As previously disclosed, on July 13, 2020, Bio-Path Holdings, Inc. (the "Company") entered into an At-TheMarket Offering Agreement (the "Offering Agreement") with H. C. Wainwright & Co., LLC ("Wainwright"), as sales
agent and/or principal, pursuant to which the Company could offer and sell, from time to time, through or to
Wainwright, shares of the Company’s common stock, par value $0.001 per share ("Common Stock").

On December 7, 2022, the Company received written notice from Wainwright that Wainwright had elected,
pursuant to Section 8(b) of the Offering Agreement, to terminate the Offering Agreement effective as of December 7,
2022. The Company will not incur any material early termination penalties in connection with the termination of the
Offering Agreement.

As of immediately prior to the termination of the Offering Agreement, offers and sales of shares of Common
Stock under the Offering Agreement were being made pursuant to a shelf registration statement on Form S-3 filed with
the U.S. Securities and Exchange Commission (the "Commission"), which was declared effective by the Commission on
June 14, 2022 (File No. 333-265282) (the "2022 Shelf Registration Statement"), and a related prospectus filed with the
Commission on June 14, 2022, as supplemented and amended pursuant to a prospectus supplement filed with the
Commission on July 29, 2022 (as supplemented and amended, the "ATM Prospectus"). The ATM Prospectus covered
the offer and sale of shares of Common Stock having a maximum aggregate offering price of up to $3.0 million.

As of immediately prior to the termination of the Offering Agreement, all $3.0 million of shares of Common
Stock remained available for sale pursuant to the ATM Prospectus and the Offering Agreement. As a result of the
termination of the Offering Agreement, the Company will not offer or sell any additional shares of Common Stock under
the ATM Prospectus or the Offering Agreement, and the entire $3.0 million of shares of Common Stock included in
ATM Prospectus will be available for sale in other offerings pursuant to the 2022 Shelf Registration Statement.

A copy of the Offering Agreement was filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K
filed with the Commission on July 14, 2020. The description of the Offering Agreement contained in this Current Report
on Form 8-K does not purport to be complete and is qualified in its entirety by reference to the Offering Agreement.

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On December 9, 2022, the Food and Drug Administration (FDA) reported that it approved atezolizumab (Tecentriq, Genentech, Inc.) for adult and pediatric patients 2 years of age and older with unresectable or metastatic alveolar soft part sarcoma (ASPS) (Press release, US FDA, DEC 9, 2022, View Source [SID1234625694]).

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Efficacy was evaluated in Study ML39345 (NCT03141684), an open-label, single-arm study in 49 adult and pediatric patients with unresectable or metastatic ASPS. Eligible patients were required to have histologically or cytologically confirmed ASPS incurable by surgery and an ECOG performance status of ≤2. Patients were excluded for primary central nervous system (CNS) malignancy or symptomatic CNS metastases, clinically significant liver disease, or a history of idiopathic pulmonary fibrosis, pneumonitis, organizing pneumonia, or active pneumonitis on imaging. Adult patients received 1200 mg intravenously and pediatric patients received 15 mg/kg (up to a maximum of 1200 mg) intravenously once every 21 days until disease progression or unacceptable toxicity.

The main efficacy outcome measures were overall response rate (ORR) and duration of response (DOR) determined by an independent review committee using RECIST v1.1. ORR was 24% (95% CI: 13, 39). Of the 12 patients who experienced an objective response, 67% had a DOR of 6 months or more, and 42% had a DOR of 12 months or more.

The median patient age was 31 years (range: 12-70); 47 adult patients (2% were ≥65 years of age) and 2 pediatric patients ≥12 years of age were enrolled; 51% were female, 55% White, 29% Black or African American, 10% Asian.

The most common adverse reactions (≥15%) were musculoskeletal pain (67%); fatigue (55%); rash (47%); cough (45%); nausea, headache, and hypertension (43% each), vomiting (37%), constipation and dyspnea (33% each), dizziness and hemorrhage (29% each), insomnia and diarrhea (27% each), pyrexia, anxiety, abdominal pain and hypothyroidism (25% each), decreased appetite and arrhythmia (22% each), influenza-like illness and weight decreased (18% each), and allergic rhinitis and weight increased (16% each).

The recommended atezolizumab dosage for adult patients is 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks until disease progression or unacceptable toxicity. The recommended dosage for pediatric patients 2 years of age and older is 15 mg/kg (up to a maximum of 1200 mg) every 3 weeks until disease progression or unacceptable toxicity.

View full prescribing information for Tecentriq.

This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment. The FDA approved this application 3 weeks ahead of the FDA goal date.

This application was granted priority review and breakthrough designation. A description of FDA expedited programs is in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics. The application also was granted orphan drug designation.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.

