the second quarter of 2023.

•Cost of Goods Sold: Cost of goods sold (COGS) was $17.0 million in the second quarter of 2024 compared to $17.3 million in the second quarter of 2023. Akebia continues to carry a non-cash intangible amortization charge of $9.0 million per quarter in COGS through the fourth quarter of 2024.

•Research & Development Expenses: Research and development expenses were $7.6 million in the second quarter of 2024 compared to $20.2 million in the second quarter of 2023. The decrease was largely due to the completion of activities related to certain clinical trials, a reduction in consulting expenses and lower headcount related costs.

•Selling, General & Administrative Expenses: Selling, general and administrative expenses were $26.9 million for the second quarter of 2024 compared to $27.0 million in the second quarter of 2023.

•Net Loss: Net loss was $8.6 million in the second quarter of 2024 compared to $11.2 million in the second quarter of 2023.

•Cash Position: Cash and cash equivalents as of June 30, 2024 were $39.5 million. Akebia expects its existing cash resources and cash from operations will be sufficient to fund its current operating plan, including the U.S. Vafseo launch, for at least two years.
Conference Call
Akebia will host a conference call on Thursday, August 8 at 8:00 a.m. Eastern Time to discuss second quarter 2024 earnings. To access the call, please dial (800) 715-9871 (USA & Canada – Toll-Free) and enter Conference ID: 4155557.

On August 8, 2024 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported clearance by the U.S. Food and Drug Administration (FDA) of the Investigational New Drug (IND) application for ziftomenib, the Company’s potent and selective menin inhibitor, for the treatment of advanced gastrointestinal stromal tumors (GIST) (Press release, Kura Oncology, AUG 8, 2024, View Source [SID1234645559]). The Company plans to initiate a Phase 1 first-in-human study of ziftomenib in combination with imatinib, a targeted therapy approved for the treatment of GIST, in early 2025.

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"This important milestone represents the first IND clearance of a menin inhibitor to treat GIST, a solid tumor indication with limited treatment options for patients with advanced disease," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "Although imatinib is utilized in frontline GIST patients, many eventually develop resistance. Our preclinical data suggest ziftomenib has potential to resensitize patients to imatinib and induce deep, durable responses. We look forward to presenting the preclinical data for the combination at an upcoming scientific meeting and initiating a proof-of-concept clinical study early next year."

GIST is the most common form of sarcoma, characterized as KIT-dependent solid tumors. KIT inhibitors are associated with favorable outcomes for patients with GIST, and imatinib is the standard of care in this patient population. For patients who progress on imatinib, subsequent treatment options include other KIT inhibitors; however, these options are limited by moderate efficacy and challenging tolerability. The menin-MLL complex regulates KIT expression in GIST cells, and menin inhibitors display additive therapeutic activity with imatinib in imatinib-sensitive GIST models1. Preclinical data in imatinib-resistant PDX models suggest that ziftomenib in combination with imatinib has the potential to resensitize patients to imatinib and induce durable responses. Kura plans to initiate a proof-of-concept study evaluating ziftomenib in combination with imatinib in patients with advanced GIST after imatinib failure.

On August 8, 2024 Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, reported an update on the Company’s clinical progress and plans for expansion (Press release, Bio-Path Holdings, AUG 8, 2024, View Source [SID1234645558]).

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"The Bio-Path team continues to work diligently toward advancing our important clinical work and have made meaningful progress in a number of areas critical to each program’s success," said Peter H. Nielsen, President and Chief Executive Officer of Bio-Path. "With the increased clinical data that we have generated, we are now able to develop the biomarkers needed to incorporate into our oncology studies. In addition, we have completed preparations for preclinical work to support advancing prexigebersen as a potential treatment for obesity. In tandem, we are designing development plans for first-in-human clinical studies in this expansive global market for weight loss."

