On May 15, 2023 bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company addressing the need for noninvasive detection of early-stage lung cancer and other diseases of the lung, reported financial results for the three months ended March 31, 2023 (Press release, BioAffinity Technologies, MAY 15, 2023, View Source [SID1234631703]).

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Highlights from the first quarter of 2023 and subsequent weeks included:

Corporate and Commercial Highlights

● Appointed Michael Dougherty as Chief Financial Officer. Mr. Dougherty most recently served as CFO of Amazon’s Alexa commercial domains, where he was responsible for financial strategy over Alexa’s multibillion-dollar investments in AI-generated customer experiences.
● Engaged Havas Health & You and Trinity Life Sciences to create the branding and marketing strategy for CyPath Lung.
● Continued with the initial rollout of CyPath Lung to select test markets in Texas with encouraging user feedback and survey responses.
● Management rang the Nasdaq Stock Market closing bell on April 5 to commemorate the Company’s IPO in September 2022.

Research and Development Highlights

● Received Notice of Allowance from the U.S. Patent and Trademark Office for a patent titled "Porphyrin Compounds and Compositions Useful for Treating Cancer" for the targeted delivery of novel cancer treatments. This patent is owned by the Company’s wholly owned subsidiary OncoSelect Therapeutics and grants protection through 2037.
● Expanded geographic coverage for this OncoSelect Therapeutics patent to include issuance in Hong Kong, which joins the U.S., Australia, China and Mexico, with patent applications pending in Canada, the European Union, India and Japan.
● CyPath Lung clinical validation study results were published in Respiratory Research and demonstrated 92% sensitivity and 87% specificity in high-risk patients with nodules smaller than 20 millimeters or no nodules in the lung, with an area under the ROC curve of 94%.

● The article "Porphyrin-Modified Beads for Use as Compensation Controls in Flow Cytometry" was published in the peer-reviewed Journal of Visualized Experiments (JoVE) and describes the protocol for preparing porphyrin-labeled compensation beads to optimize the ability of CyPath Lung to detect early-stage lung cancer.
● Presented advancements in CyPath Lung at the Cleveland Clinic’s invitation-only fourth annual "Advances in Early Lung Cancer Detection" Symposium, which brings together global leaders in the field of lung cancer, including physicians, advocates and industry, to accelerate the development and implementation of new technologies and methods for early lung cancer detection.

Management Commentary

"Our first quarter results reflect our focus on positioning bioAffinity Technologies both financially and organizationally to achieve our most important near-term objective: expanding the commercial launch of CyPath Lung into additional markets to optimize our rollout for maximum success. Preliminary commercial results are encouraging, and with constructive initial feedback from physicians, we’re fine-tuning the CyPath Lung branding and marketing strategy. A survey of pulmonologists, internists and primary care physicians shows that they understand the need for a noninvasive, accurate lung cancer diagnostic and are receptive to including the test as part of their clinical decision-making for high-risk patients," bioAffinity President and Chief Executive Officer Maria Zannes said.

"CyPath Lung is currently commercially available as a laboratory developed test through our licensee, Precision Pathology Services. The launch of our pivotal clinical trial later this year is a critical step toward securing FDA clearance as a Class II in vitro diagnostic, which would enable us to market directly to U.S. physicians and their patients and facilitate dialogues with payers," Ms. Zannes added.

First Quarter Financial Results

Revenue for the first quarter of 2023 was $1,000, compared with no revenue for the prior-year period. Revenue is currently generated exclusively from royalties from the Company’s licensee, Precision Pathology Services, from sales of CyPath Lung as a laboratory developed test.

Research and development expenses were $370,000 for the first quarter of 2023, compared with $280,000 for the comparable period in 2022. The increase was primarily due to higher compensation costs from adding research personnel and higher R&D equipment costs.

Clinical development expenses were $20,000 for the first quarter of 2023, compared with $53,000 for the first quarter of 2022. The decline was primarily attributed to lower professional fees related to clinical strategy evaluation as the Company prepares to launch the CyPath Lung pivotal trial.

Selling, general and administrative expenses were $1.2 million for the first quarter of 2023, compared with $395,000 for the comparable period in 2022. The increase was primarily attributed to higher consulting, legal and professional fees incurred to comply with public company reporting requirements.

Net loss for the first quarter of 2023 was $1.5 million, or $0.18 per share, compared with a net loss of $1.5 million, or $0.55 per share, for the comparable period in 2022.

Cash and cash equivalents as of March 31, 2023, were $9.8 million, compared with $11.4 million as of December 31, 2022. bioAffinity Technologies believes that its available cash will be sufficient to fund planned operations for at least the next 12 months.