For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate at 240-402-0004 or email [email protected]

As previously disclosed, on July 13, 2020, Bio-Path Holdings, Inc. (the "Company") entered into an At-The Market Offering Agreement (the "Offering Agreement") with H. C. Wainwright & Co., LLC ("Wainwright"), as sales agent and/or principal, pursuant to which the Company could offer and sell, from time to time, through or to Wainwright, shares of the Company’s common stock, par value $0.001 per share ("Common Stock") (Filing, Bio-Path Holdings, DEC 9, 2022, View Source [SID1234625298]).

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On December 7, 2022, the Company received written notice from Wainwright that Wainwright had elected,
pursuant to Section 8(b) of the Offering Agreement, to terminate the Offering Agreement effective as of December 7, 2022. The Company will not incur any material early termination penalties in connection with the termination of the Offering Agreement.

As of immediately prior to the termination of the Offering Agreement, offers and sales of shares of Common
Stock under the Offering Agreement were being made pursuant to a shelf registration statement on Form S-3 filed with the U.S. Securities and Exchange Commission (the "Commission"), which was declared effective by the Commission on June 14, 2022 (File No. 333-265282) (the "2022 Shelf Registration Statement"), and a related prospectus filed with the Commission on June 14, 2022, as supplemented and amended pursuant to a prospectus supplement filed with the Commission on July 29, 2022 (as supplemented and amended, the "ATM Prospectus"). The ATM Prospectus covered the offer and sale of shares of Common Stock having a maximum aggregate offering price of up to $3.0 million.

As of immediately prior to the termination of the Offering Agreement, all $3.0 million of shares of Common
Stock remained available for sale pursuant to the ATM Prospectus and the Offering Agreement. As a result of the
termination of the Offering Agreement, the Company will not offer or sell any additional shares of Common Stock under the ATM Prospectus or the Offering Agreement, and the entire $3.0 million of shares of Common Stock included in ATM Prospectus will be available for sale in other offerings pursuant to the 2022 Shelf Registration Statement.

A copy of the Offering Agreement was filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K
filed with the Commission on July 14, 2020. The description of the Offering Agreement contained in this Current Report on Form 8-K does not purport to be complete and is qualified in its entirety by reference to the Offering Agreement.

On December 9, 2022, Vor Biopharma Inc. (the "Company") notified Jefferies LLC ("Jefferies") of its decision to terminate the Open Market Sale AgreementSM, dated as of March 14, 2022, (the "Sales Agreement") between the Company and Jefferies, effective as of December 22, 2022 (the "Termination Date") (Filing, 8-K, Vor BioPharma, DEC 9, 2022, View Source [SID1234625275]). The Sales Agreement provided for the offer and sale of the Company’s common stock, par value $0.0001 per share ("Common Stock"), from time to time through Jefferies as its sales agent, subject to the maximum aggregate dollar amount registered pursuant to the applicable prospectus supplement. Sales of shares of Common Stock through Jefferies were to be made (A) in negotiated transactions with the consent of the Company or (B) by any other method permitted by law deemed to be an "at-the-market" offering as defined in Rule 415(a)(4) under the Securities Act of 1933, as amended, including block transaction, sales made directly on the Nasdaq Global Select Market or sales made into any other existing trading market for the shares of Common Stock. Through the Termination Date, the Company sold an aggregate of 856,030 shares of Common Stock under the Sales Agreement for net proceeds of $4.3 million.

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The foregoing description of the Sales Agreement is not complete and is qualified in its entirety by reference to the full text of the Sales Agreement, a copy of which was filed as Exhibit 1.2 to the Company’s Registration Statement on Form S-3 filed with the SEC on March 14, 2022.

On December 9, 2022, Seres Therapeutics, Inc. (the "Company") entered into the First Amendment to Lease (the "First Amendment") with BMR-Sidney Research Campus LLC (f/k/a BMR 200-Sidney Street LLC), a Delaware limited liability company (the "Landlord"), which amends the Lease Agreement, dated November 11, 2015, by and between the Company and the Landlord (as amended, the "Lease"), pursuant to which the Company leases approximately 83,396 rentable square feet of office, laboratory, and pilot manufacturing space located at 200 Sidney Street, Cambridge, Massachusetts (the "Existing Premises") (Filing, 8-K, Seres Therapeutics, DEC 9, 2022, View Source [SID1234625269]).

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The First Amendment provides for (i) effective as of November 12, 2023, the surrender by the Company to the Landlord of an aggregate area of approximately 14,760 rentable square feet of the Existing Premises, (ii) the extension of the expiration date of the term of the Lease with respect to the remaining 68,636 rentable square feet of the Existing Premises (the "Renewal Premises") from November 13, 2023 to January 13, 2030 and (iii) effective as of November 13, 2023, the adjustment of the base rent the Company is obligated to pay the Landlord for the Renewal Premises to $122.00 per rentable square foot of the Renewal Premises per year, subject to an annual adjustment.

The foregoing description of the First Amendment does not purport to be complete and is qualified in its entirety by reference to the full text of the First Amendment, which is attached hereto as Exhibit 10.1 and incorporated herein by reference.