"The incremental advances that we are making across these programs collectively push our DNAbilize platform closer to delivering these medicines to patients. Moreover, we are continuing to see the broader potential of our platform beyond oncology and look forward to realizing its potential across multiple indications, starting with obesity," continued Mr. Nielsen. Clinical Program Overview Bio-Path’s clinical development program consists of one Phase 2 clinical trial and three Phase 1 or 1/1b clinical trials.

Bio-Path has developed a molecular biomarker package to accompany prexigebersen treatment and is currently expanding prexigebersen preclinical studies for the treatment of obesity. Development of Molecular Biomarkers – Bio-Path has developed a molecular biomarker package to accompany prexigebersen treatment, the goal of which is to identify patients with a genetic profile more likely to respond to treatment, thereby improving the probability of success for this program. The emerging role of biomarkers has enhanced cancer development over the past decade and has become a more common companion to many oncology programs.

Prexigebersen Phase 2 Clinical Trial – Bio-Path’s Phase 2 clinical trial is treating Acute Myeloid Leukemia (AML) patients. This trial is comprised of three separate cohorts of patients and treatments, each separately approvable by the FDA as a new drug indication. The first two cohorts are treating patients with the triple combination of prexigebersen, decitabine and venetoclax. The first cohort includes untreated AML patients, and the second cohort includes relapsed/refractory AML patients. Finally, the third cohort is treating relapsed/refractory AML patients, who are venetoclax-resistant or intolerant, with the two-drug combination of prexigebersen and decitabine. Based on recent interim data for safety and efficacy, the Company plans to pursue next development steps by applying molecular biomarkers to future patient selection for enrollment into the Phase 2 clinical trial. Outcomes for these older patients who are unable to receive intensive chemotherapy due to the challenging side effect profile remain suboptimal with a median survival of only five to ten months. The study is currently paused for an interim analysis, amendment preparation and U.S. Food and Drug Administration (FDA) review. Bio-Path expects to complete enrollment in cohorts 1 and 2 of the study over the next eighteen months. Phase 1/1b Clinical Trial in BP1001-A in

Advanced Solid Tumors – A Phase 1/1b clinical trial of BP1001-A in patients with advanced or recurrent solid tumors, including ovarian and uterine, pancreatic and breast cancer, is ongoing. BP1001-A is a modified product candidate that incorporates the same drug substance as prexigebersen but has a slightly modified formulation designed to enhance nanoparticle properties. The Phase 1 study has advanced to the second, higher dose level. The Phase 1b portion of the study is expected to commence after successful completion of the three

BP1001-A monotherapy dose level cohorts and is intended to assess the safety and efficacy of BP1001-A in combination with paclitaxel in patients with recurrent ovarian or endometrial tumors. Phase 1b studies are also expected to be opened in combination with gemcitabine in late stage pancreatic cancer. In recent months, Bio-Path advanced to dose level 2 and expects to complete enrollment in order to advance to dose level 3 by year-end.

Phase 1/1b Clinical Trial in BP1002 in Relapsed/Refractory AML – A Phase 1/1b clinical trial for BP1002 to treat relapsed/refractory AML patients, including venetoclax-resistant patients, is ongoing. BP1002 targets the protein Bcl-2, which is responsible for driving cell survival in up to 60% of all cancers. The drug venetoclax treats AML patients by blocking the activity of the Bcl-2 protein in AML patients. However, patients become resistant to venetoclax. BP1002 treats the Bcl2 target by blocking the cell’s ability to produce Bcl-2, and could have the potential to eliminate the need for venetoclax.

AML patients that fail frontline venetoclax-based therapy have very poor prognosis with median overall survival of less than three months. The first dose cohort consisted of a starting dose of 20 mg/m2, and there were no dose limiting toxicities. Bio-Path recently completed the second dose cohort of 40 mg/m2 and is completing an analysis of PK/PD data to be submitted to the FDA in order to advance to the next dose level. Upon submission of data and approval from FDA, Bio-Path expects to advance to dose level 3 in the fourth quarter of 2024.