On May 15, 2023, Arcus Biosciences, Inc. ("Arcus") reported to have entered into an amendment ("Amendment No. 2") to its Option, License and Collaboration Agreement with Gilead Sciences, Inc. ("Gilead") dated May 27, 2020 (Filing, Arcus Biosciences, MAY 15, 2023, View Source [SID1234631701]). Pursuant to Amendment No. 2, Arcus will receive an upfront payment of $35 million and will initiate research programs against up to four targets jointly selected by the parties that are applicable to inflammatory diseases. Gilead may exercise an option to license each program at two separate, prespecified time points. If Gilead exercises its option at the earlier time point for the first two target programs, Arcus would be eligible to receive up to $420 million in option and milestone payments and tiered royalties for each optioned program. For any other option exercise by Gilead for the four target programs, the parties would have rights to co-develop and share global development costs and to co-commercialize and share profits in the United States for optioned programs.

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The foregoing is only a brief description of Amendment No. 2 and does not purport to be a complete description of its terms and is qualified in its entirety by reference to the amendment, which will be filed as an exhibit to Arcus’s Quarterly Report on Form 10-Q for the quarter ending June 30, 2023.

On May 15, 2023 Aprea Therapeutics, Inc. (Nasdaq: APRE) ("Aprea", or the "Company"), a clinical stage biopharmaceutical company focused on developing novel synthetic lethality-based cancer therapeutics targeting DNA damage response (DDR) pathways, reported financial results for the three months ended March 31, 2023 and provided a business update (Press release, Aprea, MAY 15, 2023, View Source [SID1234631700]).

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"We are excited about the strong start for 2023 as we focus on the execution of the pipeline development plan and continue enrollment in our Phase 1/2a dose escalation study of our ATR inhibitor, ATRN-119, in patients with biomarkers related to DDR mutations," said Oren Gilad, Ph.D., President and Chief Executive Officer of Aprea. "Our cash position remains strong with a runway to carry us into the third quarter of 2024 and cross meaningful clinical milestones in our two lead inhibitor programs, ATR and WEE1. In February, we closed an underwritten public offering pursuant to which the Company received approximately $4.9 million in net proceeds. In April, we participated in the American Association of Cancer Research Conference where we had the opportunity to share preclinical results pointing to the potential, groundbreaking benefits of combination therapy with ATRN-119 and ATRN-1051. Our IND-enabling studies continue to progress for our ATRN-1051 inhibitor program and anticipate filing an IND by the end of 2023."

Key Business and Financial Updates

ATR inhibitor program: ATRN-119 – Enrollment continues in the Phase 1/2a trial of Aprea’s lead clinical candidate, ATRN-119, a potential best-in-class ATR inhibitor for treatment of advanced solid tumors harboring defined mutations in DDR pathways. ATRN-119 is an orally bioavailable, potent and selective macrocyclic small molecule inhibitor of ATR. ATR is one of several key regulators impacting response to defective DNA replication and DNA damage, which occurs more commonly in cancer cells than in normal cells. Primary endpoints of the Phase 1 dose escalation part of the study include safety, tolerability, pharmacokinetics and a recommended Phase 2 dose. The Company expects to report initial safety, tolerability, and pharmacokinetic data from the ongoing Phase 1 trial of ATRN-119 in the first quarter of 2024.

WEE1 inhibitor program: ATRN-1051 – ATRN-1051 is an orally-bioavailable, highly potent and selective small molecule inhibitor of WEE1, a key regulator of multiple phases of the cell cycle. The Company believes preclinical findings support potentially favorable drug selectivity and exposure. Investigational New Drug (IND) enabling studies with ATRN-1051 are under way, and the Company anticipates filing an IND by the end of 2023.

Presented Preclinical data on pipeline programs at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2023 Annual Meeting, held April 14-19, 2023, in Orlando, Florida. In April 2023, the Company presented a poster, titled "ATRN-119 and ATRN-W1051: Novel and potentially well tolerated ATR and WEE1 inhibitors for targeted cancer treatment," highlighting its lead program, ATRN-119, and preclinical WEE1 inhibitor, ATRN-1051. In in vivo models, ATRN-119 demonstrated anti-tumor efficacy, both as a monotherapy and in combination with PARP inhibitors. In xenograft models, ATRN-1051 demonstrated high potency, potentially favorable pharmacokinetic properties, and anti-tumor efficacy.

Secured non-dilutive funding via a research grant from the National Cancer Institute (NCI) supporting development of DDR inhibitors. In February 2023, the Company announced that it received an award notification from the NCI for the development of a first-in-class combination of DNA damage response inhibitors for the treatment of high-grade serous ovarian cancer (HGSOC). HGSOC is a devastating disease responsible for the deaths of about 125,000 women worldwide each year and has low survival rates.