Phase 1 Clinical Trial in BP1002 in Refractory/Relapsed Lymphoma and Chronic Lymphocytic Leukemia (CLL) – A Phase 1 clinical trial to evaluate the ability of BP1002 to treat refractory/relapsed lymphoma and refractory/relapsed chronic lymphocytic leukemia (CLL) patients is currently ongoing. The Phase 1 clinical trial is being conducted at the Georgia Cancer Center, The University of Texas Southwestern and New York Medical College. In January 2024, Bio-Path announced successful completion of the first dose cohort in the Phase 1 clinical trial. A total of six evaluable patients are scheduled to be treated over two dose levels with BP1002 monotherapy in a standard 3+3 design, unless there is a dose limiting toxicity which would require an additional three patients to be tested. There were no dose limiting toxicities in the first dose cohort (20 mg/m2). Enrollment has continued for patients in the second BP1002 dose cohort of 40 mg/m2 and the Company expects to complete enrollment and to review these data by year-end.

Preclinical Work for BP1003 – The Company continues to advance its drug candidate, BP1003, for the treatment of advanced solid tumors, including pancreatic cancer. BP1003 is an antisense RNAi nanoparticle targeting the STAT3 protein. Plans are to conduct a Phase 1 study of BP1003 in patients with refractory, metastatic solid tumors (pancreatic, non-small cell lung cancer). Prexigebersen as Potential Treatment for Obesity and Obesity-related Cancers – The RNAi target of prexigebersen is the Grb2 protein, which is involved in activating the RAS/ERK pathway for cell growth. By blocking the cell’s ability to produce Grb2, prexigebersen treatment may limit cell growth. In obesity, two such pathways are related to leptin and insulin. Activation of leptin or insulin receptors can stimulate the RAS/ERK pathway via Grb2i.

Bio-Path believes development of prexigebersen for the treatment for obesity and obesity-related cancers could be accelerated given the large amount of safety data from prexigebersen treatment of leukemia patients and the continued unmet medical need. The Company is preparing for preclinical development evaluating prexigebersen for the treatment of obesity and will continue thereafter to conduct additional Investigational New Drug (IND)-enabling studies with an aim to advance prexigebersen into first-in-human studies in this indication.

On August 7, 2024, Precigen, Inc. ("Precigen") reported to have entered into an underwriting agreement (the "Underwriting Agreement") with Stifel, Nicolaus & Company, Incorporated, as the representative of the several underwriters named therein (the "Underwriters"), in connection with the underwritten public offering (the "Offering") of 35,294,118 shares (the "Firm Shares") of Precigen common stock, no par value ("Common Stock"), at a price to the public of $0.85 per share (Filing, 8-K, Precigen, AUG 7, 2024, View Source [SID1234645682]). Pursuant to the Underwriting Agreement, Precigen granted to the Underwriters the option to purchase up to an additional 5,294,117 shares of Common Stock (together with the Firm Shares, the "Shares") for a period of 30 days from the date of the Underwriting Agreement.

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Net proceeds to Precigen from the offering will be approximately $31.4 million after deducting the underwriting discount and other estimated offering expenses payable by Precigen, such proceeds including the sale of 4,584,821 shares of Common Stock exercised pursuant to the Underwriters’ option to purchase additional shares.

The Offering was made pursuant to Precigen’s shelf registration statement declared effective on January 17, 2024 (Registration No. 333-276337), as supplemented by the final prospectus supplement dated August 7, 2024.

The Underwriting Agreement includes certain customary representations, warranties, and covenants by Precigen, and it provides that Precigen will indemnify the Underwriters against certain liabilities, including liabilities under the Securities Act of 1933, as amended, or contribute to payments the Underwriters may be required to make because of any of those liabilities. The representations, warranties, and covenants contained in the Underwriting Agreement were made only for purposes of such agreement and as of specific dates, were solely for the benefit of the parties to such agreement, and may be subject to limitations agreed upon by the contracting parties. The foregoing description of the Underwriting Agreement does not purport to be complete and is qualified in its entirety by reference to the Underwriting Agreement, which is filed as Exhibit 1.1 hereto and incorporated herein by reference.