Closed an underwritten public offering in February 2023 pursuant to which the Company received approximately $4.9 million in net proceeds, after deducting underwriting discounts and offering expenses. Net proceeds from the public offering support the continuing development of ATRN-119 and ATRN-1051 as well as general corporate overhead.
Appointed Gabriela Gruia, M.D., to the Board of Directors, strengthening the Company’s leadership. Dr. Gruia brings over 25 years of clinical, regulatory and life science leadership experience to Aprea, having worked for Novartis, Pfizer, Pharmacia, Aventis and Rhone Poulenc. Dr. Gruia received her M.D. from Bucharest Medical School in Romania and a Masters in Breast Pathology and Mammography from Rene Huguenin/Curie Institute Cancer Center in Paris, France.
Select Financial Results for the First Quarter ended March 31, 2023

As of March 31, 2023, the Company reported cash and cash equivalents of $31.0 million.
For the quarter ended March 31, 2023, the Company reported an operating loss of $4.6 million, compared to an operating loss of $8.1 million for the same period in 2022.
Research and Development (R&D) expenses were $1.3 million for the quarter ended March 31, 2023, compared to $4.1 million for the same period in 2022. The decrease in R&D expense was related to lower clinical trial expense primarily due to the close out of legacy Aprea clinical trials, lower personnel costs for the former facility in Sweden, and lower non-cash stock-based compensation expense.
General and Administrative (G&A) expenses were $3.4 million for the quarter ended March 31, 2023, compared to $4.0 million for the same period in 2022. The decrease in G&A expenses was due to a lower non-cash stock-based compensation and insurance premium expenses, partially offset by higher personnel costs in the quarter ended March 31, 2023 related to severance expenses for former executives.
The Company reported a net loss of $4.4 million ($1.34 per basic share) on approximately 3.3 million weighted-average common shares outstanding for the quarter ended March 31, 2023, compared to a net loss of $7.9 million ($7.25 per basic share) on approximately 1.1 million weighted average common shares outstanding for the same period in 2022.

On May 15. 2023 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company"), an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders and viral diseases – including COVID-19, the disease caused by the SARS-CoV-2 virus – reported its financial results for the first quarter 2023 and provided a business update (Press release, AIM ImmunoTech, 15 15, 2023, View Source [SID1234631698]). As previously announced, the Company will host a conference call and audio webcast on Tuesday, May 16, 2023, at 8:30 AM ET (details below).

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"The significant progress we have made advancing Ampligen through numerous human clinical studies in multiple indications has provided us with a growing body of positive data. These data have supported and guided the prioritization of our oncology pipeline, with pancreatic cancer as our lead development program," commented Thomas K. Equels, Chief Executive Officer of AIM. "With a strong cash position and a fundamental plan to execute across our pipeline, we are positioning the Company to achieve a number of value-driving milestones in the near term."

Recent Highlights

Appointed preeminent biotechnology pioneer W. Neal Burnette, Ph.D., as Chairman of its Scientific Advisory Board (SAB)
Nancy K. Bryan, pharmaceutical industry veteran, appointed to Board of Directors
Received central Institutional Review Board ("IRB") approval for the protocol of Phase 2 study evaluating Ampligen as a therapeutic for patients with post-COVID conditions ("AMP-518")
Expected Upcoming Pipeline Milestones

Q2 2023

Locally Advanced Pancreatic Cancer: Enroll first patient in Phase 2 study
Post-COVID Conditions: Enroll and dose first patient in Phase 2 study
Q3 2023

Advanced Recurrent Ovarian Cancer: Announce protocol-planned interim results
Q4 2023

Metastatic Pancreatic Cancer: Begin clinical trial
Post-COVID Conditions: Enroll last patient in Phase 2 study
Summary of Financial Highlights for First Quarter 2023

As of March 31, 2023, AIM reported cash, cash equivalents and marketable securities of $30.8 million. Based on management’s current expectation, the Company’s cash runway is expected to fund operations through multiple key milestones through the end of 2024.
Research and development expenses for the three months ended March 31, 2023 were $2.1 million, compared to $1.0 million for the same period in 2022.
General and administrative expenses were $2.3 million for the three months ended March 31, 2023, compared to the $2.1 million for the same period 2022.
The net loss from operations for the three months March 31, 2023 was $3.7 million, or $0.08 per share, compared to $3.8 million, or $0.08 per share, for the three months ended March 31, 2022.
Please refer to the full 10-Q for complete details.

Conference Call and Webcast Details

As previously announced, the Company will host a quarterly conference call and live audio webcast to discuss the operational and financial results on May 16, 2023, at 8:30 AM ET.

The call will be hosted by members of AIM, CEO Thomas K. Equels and Scientific Officer Christopher McAleer, PhD. Interested participants and investors may access the conference call by dialing (877) 407-9219 (domestic) or (201) 689-8852 (international) and referencing the AIM ImmunoTech Conference Call. The live webcast will be accessible on the Events page of the Investors section of the Company’s website, aimimmuno.com, and will be archived for 90 days following the live event.

On May 15, 2023 Adamis Pharmaceuticals Corporation (NASDAQ: ADMP), a commercial-stage biopharmaceutical company focused on developing and commercializing products in various therapeutic areas, including opioid overdose, allergy, respiratory and inflammatory disease, reported financial results for the first quarter ended March 31, 2023, and provided an update on recent corporate developments (Press release, Adamis Pharmaceuticals, MAY 15, 2023, View Source [SID1234631697]).

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Q1 2023 Corporate Highlights

Nasdaq Continued Listing

· On February 23, 2023, Adamis announced that Nasdaq had granted its request to extend the period for the Company to regain compliance with the $1 minimum bid share price requirement, subject to the Company evidencing compliance with all applicable criteria for continued listing, by no later than a final extension date of June 26, 2023.

· The Company’s continued listing is subject to the timely satisfaction of certain interim milestones and undertaking of certain corporate actions during the compliance period, including without limitation: (1) the Company executing the merger agreement with DMK Pharmaceuticals Corporation; (2) effecting a reverse stock split of its common stock; and (3) achieving the minimum closing bid price of at least $1.00 per share for a minimum of ten consecutive business days prior to the expiration of the compliance period.

· On April 12, 2023, Adamis received another notice from Nasdaq indicating that for the last 30 consecutive business days, the Company’s minimum Market Value of Listed Securities (MVLS) was below the minimum of $35 million required for continued listing on the Nasdaq Capital Market. Pursuant to Nasdaq listing rules, the Company will have until October 9, 2023, to regain compliance with the MVLS standard, which requires that the MVLS be at least $35 million for a minimum of 10 consecutive business days at any time before expiration of the compliance period. The notice had no current effect on the listing of the Company’s common stock.

· The Company believes that by both effecting a reverse stock split and closing the merger transaction with DMK Pharmaceuticals, it can regain compliance with both Nasdaq requirements prior to the June 26th deadline.

Merger Agreement with DMK Pharmaceuticals

· On February 24, 2023, the Company entered into an Agreement and Plan of Merger and Reorganization with DMK Pharmaceuticals Corporation (the "Agreement").

· DMK is a private, clinical-stage biotechnology company at the forefront of endorphin-inspired drug design focused on developing novel treatments for opioid use disorder and other neuro-based diseases.

· At a special meeting of stockholders of the Company held on May 15, 2023, the stockholders of the Company approved proposals relating to the proposed DMK merger transaction and the proposed reverse stock split. The Company expects to close the merger transaction as soon as all remaining closing conditions have been either met or waived by the parties.

Financing

· On March 14, 2023, the Company announced that it had entered into a securities purchase agreement with a single, healthcare-focused institutional investor for the purchase and sale of 16,500,000 shares of its common stock and pre-funded warrants to purchase up to 7,500,000 shares of common stock, together with warrants to purchase up to 48,000,000 shares of common stock. The Company received gross proceeds of approximately $3.0 million, before deducting fees and other estimated offering expenses.

· On May 2, 2023, the investor exercised the pre-funded warrants in full.

Q1 2023 Financial Highlights

· Total net revenue for the first quarter of 2023 was approximately $1.5 million compared to approximately $1.2 million in the first quarter of 2022, an increase of approximately 26%. The increase in revenues was primarily due to increased sales of ZIMHI. No revenues relating to SYMJEPI were reported in the first quarter of 2023 or 2022, due to its manufacturing hold and voluntary recall that was announced in March 2022.

· Operating expenses (selling, general and administrative expenses and research and development expenses) for the first quarter of 2023 were approximately $6.1 million compared to $7.6 million in the first quarter of 2022, a decrease of approximately 20%. The decrease was primarily due to lower development spending, offset by increases in legal, audit and advisory fees associated with both the proposed merger transaction with DMK and the March financing transaction.

· Net loss for the combined (continued and discontinued) operations for the first quarter of 2023 was approximately $8.9 million compared to a net loss of $10.4 million in the first quarter of 2022, a decrease of approximately 14%.

· Cash and cash equivalents as of March 31, 2023, were approximately $3.1 million.

Conference Call Information

Management will host a live webcast/conference call today, May 15, 2023, at 2:00 p.m. PT / 5:00 p.m. ET, during which Company executives will review financial information for the first quarter of 2023 and provide a corporate update, which may include an update concerning the results of the Company’s special meeting of stockholders held on May 15, 2023, as well as concerning the proposals acted upon at the meeting.

U.S. Dial-in (Toll Free): 1-877-423-9813

Toll/International Dial-in: 1-201-689-8573

A live audio webcast of the conference call will also be available via this link. If you are unable to participate in the live call, a replay will be available shortly after the live event. To listen to the replay please visit the events page of the Adamis investor relations section of the company website at View Source